Publications by authors named "Philip van Kerrebroeck"

149 Publications

Sacral neuromodulation in patients with refractory overactive bladder symptoms after failed Botulinum toxin therapy: Results in a large cohort of patients.

Neurourol Urodyn 2021 Apr 8. Epub 2021 Apr 8.

Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.

Aims: Sacral neuromodulation (SNM) and Botulinum toxin A (BoNT-A) injections are well-known third-line treatment options in patients with refractory overactive bladder (OAB). Our aim is to evaluate the success rate of SNM in patients who received prior therapy with BoNT-A injections.

Methods: All patients with OAB symptoms referred for SNM between 2006 and 2019 were included. History taking and 3-day voiding diaries assessed the complaints and suitability for SNM. The success rate of SNM in patients who received prior BoNT-A was compared with BoNT-A naive patients. Success was defined as an improvement of 50% or greater in voiding diary parameters. Satisfaction was registered at their most recent visit.

Results: A total of 263 patients underwent SNM test stimulation, of which 75 (16 male/57 female) received prior BoNT-A and 188 (46 male/142 female) were BoNT-A naive. Success rate for SNM in BoNT-A naive patients was 72.9% and in BoNT-A patients 66.7% (p = 0.316). Success rate after ≤2 BoNT-A injections was 68.5%, compared to 61.1% after ≥3 injections (p >  0.05). Success rate in patients perceiving lack of efficacy of BoNT-A was 67.4% (p > 0.05), subjected to temporary CISC was 73.7% (p > 0.05) and with temporary effect of BoNT-A was 50% (p > 0.05). In 86% of BoNT-A patients the system was still activated and used to their satisfaction at their last follow-up visit (mean FU, 40.70 months).

Conclusion: SNM in patients with refractory OAB who failed prior BoNT-A is an excellent approach. The number of injections nor reason of BoNT-A discontinuation have predictive value for success with SNM.
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http://dx.doi.org/10.1002/nau.24670DOI Listing
April 2021

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

Neurourol Urodyn 2021 02 28;40(2):714-721. Epub 2021 Jan 28.

Cleveland Clinic, Cleveland, Ohio, USA.

Aims: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented.

Methods: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented.

Results: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred.

Conclusions: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.
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http://dx.doi.org/10.1002/nau.24615DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986436PMC
February 2021

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence.

Neurourol Urodyn 2020 06 27;39(5):1482-1488. Epub 2020 Apr 27.

University of California, Irvine, California.

Aims: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented.

Methods: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants.

Results: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events.

Conclusions: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.
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http://dx.doi.org/10.1002/nau.24376DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384085PMC
June 2020

Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system.

Neurourol Urodyn 2020 04 3;39(4):1108-1114. Epub 2020 Apr 3.

Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, UK.

Aims: Sacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long-term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2-year outcomes.

Methods: A total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow-up visits. Adverse events (AEs) are reported in all implanted subjects.

Results: At 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device-related AEs.

Conclusions: The Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device-related AEs. Subjects reported continued satisfaction with their therapy.
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http://dx.doi.org/10.1002/nau.24317DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217215PMC
April 2020

The effect of continuous positive airway pressure on nocturia in patients with obstructive sleep apnea syndrome.

Neurourol Urodyn 2020 04 3;39(4):1124-1128. Epub 2020 Mar 3.

Department of Urology, University Hospital Maastricht, Maastricht, The Netherlands.

Objective: The prevalence of nocturia in patients with obstructive sleep apnea syndrome (OSAS) who received continuous positive airways pressure (CPAP) treatment was studied as well as the effect of CPAP treatment on nocturia.

Methods: All patients that were referred to the pulmonology department of a large teaching hospital in the Netherlands and received a CPAP mask for OSAS were interviewed and invited to take part in the study (N = 274). After informed consent, all patients were asked about the number of nocturia episodes before and after CPAP.

Results: In this prospective analysis, 274 patients (190 male and 84 female) were included. The mean age was 60.3 years (SE = 0.7). Sixty-four patients (23.4%) reported no nocturia episodes before CPAP and 210 patients (76.4%) reported ≥1 nocturia episode(s). Treatment of OSAS with CPAP reduced nocturia with one or more episodes per night in 42.3% of the patients. Clinically relevant nocturia (≥2 voids per night) was reduced from 73.0% to 51.5%. There were no statistically significant gender differences.

Conclusion: The prevalence of nocturia in patients diagnosed with OSAS is 75.8% in both sexes. After treatment with CPAP, almost half of patients experienced a decrease in the nocturia frequency of one or more voids. Clinically relevant nocturia was reduced with one-third after CPAP. CPAP not only reduced the number of voids during the night but also improved the associated quality of life.
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http://dx.doi.org/10.1002/nau.24329DOI Listing
April 2020

New Technologies and Applications in Sacral Neuromodulation: An Update.

Adv Ther 2020 02 24;37(2):637-643. Epub 2019 Dec 24.

Department of Urology, Maastricht University, Maastricht, The Netherlands.

Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.
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http://dx.doi.org/10.1007/s12325-019-01205-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7004424PMC
February 2020

Pathophysiological Mechanisms of Nocturia and Nocturnal Polyuria: The Contribution of Cellular Function, the Urinary Bladder Urothelium, and Circadian Rhythm.

Urology 2019 Nov 29;133S:14-23. Epub 2019 Jul 29.

Maastricht University Medical Center, Maastricht, The Netherlands.. Electronic address:

Alterations to arginine vasopressin (AVP) secretion, the urinary bladder urothelium (UT) and other components of the bladder, and the water homeostasis biosystem may be relevant to the pathophysiology of nocturia and nocturnal polyuria (NP). AVP is the primary hormone involved in water homeostasis. Disruption to the physiological release of AVP or its target effects may relate to several urinary disturbances. Circadian dysregulation and the effects of aging, for example, the development of oxidative stress and mitochondrial dysfunction, may play a role in nocturia voiding symptoms. The urinary bladder UT not only acts as a highly efficient barrier that is maintained during the filling and voiding of the urinary bladder, but is also capable of sensory and transducer function through a network of functional receptors and ion channels that enable reciprocal communication between UT cells and neighboring elements of the bladder mucosa and wall. Functional components of the UT (eg, claudins and receptors or ion channels) play important roles in AVP-mediated water homeostasis. These components and functions involved in water homeostasis, as well as kidney function, may be affected by the aging process, including age-related mitochondrial dysfunction. The characteristics of NP are discussed and the association between NP and circadian rhythm is examined in light of reports that suggest that nocturia should be considered as a type of circadian dysfunction. Many possible pathologic mechanisms that underlie nocturia and NP have been identified. Future studies may provide further insight into pathophysiology with the hope of identifying new treatment modalities.
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http://dx.doi.org/10.1016/j.urology.2019.07.020DOI Listing
November 2019

Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.

J Urol 2020 01 26;203(1):185-192. Epub 2019 Jul 26.

Cleveland Clinic, Cleveland, Ohio.

Purpose: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented.

Materials And Methods: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants.

Results: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events.

Conclusions: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.
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http://dx.doi.org/10.1097/JU.0000000000000458DOI Listing
January 2020

First-in-human implantation of a mid-field powered neurostimulator at the sacral nerve: Results from an acute study.

Neurourol Urodyn 2019 08 20;38(6):1669-1675. Epub 2019 May 20.

Department of Urology and Obstetrics and Gynecology, Stanford University Medical Center, Stanford, California.

Introduction: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve.

Materials And Methods: A first-in-human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used.

Results: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred.

Conclusions: The results from this acute first-in-human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid-field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.
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http://dx.doi.org/10.1002/nau.24035DOI Listing
August 2019

International Continence Society consensus on the diagnosis and treatment of nocturia.

Neurourol Urodyn 2019 02 19;38(2):478-498. Epub 2019 Feb 19.

Urology Department, University of Philadelphia, Philadelphia, Pennsylvania.

Introduction: Patients with nocturia have to face many hurdles before being diagnosed and treated properly. The aim of this paper is to: summarize the nocturia patient pathway, explore how nocturia is diagnosed and treated in the real world and use the Delphi method to develop a practical algorithm with a focus on what steps need to be taken before prescribing desmopressin.

Methods: Evidence comes from existing guidelines (Google, PubMed), International Consultation on Incontinence-Research Society (ICI-RS) 2017, prescribing information and a Delphi panel (3 rounds). The International Continence Society initiated this study, the authors represent the ICI-RS, European Association of Urology, and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU).

Results: Diagnostic packages: consensus on, history taking for all causalities, intake diary (fluid, food) and bladder diary, not for its duration. Pelvic (women) or rectal (men) examination, prostate-specific antigen, serum sodium check (SSC), renal function, endocrine screening: when judged necessary. Timing or empty stomach when SSC is not important. Therapeutic packages: the safe candidates for desmopressin can be phenotyped as no polydipsia, heart/kidney failure, severe leg edema or obstructive sleep apnea syndrome. Lifestyle interventions may be useful. Initiating desmopressin: risk management consensus on three clinical pictures. Follow-up of desmopressin therapy: there was consensus on SSC day 3 to 7, and at 1 month. Stop therapy if SSC is <130 mmol/L regardless of symptoms. Stop if SSC is 130 to 135 mmol/L with symptoms of hyponatremia.

Conclusion: A summary of the nocturia patient pathway across different medical specialists is useful in the visualization and phenotyping of patients for diagnosis and therapy. By summarizing basic knowledge of desmopressin, we aim to ease its initiation and shorten the patient journey for nocturia.
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http://dx.doi.org/10.1002/nau.23939DOI Listing
February 2019

The Value of Ambulatory Urodynamics in the Evaluation of Treatment Effect of Sacral Neuromodulation.

Urol Int 2019 4;102(3):299-305. Epub 2019 Jan 4.

Department of Urology, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.

Objectives: To assess the improvement of symptoms by sacral neuromodulation (SNM) in an objective way by carrying out an ambulatory urodynamic study (ambulatory-UDS). Until now, successful treatment has been defined as a ≥50% improvement recorded on voiding diaries. Voiding diaries are a patient reported outcome tool. A tool with less bias is desired to evaluate the treatment results before an expensive permanent system is implanted.

Methods: Between 2002 and 2015, a total of 334 patients with lower urinary tract symptoms were included consecutively in an ambulatory-UDS database. From this database, a subgroup of patients was selected which underwent SNM.

Results: In 51 patients, an ambulatory-UDS was performed both at baseline and during the SNM test period. A positive treatment outcome after test stimulation based on the patients' voiding diary, correlated (p < 0.0001) with an improvement on ambulatory-UDS. Twenty-six of the 30 patients, who have showed improvement of more than 50% on voiding diary parameters and who had subjective improvement of their symptoms, showed an early improvement on ambulatory-UDS.

Conclusions: Ambulatory-UDS can be used in clinical decision making, as it is associated with voiding diary improvement during the SNM test period. Using ambulatory-UDS to confirm success could in the future justify the shortening of the test period.
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http://dx.doi.org/10.1159/000493988DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6518866PMC
December 2019

A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.

Neurourol Urodyn 2019 02 28;38(2):689-695. Epub 2018 Dec 28.

Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, United Kingdom.

Aims: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system.

Methods: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs).

Results: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances.

Conclusions: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.
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http://dx.doi.org/10.1002/nau.23892DOI Listing
February 2019

The efficacy of mirabegron in the treatment of urgency and the potential utility of combination therapy.

Ther Adv Urol 2018 Aug 6;10(8):243-256. Epub 2018 Jul 6.

Maastricht University Medical Centre, Maastricht, The Netherlands.

Urgency is the prevalent and most bothersome symptom of overactive bladder (OAB) and the treatment of urgency is the primary objective in the management of OAB. Urgency has a major impact on other symptoms of OAB and culminates in an increased frequency of micturition and reduced volume voided, which may contribute to shorter intervals between the need to void. Antimuscarinic agents and mirabegron, a β-adrenoceptor agonist, constitute the main oral pharmacotherapeutic options for the treatment of urgency and other OAB symptoms. The reduction of urgency and other OAB symptoms significantly improve health-related quality of life. This review will explore the distinct mechanisms of action and effects of antimuscarinic agents and mirabegron, in relation to their effect on the pathophysiology of urgency. The review will also provide an overview of the various validated measurements of urgency and the numerous clinical trials regarding antimuscarinic agent monotherapy, mirabegron monotherapy, or combination treatment with mirabegron added on to the antimuscarinic agent solifenacin. A narrative review of the literature relating to pathophysiology of urgency, the validated measurements of urgency, and clinical trials relating to the pharmacological treatment of urgency. Antimuscarinic agent monotherapy, mirabegron monotherapy, or combination treatment with mirabegron added on to the antimuscarinic agent solifenacin statistically significantly reduce the symptoms of urgency compared with placebo. Combination therapy with mirabegron added on to solifenacin also statistically significantly reduces the symptoms of severe urgency compared with antimuscarinic agent monotherapy. A critique of the clinical benefits of combination therapy is also provided. Combination therapy provides an alternative treatment in patients with OAB that includes urgency who respond poorly to first-line monotherapy and who may otherwise often move on to more invasive treatments.
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http://dx.doi.org/10.1177/1756287218781255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6048625PMC
August 2018

Affective symptoms and quality of life in patients with voiding or storage dysfunction: Results before and after sacral neuromodulation: A prospective follow-up study.

Neurourol Urodyn 2018 06 5;37(5):1801-1808. Epub 2018 Mar 5.

Department of Urology, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.

Aims: Sacral neuromodulation (SNM) is an effective treatment for patients with overactive bladder syndrome (OAB) or non-obstructive urinary retention (NOR). These lower urinary tract symptoms (LUTS) are the result of a functional urological cause but often coincide with psychological and/or psychiatric factors. It has been stated that there is an association between LUTS, depression and anxiety disorders. With this study we will investigate whether affective symptoms and quality of life (QoL) improve after successful SNM.

Methods: All patients eligible for SNM between March 2013 and March 2016, filled out the HADS (Hospital Anxiety and Depression Scale), SF-36 (Short Form-36) and either the International Consultation on Incontinence Modular Questionnaire (ICIQ) on Male/Female Lower Urinary Tract Symptoms (M/F-LUTS), or the OAB-q questionnaire, before and after the test procedure. Symptom improvement of ≥50% was considered as success. Results were analyzed by paired T-tests and the Wilcoxon signed-rank test.

Results: In total 95 patients were included. Mean age was 52.1 (SD 13.9). Fifty-six patients (59%) were implanted. Successful OAB patients reported a significant improvement in all domains of OAB-q, health change and affective symptoms. Successful NOR patients showed a significant improvement in voiding symptoms (P = 0.04) and health change (P = 0.03). However, they did not report significant improvement in affective symptoms.

Conclusion: QoL and affective symptoms can significantly improve in LUTS patients who are successfully treated with SNM. When divided per indication, a significant improvement in affective symptoms together with QoL was only reported in successful OAB patients and not in successfully treated NOR patients.
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http://dx.doi.org/10.1002/nau.23527DOI Listing
June 2018

Pharmacotherapy for Nocturia.

Curr Urol Rep 2018 Feb 9;19(1). Epub 2018 Feb 9.

Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands.

Purpose Of Review: To assess current pharmacological principles used for treatment of nocturia/nocturnal polyuria.

Recent Findings: The pathophysiology of nocturia is often multifactorial, but two main mechanisms have been identified, occurring alone or in combination: low functional bladder capacity and nocturnal polyuria. The multifactorial pathophysiology not only implies several possible targets for therapeutic intervention but also means that it is unlikely that one treatment modality including drugs will be successful in all patients. Drugs approved for the treatment of male LUTS and male and female OAB are known to be far more effective for treatment of the daytime symptoms than for nocturia. Several pharmacological principles have been tested with varying success. The treatment of choice should depend upon the main underlying cause, thus aiming primarily to increase bladder capacity by counteracting detrusor overactivity and/or reducing nocturnal polyuria. Using current available agents, effective, personalized treatment should be designed taking into account gender, co-morbidities, and identified etiological factors. However, there is a medical need for new, approved drugs for treatments for patients with nocturia.
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http://dx.doi.org/10.1007/s11934-018-0750-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5807446PMC
February 2018

Programming settings and recharge interval in a prospective study of a rechargeable sacral neuromodulation system for the treatment of overactive bladder.

Neurourol Urodyn 2018 02 16;37(S2):S17-S22. Epub 2018 Jan 16.

Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, United Kingdom.

Aims: The RELAX-OAB study is designed to confirm the safety, efficacy, and technical performance of the Axonics r-SNM System, a miniaturized, rechargeable SNM system approved in Europe and Canada for the treatment of bladder and bowel dysfunction. The purpose of this article is to describe study subjects' ability to charge the rechargeable neurostimulator and to document their neurostimulator program settings and recharge interval over time.

Methods: Fifty-one OAB patients were implanted in a single-stage procedure. These results represent the 3-month charging experience for 48 subjects who completed the 3-month follow-up. Recharge intervals were estimated using therapy stimulation settings and subject experience was evaluated using questionnaires.

Results: Forty-seven of forty-eight (98%) subjects were able to successfully charge their device prior to follow-up within 1-month post-implant. At 3-month post-implant, 98% of subjects were able to charge prior to their follow-up visit. Average stimulation amplitude across all subjects was 1.8 mA (±1.1 mA). A total of 69% of subjects had ≥14-day recharge intervals (time between charging) and 98% of subjects had ≥7-day recharge interval. No charging related adverse events occurred.

Conclusions: Study subjects were able to charge the Axonics r-SNM System and stimulation settings provided 2 weeks of therapy between recharging for most subjects. Subject satisfaction indicates that subjects are satisfied with rechargeable SNM therapy.
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http://dx.doi.org/10.1002/nau.23476DOI Listing
February 2018

Three month clinical results with a rechargeable sacral neuromodulation system for the treatment of overactive bladder.

Neurourol Urodyn 2018 02 5;37(S2):S9-S16. Epub 2018 Jan 5.

Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, United Kingdom.

Aims: The primary aim of the RELAX-OAB study is to confirm the safety and efficacy of the Axonics r-SNM System, a miniaturized, rechargeable SNM system.

Methods: A total of 51 OAB patients were implanted in a single-stage implant procedure. These results represent the 3-month outcomes. Subject outcomes were evaluated using 3-day bladder diaries and quality of life questionnaires.

Results: A total of 31 of 34 patients (91%) that responded during an initial trial period ("Test Responders") continued to benefit from therapy with the Axonics r-SNM System at 3-months, defined as symptom improvement of ≥50% reduction in urinary voids or incontinence episodes or a return to <8 voids per day. Subjects who were Test Responders showed a statistically and clinically meaningful improvement in all aspects of quality of life (ICIQ-OABqol). No serious device-related adverse events (SADEs) occurred, and there were no unanticipated adverse events (UAEs). One subject was explanted due to an infection at the implant site and 19.6% of subjects experienced device related adverse events, most notably discomfort due to stimulation, which was resolved with reprogramming.

Conclusions: The Axonics r-SNM System provides safe and effective SNM therapy with objective improvement in 91% of subjects. The data also demonstrates a significant improvement in all domains of quality of life. This miniaturized, rechargeable system is designed to last 15 or more years and is expected to provide clinical and cost benefits over current non-rechargeable systems by eliminating replacement surgeries.
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http://dx.doi.org/10.1002/nau.23465DOI Listing
February 2018

Onset of Action of Sacral Neuromodulation in Lower Urinary Tract Dysfunction-What is the Optimal Duration of Test Stimulation?

J Urol 2018 06 29;199(6):1584-1590. Epub 2017 Dec 29.

School of Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.

Purpose: Since the development of sacral neuromodulation, a large number of patients with lower urinary tract symptoms have been treated with this procedure. A test stimulation is performed prior to implantation. At centers worldwide the duration of this test stimulation varies considerably since it is not certain when the onset of the therapy effect can be expected. The objective of this prospective study was to evaluate the average onset time of sacral neuromodulation in patients with lower urinary tract symptoms.

Materials And Methods: All patients who were eligible for treatment with sacral neuromodulation were asked to participate in this study. A voiding diary was filled out prior to and during test stimulation using an implanted tined lead. Success was defined as a 50% or greater improvement compared to baseline in any of the main complaint parameters. The Mann-Whitney U test was used to compare the mean time to success between patients with overactive bladder syndrome and patients with nonobstructive urinary retention.

Results: Of the 45 patients 24 with nonobstructive urinary retention and 21 with overactive bladder syndrome agreed to participate and were included in study. Test stimulation was successful in 29 patients (64%). Mean time to success in all patients was 3.3 days (range 1 to 9). There was no significant difference in mean time to success between cases of overactive bladder syndrome and nonobstructive urinary retention (3.25 and 3.5 days, respectively, p = 0.76).

Conclusions: The results imply that a test stimulation of more than 2 weeks is not necessary if a cutoff of 50% or greater improvement is adopted. However, further improvement can be expected with prolonged test stimulation. This might be important since it might have implications for long-term results.
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http://dx.doi.org/10.1016/j.juro.2017.12.053DOI Listing
June 2018

A practical approach to the management of nocturia.

Int J Clin Pract 2017 Nov 5;71(11). Epub 2017 Oct 5.

Department of Urology, Ghent University Hospital, Ghent, Belgium.

Aim: To raise awareness on nocturia disease burden and to provide simplified aetiologic evaluation and related treatment pathways.

Methods: A multidisciplinary group of nocturia experts developed practical advice and recommendations based on the best available evidence supplemented by their own experiences.

Results: Nocturia is defined as the need to void ≥1 time during the sleeping period of the night. Clinically relevant nocturia (≥2 voids per night) affects 2%-18% of those aged 20-40 years, rising to 28%-62% for those aged 70-80 years. Consequences include the following: lowered quality of life; falls and fractures; reduced work productivity; depression; and increased mortality. Nocturia-related hip fractures alone cost approximately €1 billion in the EU and $1.5 billion in the USA in 2014. The pathophysiology of nocturia is multifactorial and typically related to polyuria (either global or nocturnal), reduced bladder capacity or increased fluid intake. Accurate assessment is predicated on frequency-volume charts combined with a detailed patient history, medicine review and physical examination. Optimal treatment should focus on the underlying cause(s), with lifestyle modifications (eg, reducing evening fluid intake) being the first intervention. For patients with sustained bother, medical therapies should be introduced; low-dose, gender-specific desmopressin has proven effective in nocturia due to idiopathic nocturnal polyuria. The timing of diuretics is an important consideration, and they should be taken mid-late afternoon, dependent on the specific serum half-life. Patients not responding to these basic treatments should be referred for specialist management.

Conclusions: The cause(s) of nocturia should be first evaluated in all patients. Afterwards, the underlying pathophysiology should be treated specifically, alone with lifestyle interventions or in combination with drugs or (prostate) surgery.
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http://dx.doi.org/10.1111/ijcp.13027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698733PMC
November 2017

Sacral Neuromodulation: Standardized Electrode Placement Technique.

Neuromodulation 2017 Dec 4;20(8):816-824. Epub 2017 Oct 4.

Department of Urology, University Hospital Antwerpen, Antwerpen, Belgium.

Introduction: Sacral neuromodulation (SNM) (sacral nerve stimulation SNS) has become an established therapy for functional disorders of the pelvic organs. Despite its overall success, the therapy fails in a proportion of patients. This may be partially due to inadequate electrode placement with suboptimal coupling of the electrode and nerve. Based on these assumptions the technique of sacral spinal neuromodulation has been redefined. All descriptions relate to the only currently available system licensed for all pelvic indications (Medtronic Interstim ).

Method: An international multidisciplinary working party of ten individuals highly experienced in performing SNM convened two meetings (including live operating) to standardize the implant procedure. This report addresses the main steps to optimal electrode lead placement in temporal sequence.

Results: Key elements of the electrode placement are radiological marking, the use of a curved stylet, the entry of the electrode into the sacral foramen and its progression through the foramen, its placement guided by a combination of a typical appearance in fluoroscopy and achieving specific motor/sensory responses with stimulation. The report describes quadripolar electrode placement and then either insertion of a connecting percutaneous extension lead or permanent implantation of the programmable device.

Conclusion: Standardization of electrode placement may ensure close electrode proximity to the target nerve providing a higher likelihood for optimal effect with less energy consumption (better battery longevity), more programming options with more electrode contacts close to the nerve and reduced likelihood of side-effects. The potentially better clinical outcome needs to be demonstrated.
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http://dx.doi.org/10.1111/ner.12695DOI Listing
December 2017

Editorial Comment.

J Urol 2018 01 29;199(1):236. Epub 2017 Sep 29.

Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands.

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http://dx.doi.org/10.1016/j.juro.2017.07.103DOI Listing
January 2018

A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints.

Neurourol Urodyn 2018 03 11;37(3):1060-1067. Epub 2017 Sep 11.

Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, UK.

Background: Overactive bladder is a chronic condition affecting lower urinary tract function that has a significant negative impact on QoL.

Objective: Evaluation of the BlueWind implantable tibial nerve system performance and safety in refractory OAB.

Design, Setting, And Participants Intervention: A 6-month multi-center prospective intervention study.

Outcome Measurements And Statistical Analysis: Objective assessment was done by voiding diary parameters including voids/day, volume voided/day, urgency assessment, leaking episodes/day, pads used/day, leak severity, and clinical success defined as a ≥50% reduction in the number of leaks/day or number of voids/day or number of episodes with degree of urgency >2 or a return to <8 voids/day on a 3 Day diary. Subjective assessment was based on OAB-q including HRQL and symptom severity score. Safety was evaluated by adverse event (AE) analysis.

Results And Limitations: Thirty-four of the 36 implanted subjects completed the study. One subject withdrew voluntarily and one developed inflammation necessitating removal of the system. In the remaining subjects, 71% experienced clinical success at 6 months. Leaks/day, leak severity, and pad changes/day decreased significantly over time with 27.6% of urge incontinence subjects that became "dry." Voids/day, degree of urgency, volume/void, pads changed improved significantly. All quality of life aspects (concern, coping, sleep, and social) improved as well as symptom severity scores measured by the OAB-q. Adverse events included: implant site pain (13.9%), suspected infection (22.2%), and procedural wound complications (8.3%).

Conclusions: The BlueWind implantable tibial nerve stimulator is a safe, minimally invasive system that affords OAB patients significant improvements.

Patient Summary: The performance and safety of the BlueWind RENOVA™ implantable tibial nerve neuromodulator for OAB was tested. Our preliminary results demonstrate that the system has a low risk safety profile and may be considered an effective treatment option for OAB management.
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http://dx.doi.org/10.1002/nau.23401DOI Listing
March 2018

Optimal Lead Positioning in Sacral Neuromodulation: Which Factors Are Related to Treatment Outcome?

Neuromodulation 2017 Dec 6;20(8):830-835. Epub 2017 Sep 6.

Department of Urology, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.

Objectives: Sacral neuromodulation (SNM) is a well-established treatment for overactive bladder (OAB) and non-obstructive urinary retention (NOR). During test stimulation, the lead is positioned along the third sacral nerve, which ideally results in a response in all four contact points (active electrodes). However, it is unclear whether the position of the lead (depth, angle, deflection) and the number of active electrodes is related to the outcome of SNM.

Methods: All patients who underwent test stimulation using the tined lead between January 2011 and September 2016 were included in this retrospective study. Success was defined as >50% improvement in voiding diary parameters compared to baseline. The correlation between lead position and outcome of test stimulation was evaluated. The lead position was determined by evaluating the depth, angle and deflection with respect to the sacral foramen. Binary logistic regression was used in order to determine the predictive value of these factors.

Results: We included 189 patients of whom 105 were diagnosed with OAB and 84 with NOR. After a SNM test period of 4 weeks, 111 patients (59%) were successful and received a permanent implant. The position of the lead and the number of active electrodes did not predict success of test stimulation in neither the OAB group nor the NOR. However, lateral deflection of the lead was associated with finding more active electrodes (p = 0.01).

Conclusion: In our study, the position of the lead or the number of active electrodes did not predict the outcome of SNM test stimulation. However, the impact of lead positioning and number of active electrodes on long-term outcome remains to be proven.
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http://dx.doi.org/10.1111/ner.12649DOI Listing
December 2017

A populational-based survey on the prevalence, incidence, and risk factors of urinary incontinence in older adults-results from the "SABE STUDY".

Neurourol Urodyn 2018 01 30;37(1):466-477. Epub 2017 Jun 30.

Department of Urology, Maastricht University, Maastricht, The Netherlands.

Aims: To estimate the prevalence and incidence of urinary incontinence (UI) and identify the associated risk factors in a cohort of elderly individuals in Brazil.

Methods: In 2006, individuals aged ≥60 years were selected from the SABE Study (Health, Well-being, and Aging). The dependent variable was reported UI in 2009. UI was assessed using the International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form (ICIQ-UI SF). Incidence was measured in units of 1000 person-years, and Cox regression was applied for data analysis. Multivariate analysis was used to assess risk factors for UI. Incidence risk ratio (IRR) was used for comparison.

Results: This is the first study to examine the incidence of UI in Brazilian elderly individuals. In total, 1413 individuals were included; the mean age was 74.5 years, and 864 (61.8%) participants were female. The risk of UI was greater among women with cancer (other than skin) and among those with diabetes. In men, the risk of UI was greater for those in Instrumental Activities of Daily Living (IADL) category "5-8" and those who self-reported a "fair" health status. The prevalence of UI was 14.2% and 28.2% for men and women, respectively. The incidence rate of UI was 25.6 and 39.3 (×1000 person-years) for men and women, respectively.

Conclusions: The incidence rate of UI among older adults in the Brazilian community was high for elderly individuals. The identified risk factors were diabetes and IADL category 5-8 (women) as well as cancer (other than skin) and self-reported health status (male).
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http://dx.doi.org/10.1002/nau.23331DOI Listing
January 2018

Overactive bladder symptoms after midurethral sling surgery in women: Risk factors and management.

Neurourol Urodyn 2018 01 20;37(1):83-88. Epub 2017 Jun 20.

Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands.

Introduction: Overactive bladder syndrome (OAB) including urgency and urgency urinary incontinence (UUI) occurs frequently after stress urinary incontinence (SUI) surgery. It is important to identify the risk factors for the occurrence of OAB symptoms in order to adequately inform the patient before surgery. Furthermore, when facing OAB after sling surgery it is crucial to know how to manage these symptoms.

Methods: We conducted a literature review in order to assess the risk factors and management of OAB symptoms after SUI surgery. We searched for relevant articles in PubMed that specifically addressed the topic of OAB symptoms after midurethral sling surgery.

Results: The incidence of de novo and persistent urgency and UUI is reported around 15% and 30%, respectively. Several studies demonstrated that women with mixed incontinence who have a predominant urge component will have worse outcomes after surgery. Older age was also found to be a predictive factor in three studies. Furthermore, urodynamic signs of overactive bladder (eg, DO, low bladder capacity, elevated detrusor pressure) can predict postoperative urgency or UUI. The management of OAB symptoms after SUI surgery is essentially the same as in idiopathic OAB. However, before commencing therapy it is crucial to rule out other factors than can cause urgency, including bladder outlet obstruction, urinary tract infection, or sling erosion.

Conclusions: OAB symptoms are frequently reported after sling surgery. Women with mixed incontinence and older women are at risk of developing post-operative OAB symptoms. We have proposed an algorithm for the treatment of these symptoms which can be useful in clinical practice.
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http://dx.doi.org/10.1002/nau.23328DOI Listing
January 2018

The Impact of Duration of Complaints on Successful Outcome of Sacral Neuromodulation.

Urol Int 2017 6;99(1):51-55. Epub 2017 May 6.

Department of Urology, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.

Objectives: The study aimed to evaluate whether the duration of complaints in patients with overactive bladder syndrome or non-obstructive urinary retention predicts the outcome of sacral neuromodulation (SNM).

Methods: All patients that underwent a SNM test period evaluation between 2011 and 2014, were included in this study. The duration of complaints was listed in 3 categories: (a) 0-5 years, (b) 5-10 years and (c) 10 years or longer. Analyses with chi square tests were performed to evaluate whether the duration of complaints are associated with outcome of SNM.

Results: In total, 130 patients were included. Most patients had a complaint duration of 0-5 years (n = 60). The test period was successful in 56% (n = 74) of the total group. Analyses showed that the duration of complaints is not significantly associated with outcome of SNM (p = 0.752), even when subdivided per indication, and also when possible confounders such as age at test and indication are taken into account (p = 0.720).

Conclusion: Based on the results of this study, there is no relationship between duration of complaints and SNM outcome. SNM seems to remain a feasible treatment option, despite of possible anatomical or physiological changes within the lower urinary tract.
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http://dx.doi.org/10.1159/000456079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5637297PMC
May 2018

Incidence of urinary retention during treatment with single tablet combinations of solifenacin+tamsulosin OCAS™ for up to 1 year in adult men with both storage and voiding LUTS: A subanalysis of the NEPTUNE/NEPTUNE II randomized controlled studies.

PLoS One 2017 6;12(2):e0170726. Epub 2017 Feb 6.

Maastricht University Medical Center, Maastricht, The Netherlands.

Introduction: The emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs.

Materials And Methods: In NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months.

Results: Across both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%-1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%-1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/UR events occurred within 4 months of treatment initiation.

Conclusions: FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170726PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5293258PMC
August 2017

State of the art in intravesical gags therapy: from infection prevention to pain control.

Urologia 2016 Jun 23;83 Suppl 1:20. Epub 2016 Jun 23.

Department of Urology, University Vita-Salute San Raffaele, URI-Urological Research Institute, IRCCS Ospedale San Raffaele, Milano, Italy.

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http://dx.doi.org/10.5301/uro.5000182DOI Listing
June 2016

Understanding the pelvic pain mechanism is key to find an adequate therapeutic approach.

Urologia 2016 Jun 23;83 Suppl 1:2-4. Epub 2016 Jun 23.

Department of Urology, Maastricht University Medical Center, Maastricht - The Netherlands.

Pain is a natural mechanism to actual or potential tissue damage and involves both a sensory and an emotional experience. In chronic pelvic pain, localisation of pain can be widespread and can cause considerable distress. A multidisciplinary approach is needed in order to fully understand the pelvic pain mechanism and to identify an adequate therapeutic approach.
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http://dx.doi.org/10.5301/uro.5000183DOI Listing
June 2016