Publications by authors named "Linda Cardozo"

255 Publications

Healthcare professional's choice for surgical management of stress urinary incontinence in a U.K. tertiary hospital.

Eur J Obstet Gynecol Reprod Biol 2021 Aug 24;263:7-14. Epub 2021 May 24.

Department of Urogynaecology, King's College Hospital, London, UK.

Objective: In July 2018, NHS England, introduced a pause on vaginal mesh, including the mid-urethral sling (MUS) for treatment of stress urinary incontinence (SUI). NICE guidelines recommend MUS as one of the surgical options for SUI. The aim of our study was to investigate healthcare professionals choices for surgical treatment of SUI, if conservative measures failed.

Study Design: The urogynaecology department at our tertiary level hospital devised a questionnaire using SurveyMonkey. This was distributed via email to 1058 healthcare professionals of different medical backgrounds. The surgical options were based on the NICE guideline and its patient decision making aid. We also used surgical information from the British society of Urogynaecology (BSUG) and British association of urological surgeons (BAUS).

Results: We received 214 responses of which 204 were complete. Twenty six percent of replies were from obstetricians and gynaecologists, 36 % had over 20 years experience and 79 % were female. Forty four percent had no previous knowledge of surgical options. Mid-urethral sling was the most popular choice based on description, success and specific complications. Urethral bulking agent was the only option that increased in popularity after describing complications. Twenty two percent would avoid surgery due to the risk of complications.

Conclusion: This is the first study evaluating healthcare professionals surgical choice for SUI. Despite negative media publicity and NHS pause on MUS, it was still the most popular choice before and after informing of specific complications. The urethral bulking agent was the only surgical treatment, which increased in popularity after considering complications.
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http://dx.doi.org/10.1016/j.ejogrb.2021.05.039DOI Listing
August 2021

Weight loss with bariatric surgery or behaviour modification and the impact on female obesity-related urine incontinence: A comprehensive systematic review and meta-analysis.

Clin Obes 2021 Aug 6;11(4):e12450. Epub 2021 May 6.

Faculty of Life Sciences and Medicine, School of Life Course Sciences, King's College London, London, UK.

Women with obesity are at risk of pelvic floor dysfunction with a 3-fold increased incidence of urge urinary incontinence (UUI) and double the risk of stress urinary incontinence (SUI). The National Institute for Health and Care Excellence (NICE) and European Association of Urology (EAU) recommend that women with a body mass index ≥30 kg/m should consider weight loss prior to consideration for incontinence surgery. This systematic review and meta-analysis will assess this recommendation to aid in the counselling of women with obesity-related urinary incontinence (UI). Medical Literature Analysis and Retrieval System online (MEDLINE), EMBASE, Cochrane, ClinicalTrials.gov, and SCOPUS were systematically and critically appraised for all peer reviewed manuscripts that suitably fulfilled the inclusion criteria established a priori and presented original, empirical data relevant to weight loss intervention in the management of urinary incontinence. Thirty-three studies and their outcomes were meta-analysed. Weight loss interventions were associated in a decreased prevalence in UI (OR 0.222, 95% CI [0.147, 0.336]), SUI (OR 0.354, 95% CI [0.256, 0.489]), UUI (OR 0.437, 95% CI [0.295, 0.649]) and improved quality of life (PFDI-20, SMD -0.774 (95% CI [-1.236, -0.312]). This systematic review and meta-analysis provide evidence that weight loss interventions are effective in reducing the prevalence of obesity-related UI symptoms in women. Bariatric surgery in particular shows greater sustained weight loss and improvements in UI prevalence. Further large scale, randomized control trials assessing the effect of bariatric surgery on women with obesity-related UI are needed to confirm this study's findings.
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http://dx.doi.org/10.1111/cob.12450DOI Listing
August 2021

Modern management of genitourinary syndrome of menopause.

Fac Rev 2021 3;10:25. Epub 2021 Mar 3.

Department of Urogynaecology, King's College Hospital, London, UK.

The genitourinary syndrome of menopause (GSM) is the accepted term used to describe the broad spectrum of genitourinary tract symptoms and signs caused by the loss of endogenous sex steroids that occurs at the time of and after the menopause. Global improvements in healthcare have resulted in an ageing population. Today, women are spending 40% of their lives in the postmenopausal state, and with 50-70% of postmenopausal women reporting symptomatic GSM, safe and efficacious treatments are needed for this troublesome condition. This article reviews current evidence for non-pharmacological and pharmacological treatments with a focus on novel and minimally invasive procedures such as energy-based devices (CO laser, YAG laser), hyaluronic acid, dehydroepiandrosterone, and selective oestrogen receptor modulators.
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http://dx.doi.org/10.12703/r/10-25DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7946389PMC
March 2021

Pharmacist's knowledge regarding the management of overactive bladder in elderly women.

Eur J Obstet Gynecol Reprod Biol 2021 Mar 16;258:269-272. Epub 2021 Jan 16.

Department of Urogynaecology, King's College Hospital, London, UK.

Objective: Anticholinergic drugs are the mainstay treatment of OAB. Anticholinergic load is the cumulative effect of taking anticholinergic medication. Recent evidence suggests that in the elderly this can have a detrimental affect, with the potential to develop dementia. A previous study found that knowledge of anticholinergic load was lacking in our healthcare professionals. The aim of this study was to assess knowledge of pharmacists, who in the UK have the potential where qualified to prescribe as well as dispense.

Study Design: A questionnaire was formulated based on the previous study. It was sent out to 418 pharmacists from; a south London hospital trust, a south London clinical commissioning group and United Kingdom Clinical Pharmacists Association.

Results: Seventy-five pharmacists completed the questionnaire. Solifenacin and tolterodine was the most popular drug prescribed in the elderly without dementia, whilst mirabegron was the most popular in the elderly with dementia. One pharmacist suggested using oxybutynin. Sixty-two percent discuss anticholinergic load with the patients, 40 % advice prescribers and 42 % consider anticholinergic load when dispensing the drug. Fifteen percent have had patients report confusion/memory loss. Thirty percent know how to assess anticholinergic load. Only 15 % felt dementia was a concern with anticholinergic drugs. Worryingly, 54 % though mirabegron exerted anticholinergic effects.

Conclusion: This is the first study looking at pharmacist knowledge on the use of anticholinergic medication for OAB in elderly women. Knowledge amongst all healthcare professionals including pharmacists is lacking and needs to be improved.
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http://dx.doi.org/10.1016/j.ejogrb.2021.01.021DOI Listing
March 2021

Urethral bulking agent found in a urethral caruncle which did not respond to topical oestrogens: A case report.

Case Rep Womens Health 2020 Oct 27;28:e00268. Epub 2020 Oct 27.

Department of Urogynaecology, Suite 8, Golden Jubilee Wing, King's College Hospital, SE5 9RS, UK.

Background: Urethral caruncles are lesions occurring at the urethral orifice, around the posterior lip of the urethra. They are the most common benign growth of the female urethra. They are often asymptomatic and found incidentally on clinical examination. When symptomatic they commonly present with bleeding. Treatment includes vaginal oestrogens or, failing that, surgical excision. We present an unusual finding after excision of a urethral caruncle.

Case: A patient with a background of stress urinary incontinence had numerous pelvic surgeries, including colposuspension, tension-free vaginal tape (TVT) and Macroplastique (a urethral bulking agent). She developed bleeding from a 3 cm urethral caruncle, which did not improve with vaginal oestrogens. She proceeded to have a surgical excision of the caruncle. Histology revealed a foreign material with surrounding foreign-body-type multinucleate giant cell reaction. The material was compatible with Macroplastique.

Conclusion: This case report describes an unusual and unexpected histological finding. Macroplastique is injected in the urethra, 10-15 mm from the bladder neck. We suspect the caruncle dragged the Macroplastique material out through the urethral meatus. If urethral caruncles are not adequately treated with vaginal oestrogens, surgery should be considered.
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http://dx.doi.org/10.1016/j.crwh.2020.e00268DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609486PMC
October 2020

Defining nocturnal polyuria in women.

Neurourol Urodyn 2021 01 21;40(1):265-271. Epub 2020 Oct 21.

Birmingham Women's Hospital, Birmingham, England.

Aims: Nocturnal polyuria (NP) is defined by the International Continence Society (ICS) as "excessive production of urine during the main sleep period" and is one of the main causes of nocturia. The ICS recognized that "excessive" is not clearly defined and that this needs to be highlighted in both clinical and research settings. The aim of this study was to identify different definitions of NP and apply them to a population of women attending the Urogynaecology clinic.

Methods: This was a retrospective study of complete bladder diaries collected from women attending a tertiary Urogynaecology Unit. Six different definitions were identified and were divided into "absolute," "relative," and "functional definitions." Prevalence data were calculated and values generated for sensitivity, specificity, positive and negative predictive values when related to women voiding ≥ 2 times per night.

Results: Complete bladder diaries were obtained from 1398 women, over 6 years, with a mean age of 57 years. Prevalence varied across the definitions from 21.5% (absolute definition) to 77% (relative definition). Sensitivity ranged from 43% (absolute) to 87% (relative). The definitions that showed the highest combined sensitivity and specificity were the functional definitions.

Conclusion: From this study it is clear that more work needs to be done to arrive at a consensus for defining NP to enable accurate diagnosis and development of treatment pathways. We propose that a relative definition may provide a more clinically relevant method of defining NP.
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http://dx.doi.org/10.1002/nau.24546DOI Listing
January 2021

Practice observed in managing gynaecological problems in post-menopausal women during the COVID-19 pandemic.

Post Reprod Health 2020 Dec 30;26(4):227-228. Epub 2020 Sep 30.

King's College Hospital, King's College Hospital NHS Foundation Trust, London, UK.

The way in which gynaecology services are provided in the UK has drastically changed within a short space of time due to the global COVID-19 pandemic. Gynaecologists are not considered front-line staff in the treatment of the novel coronavirus unlike our intensive care or accident and emergency colleagues. However, the impact this is having on those with chronic problems is significant, and the morbidity associated with missed malignancies could be problematic. This article summarises the strategies developed at King's College Hospital to remodel services to best provide optimum treatment to patients in this new era.
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http://dx.doi.org/10.1177/2053369120957540DOI Listing
December 2020

Recent advances in managing overactive bladder.

F1000Res 2020 11;9. Epub 2020 Sep 11.

Department of Urogynaecology, King's College Hospital, London, UK.

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection or other obvious pathology. In this review, we focus on recent advances in the management of OAB. We examine the evidence on the effect of anticholinergic load on OAB patients. Advances in medical treatment include a new beta-3 agonist, vibegron, which is thought to have fewer drug interactions than mirabegron. Treatment of genitourinary syndrome of the menopause with oestrogens and ospemifene have also shown promise for OAB. Botulinum toxin has been shown to be an effective treatment option. We discuss the new implantable neuromodulators that are on the market as well as selective bladder denervation and laser technology.
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http://dx.doi.org/10.12688/f1000research.26607.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489273PMC
February 2021

An unusual late complication with tension-free vaginal tape (TVT): A case report.

Case Rep Womens Health 2020 Oct 25;28:e00252. Epub 2020 Aug 25.

Department of Urogynaecology, Suite 8, Golden Jubilee Wing, King's College Hospital, London SE5 9RS, UK.

Background: Stress urinary incontinence is a common problem affecting women's quality of life. The retropubic mid-urethral sling accounts for the majority of surgical interventions for stress incontinence. Complications of the procedure are rare. We present an unusual late complication with tension-free vaginal tape (TVT).

Case: Two years after insertion of a TVT for stress incontinence, a patient noticed a foreign body intermittently exiting through her anus. Initial clinical examinations and investigations were unremarkable. Five years after insertion she represented with faecal matter in the vagina and a TVT erosion. Imaging confirmed a colo-vaginal fistula. She underwent a vaginal excision of the TVT but this did not cure her problem and she subsequently had a laparoscopic sigmoid colectomy. Thereafter she remained well and asymptomatic.

Conclusion: This case report describes an unusual late complication. It is likely that the left arm of the mesh entered the serosa of the sigmoid colon and eroded into it over time. Complications associated with TVT are rare, but when they occur they need to be recorded. Only surgeons who have experience and expertise in the procedure should perform it, such as subspecialty trained urogynaecologists.
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http://dx.doi.org/10.1016/j.crwh.2020.e00252DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7479271PMC
October 2020

Cognitive Effects of Anticholinergic Load in Women with Overactive Bladder.

Clin Interv Aging 2020 25;15:1493-1503. Epub 2020 Aug 25.

Urogynaecology Department, King's College Hospital, London, UK.

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection or other obvious pathology. The mainstay of treatment of OAB is anticholinergic/antimuscarinic medication. These drugs block muscarinic receptors throughout the body, not only the bladder, including in the brain, which may lead to cognitive side effects. Anticholinergic load or burden is the cumulative effect of taking drugs that are capable of producing anticholinergic adverse effects. The elderly are more susceptible to these effects, especially as there is increased permeability of the blood brain barrier. The anticholinergic drugs for OAB are able to enter the central nervous system and lead to central side effects. There is increasing evidence that a high anticholinergic load is linked to the development of cognitive impairment and even dementia. Some studies have found an increased risk of mortality. In view of this, care is needed when treating OAB in the elderly. Trospium chloride is a quaternary amine anticholinergic, which has a molecular structure, which theoretically means it is less likely to cross the blood brain barrier and exert central side effects. Alternatively, mirabegron can be used, which is a beta-3 adrenoceptor agonist, which does not add to the anticholinergic load or exert central nervous system side effects. Conservative therapy can be used as an alternative to pharmacological treatment in the form of behavioral modification, fluid management and bladder retraining. Neuromodulation or the use of botox can also be alternatives, but success may be less in the older adult and will require increased hospital attendances.
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http://dx.doi.org/10.2147/CIA.S252852DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7457731PMC
December 2020

Sacral nerve stimulation for refractory OAB and idiopathic urinary retention: Can phenotyping improve the outcome for patients: ICI-RS 2019?

Neurourol Urodyn 2020 07;39 Suppl 3:S96-S103

School of Physiology, Pharmacology, and Neuroscience, University of Bristol, Bristol, UK.

Aims: Sacral nerve stimulation (SNS) is widely used to treat refractory idiopathic overactive bladder (OAB) and idiopathic urinary retention. However, clinical outcomes are variable and understanding predictive factors for success or side-effects would enable personalization of therapy and optimization of outcomes. At the International Consultation on Incontinence-Research Society meeting 2019, a Think Tank was convened to discuss how advances in the basic science study of SNS may be translatable into clinical practice to improve outcomes of patients undergoing SNS treatment.

Methods: We conducted a literature review and expert consensus meeting focusing on current methods of phenotyping patients and specifically, how advances in basic science research of the mechanism of action of SNS can be translated into clinical practice to improve patient selection for therapy.

Results: The terms "Idiopathic OAB" and "idiopathic urinary retention" encompass several underlying pathophysiological phenotypes. Commonly, phenotyping is based on clinical and urodynamic factors. Animal studies have demonstrated that high-frequency stimulation can produce rapid onset, reversible conduction block in peripheral nerves. Altering stimulation parameters may potentially enable personalization of therapy depending upon the clinical indication in the future. Similarly, advances in conditional and closed-loop stimulation may offer greater efficacy for certain patients. Phenotyping based on psychological comorbidity requires further study to potentially optimize patient selection for therapy.

Conclusions: Idiopathic OAB and idiopathic urinary retention are heterogenous conditions with multiple potential underlying phenotypes. Tailoring stimulation parameters to the needs of each individual according to phenotype could optimize outcomes. Assessing psychological comorbidity may improve patient selection. Areas for further research are proposed.
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http://dx.doi.org/10.1002/nau.24204DOI Listing
July 2020

Should we routinely assess psychological morbidities in idiopathic lower urinary tract dysfunction: ICI-RS 2019?

Neurourol Urodyn 2020 07;39 Suppl 3:S70-S79

Department of Child and Adolescent Psychiatry, Saarland University Hospital, Homburg, Germany.

Aims: Psychological morbidities play a major role in idiopathic lower urinary tract dysfunction (iLUTD). The aim of the Think Tank (TT) was to discuss the relevance of psychological morbidities in idiopathic LUTD over the life span, including overactive bladder (OAB) or dysfunctional voiding (DV) and methods of assessment.

Methods: The paper is based on a selective review of the literature and in-depth discussions, leading to research recommendations regarding the assessment of psychological morbidities in iLUTD on children and adults held during the TT of the International Consultation on Incontinence Research Society in 2019.

Results: Psychological comorbidities affect the health behaviors and treatment outcomes in patients with iLUTD. Both clinically relevant comorbid mental disorders, as well as subclinical psychological symptoms have a major impact and negatively influence incontinence treatment. Research is needed to elucidate mechanisms underlying iLUTD and psychological comorbidities. Clinical studies are needed to determine how perception generation and cognition impacts on the relationship of urinary perceptions, symptoms, and objective urodynamic function. Due to high psychological comorbidity rates, screening with validated, generic questionnaires for emotional and behavioral disorders in children with nocturnal enuresis, daytime urinary incontinence, and fecal incontinence is recommended. Brief screening is recommended for all adults with iLUTD, especially with OAB and DV, who are refractory to treatment.

Conclusions: Due to the high rate and relevance in clinical practice, screening for psychological comorbidities is recommended for all age groups. The research recommendations of this TT may be followed to improve the assessment of psychological morbidities in iLUTD.
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http://dx.doi.org/10.1002/nau.24361DOI Listing
July 2020

Ninth International Consultation on Incontinence-Research Society 2019: Introduction.

Neurourol Urodyn 2020 07;39 Suppl 3:S7-S8

Division of Urology, University of Pennsylvania Health System, Philadelphia, Pennsylvania.

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http://dx.doi.org/10.1002/nau.24435DOI Listing
July 2020

Recent advances in urodynamics in women.

F1000Res 2020 15;9. Epub 2020 Jun 15.

Department of Urogynaecology, King's College Hospital, London, UK.

Urodynamics is the study of the storage and evacuation of urine from the urinary tract. The aim is to reproduce the patient's symptoms and provide a pathophysiological explanation for them by identifying all factors that contribute to the lower urinary tract dysfunction, including those that are asymptomatic. Urodynamics consists of various tests, each of which is designed to assess a different aspect of lower urinary tract function. There is a lack of evidence regarding when urodynamics should be used in the non-neurogenic bladder. Some small randomised controlled trials suggest that urodynamics does not alter the outcome of surgery for stress urinary incontinence when compared with office evaluation alone. However, this is widely felt to be inaccurate and many health-care professionals still advocate the use of urodynamics prior to any invasive treatment, especially surgery on the lower urinary tract. There have been few technological advances in urodynamics in recent years. Air-charged rather than fluid-filled catheters were thought to help reduce artefact, but the evidence is unclear, and there is doubt over their accuracy. Ambulatory urodynamics is carried out over a longer period of time, enabling physiological bladder filling, but it remains invasive and artificial. To attempt to replicate symptoms more accurately, there have been efforts to develop wireless devices to measure detrusor pressure directly. These may be promising but are far from suitable in humans at present. Urodynamics continues to provide useful information for assessing lower urinary tract function, but further large studies are required to assess its value and develop innovations to improve the accuracy of the tests and acceptability to patients.
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http://dx.doi.org/10.12688/f1000research.24640.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308832PMC
October 2020

Lasers in gynaecology.

Eur J Obstet Gynecol Reprod Biol 2020 Aug 19;251:146-155. Epub 2020 May 19.

Consultant Gynaecologist and Urogynaecologist, Kings College Hospital, UK.

The use of lasers to treat gynaecological and urogynaecological conditions including genitourinary syndrome of the menopause, stress urinary incontinence, vaginal prolapse and other conditions, has become increasingly popular over recent years. Following widespread concerns over the use of mesh for treating stress urinary incontinence and pelvic organ prolapse and potential adverse outcomes from the use of mesh, there has been heightened awareness and debate over the introduction and adoption of new technologies and interventions within the speciality. On July 30th 2018 the United States Food and Drug Administration (FDA) issued a warning against the use of energy based devices (EBDS) including laser to perform "vaginal rejuvenation" or vaginal cosmetic procedures. Numerous review articles and editorials have urged for greater evidence on the efficacy and safety of vaginal lasers This review outlines the evidence to date for the use of lasers in the treatment of gynaecological conditions.
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http://dx.doi.org/10.1016/j.ejogrb.2020.03.034DOI Listing
August 2020

Can we harness the placebo effect to improve care in lower urinary tract dysfunction? ICI-RS 2019.

Neurourol Urodyn 2020 07 20;39 Suppl 3:S80-S87. Epub 2020 Apr 20.

Department of Urology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.

The proposal "Can we harness the placebo effect to improve care in lower urinary tract dysfunction?" was discussed at the International Consultation on Incontinence-Research Society (ICI-RS) 2019 meeting. The placebo effect can change the treatment outcome whether the treatment is an active treatment or placebo. The total active treatment outcome is a combination of the placebo and the active treatment effect which is seen in placebo-controlled trials. The placebo effect plays an important role in the treatment of lower urinary tract dysfunction in overactive bladder, bladder pain syndrome, and stress urinary incontinence. In clinical practice, a number of factors can be employed to use the placebo effect to maximize its effect on patients receiving an active treatment, such as having the same environment for review such as the same appointment time, same room, and same clinician. Clinicians should also be aware of the nocebo effect which is increased with an overemphasis on side effects or negative outcomes.
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http://dx.doi.org/10.1002/nau.24351DOI Listing
July 2020

Antibiotic resistance in urinary tract infections: A re-visit after five years and experience over two sites.

Post Reprod Health 2020 Jun 6;26(2):91-100. Epub 2020 Apr 6.

Department of Urogynaecology, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.

Objective: The aim of this study was to repeat a previous audit, performed from 2009 to 2013, for the cohort of 2018 to determine how the resistance rates in urinary pathogens in women over 18 years of age have changed. A secondary aim of the study was to use resistance data from a different UK hospital in the same year to compare differences in resistance rates across different geographic locations.

Study Design: This was a retrospective study of all positive urine cultures grown from female patients attending two different hospitals in the year 2018. Resistance patterns were analysed.

Results: The resistance rate to co-amoxiclav continues to increase with amoxicillin retaining high resistance patterns. There are some significant differences in resistance patterns between the different locations.

Conclusion: Antimicrobial resistance is a significant problem in the UK particularly in antibiotics used to treat UTI. These patterns can vary across different geographical locations and over time; therefore, up-to-date knowledge of local anti-biotic resistance is essential when making an appropriate prescription choice.
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http://dx.doi.org/10.1177/2053369120910039DOI Listing
June 2020

Social media awareness among non-urogynecologists regarding the current mesh discussions in urogynecology: a survey study.

Int Urogynecol J 2020 06 17;31(6):1231-1243. Epub 2020 Feb 17.

Department of Urogynecology, King's College Hospital, London, UK.

Introduction And Hypothesis: There has been a great deal of discussion about mesh complications in urogynecology in recent years. However, awareness of other doctors who are not urogynecologists is unknown. This study was aimed at determining the level of awareness of mesh discussions among medical doctors whose specialty is not urology or gynecology.

Methods: A survey study was administered, and all medical doctors, except gynecologists and urologists, were invited. Respondent doctors were classified into four groups: King's College Hospital (KCH), UK; Uludag University Hospital (UUH), Turkey; the United States (USA); and the world (WORLD). The primary outcome was the awareness of mesh discussion in urogynecology, and the secondary outcome was the social media awareness of the mesh discussion.

Results: 1231 doctors responded to the survey. The awareness of the current mesh problems among the respondent doctors was 15.8% in KCH, 15.4% in UUH, 26.9% in the USA, and 16.2% in WORLD. The social media awareness about mesh problems was 20.8% in KCH, 20.3% in UUH, 32.8% in the USA, and 20.6% in WORLD. Although there were no differences among three of the groups with regard to primary and secondary outcomes, the USA group score was statistically significantly higher than the others.

Conclusions: Social media can influence doctors' thinking on controversial academic issues. In this survey study, non-urogynecologist doctors in the USA cohort have higher awareness levels and a higher social media awareness level than other groups.
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http://dx.doi.org/10.1007/s00192-020-04242-3DOI Listing
June 2020

Is there enough evidence to justify the use of laser and other thermal therapies in female lower urinary tract dysfunction? Report from the ICI-RS 2019.

Neurourol Urodyn 2020 07 10;39 Suppl 3:S140-S147. Epub 2020 Feb 10.

Department of Urogynaecology, Kings College Hospital, London, UK.

Aims: There is increasing evidence to suggest that thermomodulation may have a role in the management of women with lower urinary tract dysfunction (LUTD) and there has been widespread adoption of laser and radiofrequency (RF) therapies within clinical practice. However, in many areas of LUTD, the data are still limited and there remains a need for further evaluation of the safety and efficacy of thermal therapy. The aim of this study proposal is to report the findings of the International Consultation on Incontinence Research Society to clarify our current knowledge regarding the evidence for thermal therapy in LUTD and to set research priorities for the future.

Methods: Literature review based on the search terms: "laser," "radiofrequency," "genitourinary syndrome of the menopause" or "urogenital atrophy," "stress urinary incontinence (SUI)," "pelvic organ prolapse," "OAB" or "overactive bladder," and "urinary tract infection."

Results: The current available evidence, though of low or very low quality, appears promising for the use of laser therapy in the management of genitourinary syndrome of the menopause, there are some data to suggest a possible role in SUI although very little evidence for urogenital prolapse. At present, the evidence supporting the use of laser in OAB and recurrent urinary tract infection is limited or lacking, while the available evidence for RF in the management of all forms of LUTD is much less robust.

Conclusions: Laser and RF are being introduced clinically as a minimally invasive, low-risk interventions for women with LUTD although at present, the evidence supporting usage is limited. Consequently, there is an urgent need to demonstrate the safety and efficacy with prospective long-term studies including sham studies and comparative studies with current standard therapy.
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http://dx.doi.org/10.1002/nau.24298DOI Listing
July 2020

Do we have adequate data to construct a valid algorithm for management of synthetic midurethral sling complications? ICI-RS 2019.

Neurourol Urodyn 2020 07 5;39 Suppl 3:S122-S131. Epub 2020 Feb 5.

Department of Urology, Freeman Hospital, Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, UK.

Background: Synthetic midurethral sling (MUS) procedures, purported for the last two decades as the gold standard surgical treatment for stress urinary incontinence, have been in creasingly scrutinized in recent years with regard to the rate and severity of complications.

Methods: During the International Consultation on Incontinence Research Society meeting held in Bristol, UK, in 2019, a multidisciplinary panel held a think tank and discussed the contemporary evidence pertaining to the classification, investigation, and treatment of MUS complications.

Results: The current classification system of mesh-related complications was discussed, and shortcomings were identified. The lack of a standardized clinical pathway was noted, and the value of clinical investigations and surgical treatments was difficult to fully evaluate. The paucity of high-level evidence was a common factor in all discussions, and the difficulties with setting up relevant randomized-controlled trials were highlighted.

Conclusions: The outcome of the think-tank discussions is summarized with a set of recommendations designed to stimulate future research.
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http://dx.doi.org/10.1002/nau.24299DOI Listing
July 2020

What affects the placebo effect?

Eur J Obstet Gynecol Reprod Biol 2020 Mar 22;246:134-137. Epub 2020 Jan 22.

King's College Hospital, Denmark Hill, London, SE5 9RS, UK.

Objective: To determine whether electronic bladder diaries are associated with a larger placebo effect than paper diaries in studies of overactive bladder (OAB). To identify any other factors in study design that may influence the placebo effect.

Study Design: This is a secondary analysis of a previous systematic review and network meta-analysis on the efficacy and tolerability of mirabegron. Each study was analysed and placebo response rate (PRR) was calculated. Statistical analysis was used to look for associations with different factors and PRR.

Results: The PRR was considerable in the studies analysed (10.5 % when calculated for change in number of micturitions over 24 h and 41.2 % for change in urgency urinary incontinence episodes over 24 h). Paper bladder diaries were associated with a significantly larger placebo response rate than electronic (10.76 % vs 10.22 %), although this may be clinically small. The size of study had a moderate positive correlation with PRR. Length of bladder diary was not associated with increased PRR.

Conclusions: The PRR in studies of OAB is varied and significant. It is clear that it can be affected by factors in study design including type of bladder diary. When designing clinical studies this should be borne in mind. Equally, when attempting to optimise patient care, the benefit of the therapeutic encounter should be remembered.
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http://dx.doi.org/10.1016/j.ejogrb.2020.01.023DOI Listing
March 2020

Can multicentre urodynamic studies provide high quality evidence for the clinical effectiveness of urodynamics? ICI-RS 2019.

Neurourol Urodyn 2020 07 21;39 Suppl 3:S30-S35. Epub 2020 Jan 21.

Department of Experimental Medicine and Surgery, Department of Surgery, Policlinico Tor Vergata, University of Rome "Tor Vergata" and Urology Unit, Rome, Italy.

Aims: Lower urinary tract (LUT) function can be investigated by urodynamic studies (UDS) to establish underlying functional abnormalities in the LUT. A multicentre registry could present an opportunity to improve the scientific evidence base for UDS. During the International Consultation on Incontinence Research Society (ICI-RS) meeting in Bristol, United Kingdom 2019, an expert panel discussed the potential of a multicentre urodynamic registry to improve the quality of urodynamic output.

Methods: the potential importance of a multicentre urodynamic registry, parameter inclusion, quality control, and pitfalls during a registry roll-out were reviewed and discussed.

Results And Conclusions: The clinical utility, evaluation, and effectiveness of UDS remain poorly defined due to a lack of high quality evidence and large study populations. Therefore, the ICI-RS proposes formation of a urodynamic panel for future roll-out of a registry. The inclusion of basic parameters was discussed and the essential parameters were defined as well as the potential pitfalls of a registry roll-out. The discussion and recommendations in this paper form the base for future urodynamic registry development.
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http://dx.doi.org/10.1002/nau.24280DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497217PMC
July 2020

Can we improve our diagnosis of impaired detrusor contractility in women? An ICI-RS 2019 proposal.

Neurourol Urodyn 2020 07 19;39 Suppl 3:S43-S49. Epub 2019 Dec 19.

Bristol Urological Institute, Southmead Hospital, Bristol, UK.

Introduction: Widely accepted consensus terminology and calculations of detrusor contractility in females do not exist but may be useful. We report the output of a proposal session at the International Consultation on Incontinence Research Society meeting 2019, addressing the title topic.

Methods: Three formal presentations and a lively discussion addressed several questions including: which is the optimal cutoff value of female bladder voiding efficiency during uroflow to suspect obstruction or detrusor underactivity? Is there a definition of pure underactive and pure obstructed voiding in females? Is there a place to distinguish those relatively obstructed from those relatively underactive females especially in those cases of equivocal obstruction? Current measures of contractility were reviewed for their usefulness in women.

Results: No recommendation for a specific index or calculation can be made based on current knowledge. "Contractility" may be context-dependent regarding clinical care, clinical prognostication, and physiologic research.

Conclusions: This group proposes that context-sensitive definitions of "Contractility" deserve attention by international leadership. Cooperative clinical and physiologic expertise will be needed to achieve this goal. Following initial recommendations based on expert opinion, the development of final definitions and measures of contractility should be iterative, based upon validation studies to be considered as part of the definitional process.
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http://dx.doi.org/10.1002/nau.24260DOI Listing
July 2020

Recommendations and future research initiative to optimize bladder management in pregnancy and childbirth International Consultation on Incontinence - Research society 2018.

Neurourol Urodyn 2019 12;38 Suppl 5:S104-S110

Department of Urogynaecology, King's College Hospital, London, UK.

With increasing birth rates globally, obstetric bladder care and long term pelvic floor dysfunction continues to be a issue. This paper aims to provide an overview of the concerns in the antenatal, intrapartum an post partum periods and presents recommendation for the research requirements necessary and education to challenge current practice.
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http://dx.doi.org/10.1002/nau.24053DOI Listing
December 2019

Do we need better information to advise women with stress incontinence on their choice of surgery? Report from the ICI-RS 2018.

Neurourol Urodyn 2019 12;38 Suppl 5:S98-S103

Department of Urogynaecology, King's College Hospital, London, UK.

Aims: The regulatory warnings about the safety of the synthetic midurethral slings (MUS) had a significant effect on how patients and physicians approach surgical management of stress urinary incontinence (SUI). In this changing landscape, the purpose of this research Think Tank (TT) was to provide an update of the current knowledge about the safety and efficacy of SUI surgery, to review patient goals and expectations and to identify factors affecting the decision making for surgery.

Methods: This is a consensus report of the proceedings of TT3: "Do we need better information to advise women with stress incontinence on their choice of surgery?" from the annual International Consultation on Incontinence-Research Society (ICI-RS), June 2018.

Results: Despite the body of evidence supporting the continued use of MUS, the short follow-up of most of the studies and the lack of "real life" data regarding pain and sexual dysfunction make the development of recommendations challenging. Women with SUI are often happy to "trade" efficacy for a procedure with less associated morbidity and therefore it is not always the procedure with the highest success rate that is ultimately chosen. However, a number of factors influence treatment decision and there is limited evidence about what level of all these factors women are willing to tolerate for a given success rate, or how much success they are willing to trade for a lower complication rate.

Conclusions: The ICI-RS proposed research questions which may be able to assist in improving the counseling and management of women with SUI.
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http://dx.doi.org/10.1002/nau.24020DOI Listing
December 2019

Exploring the relation between obesity and urinary incontinence: Pathophysiology, clinical implications, and the effect of weight reduction, ICI-RS 2018.

Neurourol Urodyn 2019 12;38 Suppl 5:S18-S24

Department of Urogynaecology, King's College Hospital, London, UK.

Aims: To evaluate the relationship between obesity and urinary incontinence (UI) and to determine the effect of weight reduction on the severity of incontinence.

Methods: This is a consensus report of the proceedings of a Research Proposal from the annual International Consultation on Incontinence-Research Society, 14 June to 16 June, 2018 (Bristol, UK): "What are the relationships between obesity and UI, and the effects of successful bariatric surgery?"

Results: Obesity is an increasing problem worldwide and is associated with many adverse effects on health and quality of life. From both translational and clinical studies, there is a strong relationship between obesity and the occurrence of UI. Both mechanical and metabolic factors seem to play an important role including systemic inflammation and oxidative stress due to the release of cytokines in visceral adipose tissue. The success rate of anti-incontinence surgery does not seem to be greatly affected by body mass index (BMI), although reliable data and long-term follow-up are currently lacking. Both weight reduction programs and bariatric surgery can result in amelioration of UI. Various studies have shown that weight loss (particularly that associated with bariatric surgery) can reduce incontinence, and the degree of weight loss is positively correlated with improvement in symptoms.

Conclusions: Obesity is strongly associated with an increased prevalence of both stress and urgency UI. The treatment outcome does not seem to be highly dependent on BMI. Weight reduction is positively correlated with improvement of incontinence symptoms and therefore should be advocated in the management.
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http://dx.doi.org/10.1002/nau.24072DOI Listing
December 2019

How can we improve investigation, prevention and treatment for recurrent urinary tract infections - ICI-RS 2018.

Neurourol Urodyn 2019 12;38 Suppl 5:S90-S97

Southmead Hospital, Bristol Urological Institute, Bristol, UK.

Background: Recurrent urinary tract infection (rUTI) is a chronic condition and has a significant impact on health-related quality of life. The commonly used definition for rUTI is greater than three episodes in a year or more than two in 6 months. Current diagnostic methods have been used worldwide for over five decades, despite well evidenced criticism. Enhanced culture techniques demonstrate that the microbiome of the bladder is far more complex than previously thought and begs a reappraisal of our current testing. Treatment of rUTI is based on a small number of antibiotic trials with some evidence showing a reduction in the number of positive cultures, but one must be cautious in interpreting the results and weigh against the risk of generation of antimicrobial resistance (AMR).

Aim: The International Consultation on Incontinence-Research Society think tank reviewed the literature with a view to improving investigation, prevention and treatment of rUTI.

Methods: A multidisciplinary team of experts were invited to present evidence regarding the current diagnostic methods, recent advances related to bladder biome mapping and current treatment strategies, including antibiotic and nonantibiotic options. Current guidelines regarding antibiotic stewardship and concerns regarding AMR were discussed.

Discussion: Outcome of the think tank discussions are summarised with a set of recommendations to inform future research. Particular consideration is given to bacterial survival in the bladder after treatment as well as defects in urothelial barrier function which may play a significant part in the failure to eradicate UTI.
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http://dx.doi.org/10.1002/nau.24021DOI Listing
December 2019

Botulinum toxin A for refractory OAB and idiopathic urinary retention: Can phenotyping improve outcome for patients: ICI-RS 2019?

Neurourol Urodyn 2020 07 6;39 Suppl 3:S104-S112. Epub 2019 Nov 6.

School of Physiology, Pharmacology and Neuroscience, University of Bristol, Bristol, UK.

Aims: Botulinum toxin A (BTX-A) is a well-established treatment for refractory idiopathic overactive bladder (OAB). It has also been used with short-term success in treating idiopathic urinary retention. However, efficacy and complication rates are variable and predicting those likely to benefit most from treatment would enable personalization of therapy and optimization of outcomes. At the International Consultation on Incontinence-Research Society (ICI-RS) meeting in 2019 a Think Tank addressed the question of how we can improve the way we phenotype patients undergoing BTX-A treatment.

Methods: The Think Tank conducted a literature review and expert consensus meeting focussing on how advances in basic science research of the mechanism of action of BTX-A, as well as assessment of psychological comorbidity, can be translated into clinical practice to improve patient selection for therapy.

Results: Idiopathic OAB and idiopathic urinary retention are heterogenous conditions encompassing several phenotypes with multiple potential pathophysiological mechanisms. Animal models have demonstrated a central nervous system mechanism of action of intravesically injected BTX-A and this has been confirmed in human functional MRI studies, but whether this tool can be used to predict outcome from treatment remains to be determined. Phenotyping based on psychological comorbidity using validated screening tools should be studied as a way to potentially optimize patient selection for therapy.

Conclusions: Advances in basic science research into the mechanism of action of BTX-A have improved our understanding of the pathophysiology of OAB and may lead to novel ways to phenotype patients. Psychological assessment is another way in which phenotyping may be improved. Areas for further research are proposed.
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http://dx.doi.org/10.1002/nau.24207DOI Listing
July 2020

Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo.

Eur Urol 2020 01 18;77(1):119-128. Epub 2019 Oct 18.

Department of Global Medical Affairs, Astellas Pharma, Chertsey, UK.

Background: Mirabegron, a β3-adrenoreceptor agonist, is an alternative drug to antimuscarinics for overactive bladder (OAB) symptoms.

Objective: To summarise safety and efficacy reporting of mirabegron treatment for OAB symptoms.

Design, Setting, And Participants: Pooled data analysed from 10 phase 2-4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug.

Intervention: Mirabegron: 25 and 50mg; antimuscarinics: solifenacin (2.5, 5, and 10mg) and tolterodine extended release (4mg).

Outcome Measurements And Statistical Analysis: Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age (<65 vs ≥65yr and <75 vs ≥75yr) and sex were assessed. Solifenacin 2.5 and 10mg groups were not included in the efficacy analyses (small patient numbers). Safety was evaluated using the proportion of treatment-emergent adverse events. Efficacy variables were derived from bladder diaries (baseline and week 12).

Results And Limitations: Baseline hypertension and diabetes were more frequent across treatment groups in the older versus younger age groups and in men versus women. Within sexes, frequencies were similar between treatment groups. Some differences were observed in baseline characteristics, including type of incontinence and medical history between sexes. No previously unreported safety concerns were identified. Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups. Significant treatment-by-subgroup interactions included change from baseline in the mean number of incontinence episodes/24h by age (<65 vs ≥65yr), nocturia by age (<65 vs ≥65yr and <75 vs ≥75yr), and urgency episodes by previous OAB medication.

Conclusions: Data from this integrated database of 10 mirabegron studies reaffirm the safety and efficacy profiles of mirabegron, solifenacin, and tolterodine in adults of different age groups and sexes.

Patient Summary: Overactive bladder is a complex of symptoms including a compelling desire to pass urine that leads to increased frequency, which may lead to a degree of incontinence if you do not reach the toilet in time and may wake you from sleep. We pooled data from 10 different studies of mirabegron in patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women. No new safety concerns were identified, and mirabegron improved the symptoms of overactive bladder.
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http://dx.doi.org/10.1016/j.eururo.2019.09.024DOI Listing
January 2020

External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial.

Neurourol Urodyn 2019 09 3;38(7):1834-1843. Epub 2019 Jul 3.

Department of Urogynaecology, King's College Hospital, London, United Kingdom.

Aims: To compare the efficacy and safety of a neuromuscular external electrical stimulation device (INNOVO; "NMES") with an FDA-approved intravaginal device (iTouch sure; "comparator device") for the treatment of stress urinary incontinence (SUI).

Methods: This prospective, single-blind, multicenter, noninferiority study randomized women with SUI to treatment with the NMES or the comparator device for 12 weeks. The primary endpoint was the proportion achieving >50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test.

Results: Most subjects in both groups achieved >50% reduction in pad weight in the provocative pad test at week 12 (NMES 56.3%; comparator 63.0%), although noninferiority was not established. Significant improvements in pad tests, number of incontinence episodes, and pads used per day, and incontinence quality of life score were seen with both devices at week 12, with no clinically relevant between-group differences. Adverse events were predominantly mild/moderate and there were few discontinuations due to adverse events. The incidence of urinary tract/vaginal infections was higher with the comparator device than the NMES (7.7% versus 0%). The most common device-related adverse effect with the NMES was device discomfort (9.0%), which was generally manageable by modifying the stimulation intensity.

Conclusions: The NMES significantly improved objective and subjective measures of SUI, although statistical noninferiority was not established. The NMES was well tolerated and associated with fewer urinary tract infections than the comparator. The NMES provides a safe, clinically effective, conservative treatment option for female SUI and a low-risk alternative to intravaginal devices.
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http://dx.doi.org/10.1002/nau.24066DOI Listing
September 2019
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