Publications by authors named "Elisabeth Farrelly"

7 Publications

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OnabotulinumtoxinA is a well tolerated and effective treatment for refractory overactive bladder in real-world practice.

Int Urogynecol J 2021 Jan 27;32(1):65-74. Epub 2020 Jul 27.

Södersjukhuset, Stockholm South General Hospital, Stockholm, Sweden.

Introduction And Hypothesis: In randomized clinical trials onabotulinumtoxinA was demonstrated to be an effective and well-tolerated treatment for overactive bladder (OAB) with urinary incontinence (UI). However, data reporting onabotulinumtoxinA use in everyday clinical practice are limited. Here, we present the results from a large, first-of-its-kind real-world study in patients with OAB.

Methods: This was a prospective, observational, multinational study (GRACE; ClinicalTrials.gov , NCT02161159) performed in four European countries. Patients (N = 504) aged ≥ 18 years with OAB inadequately managed with ≥ 1 anticholinergic received onabotulinumtoxinA per their physician's normal clinical practice.

Results: Physicians primarily used rigid cystoscopes for onabotulinumtoxinA injection; anesthesia/analgesia was utilized during most treatment procedures. Significant reductions in UI episodes/day from baseline to weeks 1 and 12 were observed as well as in micturition, urgency, and nocturia episodes/day. These improvements in urinary symptoms corresponded to higher scores on the treatment benefit scale at week 12. The use of other OAB medications dropped from baseline to weeks 1 and 12 and was sustained to week 52, which paralleled a reduction in the number of incontinence products used during that time frame. Adverse reactions were reported in 2.6% of patients throughout the study.

Conclusions: In this real-world study, significant improvements in urinary symptoms were seen following onabotulinumtoxinA treatment as early as week 1 and sustained to at least week 12. This was accompanied by a reduced reliance upon incontinence products and reduction in concomitant OAB medication use. OnabotulinumtoxinA was well tolerated with no new safety signals.
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http://dx.doi.org/10.1007/s00192-020-04423-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788019PMC
January 2021

The Stockholm Spinal Cord Uro Study: 2. Urinary tract infections in a regional prevalence group: frequency, symptoms and treatment strategies.

Scand J Urol 2020 Apr 9;54(2):155-161. Epub 2020 Mar 9.

Department NVS, Division of Clinical Geriatrics, Karolinska Institute, Stockholm, Sweden.

To examine symptomatic urinary tract infections (UTI) in a regional prevalence group of patients with traumatic spinal cord injury (SCI), to assess risk factors for recurring infections and to identify a high-risk sub-population for frequently recurring and severe febrile UTIs. Four hundred and twelve patients who attended a yearly check-up at the Spinalis SCI clinic were included. A regional programme for neurogenic bladder dysfunction was applied, including S-creatinine and S-cystatin-C, urine culture, residual urine, ultrasound of kidneys, urodynamic studies and a questionnaire regarding complications during the preceding year. Descriptive statistics and regression analysis were used to estimate risk factors. Nearly half of all patients reported ≥1 UTI during the preceding year with a mean number of 3.6. Persons who use normal voiding had the lowest frequency, while those with catheter-assisted voiding reported the highest numbers. A sub-group of patients had more frequent and severe UTIs. They were characterized by a cervical or thoracic neurological level lesion and a more severe injury and the presence of SCI-related complications such as spasticity, neuropathic pain and autonomic dysreflexia. The most common signs and symptoms of UTI were smelly and cloudy urine, feelings of malaise and increased spasticity. Risk profiles for recurring and severe UTIs were catheter-assisted voiding, cervical or thoracic levels and more complete neurological lesions and the co-existence of other SCI-related complications. There is a need for an increased understanding of the special symptoms of UTI in this patient group and a strategy to avoid unspecific antibiotic treatment.
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http://dx.doi.org/10.1080/21681805.2020.1734078DOI Listing
April 2020

The Stockholm Spinal Cord Uro Study: 1. Basic characteristics and problem inventory.

Scand J Urol 2019 Dec 21;53(6):403-410. Epub 2019 Oct 21.

Department NVS Division of Clinical Geriatrics, Karolinska Institutet, Solna, Sweden.

To assess urinary tract function and complications in a regional prevalence group of patients with traumatic spinal cord injury (SCI), and to estimate risk factors for recurring complications. A total of 412 patients who attended a yearly check-up at the Spinalis SCI clinic were included. A regional follow-up programme for neurogenic bladder dysfunction was applied, including S-creatinine and S-cystatin-C, urine culture, residual urine, ultrasound of kidneys, urodynamic studies, and a questionnaire regarding complications during the preceding year. Descriptive statistics and logistic regression were used to estimate risk factors. All patients completed blood tests and the questionnaire. A urine culture was completed by 96%, ultrasound by 88%, residual urine by 75%, urodynamics by 51%, and all parts of the study by 47%. One quarter of patients displayed pathological findings regarding kidney function. Urodynamics verified neurogenic overactive bladder in a majority, and a high proportion with intravesical filling pressures above 40 cm HO, a commonly used cut-off level for kidney safety. Subjectively, 47% of patients reported complications during the past year with urinary tract infection (UTI) as the most common one. Other complications were rare. With the aid of a regular follow-up programme, SCI patients can achieve a relatively stable situation regarding urinary tract function. UTI is the most common complication. Indicators of renal complications are frequent but not clearly related to the number of UTIs, nor to intravesical filling pressures. Main risk factors for complications are cervical levels and more complete neurological lesions.
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http://dx.doi.org/10.1080/21681805.2019.1673812DOI Listing
December 2019

Efficacy and impact of botulinum toxin A on quality of life in patients with neurogenic detrusor overactivity: a randomised, placebo-controlled, double-blind study.

Scand J Urol Nephrol 2007 ;41(4):335-40

Department of Urology, Karolinska University Hospital, S-171 76 Stockholm, Sweden.

Objective: To evaluate the effect of a single injection of 500 U of botulinum toxin A (BTX-A; Dysport) on use of oral rescue medication, bladder compliance, continence and quality of life in a randomized, placebo-controlled, double-blind study in patients with incontinence due to neurogenic detrusor overactivity. As this group of patients often have severe symptoms, oral tolterodine was allowed as rescue medication and the amount of tolterodine consumed was our primary endpoint.

Material And Methods: A total of 31 patients with urinary leakage due to spinal cord injury, myelomeningocele, trauma at birth, multiple sclerosis and myelitis of another cause were randomized to intravesical injections of either 500 U of BTX-A or placebo. Intake of tolterodine and episodes of urinary leakage were registered. Cystometry was performed after 6, 12 and 26 weeks and quality of life was assessed.

Results: Patients in the BTX-A group had a significantly lower intake of tolterodine throughout the study compared to those in the placebo group (p=0.003). Cystometric capacity was significantly higher at 6 (p<0.001) and 12 weeks (p=0.026) and maximum detrusor pressure and frequency of urinary leakage were significantly (p<0.01) lower during follow-up in the BTX-A group compared to the placebo group. In addition, many quality-of-life parameters were significantly improved in the BTX-A group compared to the placebo group.

Conclusions: Intravesical injection of 500 U of BTX-A in patients with neurogenic detrusor instability was shown to be an effective treatment which reduced use of oral medication, high detrusor pressure and frequency of urinary leakage during the overall study period of 26 weeks. Quality of life was also significantly improved.
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http://dx.doi.org/10.1080/00365590601068835DOI Listing
January 2008

Treatment of stress urinary incontinence using a copolymer system: impact on quality of life.

BJU Int 2004 Nov;94(7):1040-3

Department of Urology, University Hospital Maastricht, The Netherlands.

Objective: To investigate the effect on quality of life (QoL) of a novel system for treatment of stress urinary incontinence (SUI).

Patients And Methods: In an open, prospective, multicentre study, 42 women not previously treated by invasive therapy and with urodynamically verified SUI received 4 x 1.0 mL or 4 x 0.7 mL of non-animal stabilized hyaluronic acid/dextranomer copolymer injected transurethrally into the urethra via the Implacer device (Zuidex system, Q-Med AB, Uppsala, Sweden). QoL was assessed using the King's Health Questionnaire. The patients' perception of treatment benefit and the number of incontinence episodes/24 h were also investigated.

Results: There were significant improvements over baseline in seven of 10 domains of the King's Health Questionnaire at 3 months, and these improvements were sustained at 1 year. For the change from baseline to 1 year, eight of 10 domains showed a significant positive correlation with the number of incontinence episodes/24 h. In terms of treatment benefit, most of the women perceived an improvement at 1, 3, 6 and 12 months. Of the 18 women requiring re-treatment, most perceived an improvement at 3, 6 and 12 months.

Conclusion: Treatment with the Zuidex system produced significant improvements over a year in both subjective QoL and objective incontinence measures, with a significant positive correlation between them.
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http://dx.doi.org/10.1111/j.1464-410X.2004.05101.xDOI Listing
November 2004

Efficacy and safety of a novel system (NASHA/Dx copolymer using the Implacer device) for treatment of stress urinary incontinence.

Urology 2004 Aug;64(2):276-81

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

Objectives: To investigate the efficacy and safety of non-animal-stabilized hyaluronic acid/dextranomer (NASHA/Dx) copolymer for transurethral injection using a new guiding instrument (the Implacer) for stress urinary incontinence.

Methods: In an open, prospective, multicenter study, 42 invasive therapy-naive female patients with stress urinary incontinence were given 4 x 1.0 mL or 4 x 0.7 mL of NASHA/Dx copolymer using the Implacer. The efficacy parameters, measured at baseline and 1, 3, 6, and 12 months after treatment, included cough-induced leak point pressure, urine leakage by provocation test, number of incontinence episodes in 24 hours, and patient perception of bladder condition, rated on a 6-point scale.

Results: The collected cough-induced leak point pressure data were not judged to be valid and reliable. Statistically significant reductions in median urine leakage were observed (P <0.0001), from 36 g (range 0.0-300) after 20 "jumping jacks" or vigorous coughs at baseline to 5.5 g (range 0.0-98) at 3 months and sustained at 12 months (7.0 g, range 0.0-98). Of the 42 patients, 32 (76%) demonstrated a degree of improvement in urine leakage at 3 and 12 months. The median number of incontinence episodes in 24 hours decreased significantly from 1.9 (range 0.0-24) at baseline to 0.4 (range 0.0-24) at 12 months (P <0.0001). At both 3 and 12 months, 29 patients (69%) had improved by at least one category on the 6-point patient perception scale. Treatment was well tolerated, and no complications were reported with use of the Implacer.

Conclusions: The results of this study indicate that a novel system (NASHA/Dx copolymer insertion using the Implacer) is an effective and well-tolerated treatment for invasive therapy-naive patients with stress urinary incontinence, with improvement sustained for at least 12 months. These encouraging results warrant additional study.
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http://dx.doi.org/10.1016/j.urology.2004.03.017DOI Listing
August 2004

Treatment of stress urinary incontinence: recent developments in the role of urethral injection.

Urol Res 2003 Feb 30;30(6):356-62. Epub 2003 Jan 30.

Department of Urology, University Hospital Maastricht, The Netherlands.

Stress urinary incontinence is prevalent in adult women and has a considerable impact on quality of life. However, it often remains undiagnosed and therefore untreated. Non-invasive treatment is likely to be offered in mild cases and may entail physiotherapy, minimally invasive devices or pharmacotherapy. Surgical intervention is widely considered as the only effective option for more severe cases. These strategies are not suitable for all patients, and urethral injection represents an alternative, minimally invasive procedure. The choice of the bulking agent is the key to the success of this treatment: the most extensively studied are silicone, polytetrafluoroethylene and bovine collagen. However, doubts regarding the safety and efficacy of these materials has led to the development of carbon-coated zirconium beads, calcium hydroxylapatite and dextranomer/hyaluronic acid (Dx/HA) copolymer. Of these, the most clinical experience has been gained with Dx/HA copolymer. Until 2 years ago, urethral injection could only be administered endoscopically. The recent development of devices for 'blind' injection has increased the speed and convenience of urethral injection, removing the need for surgical facilities. Although few data are yet available, it is conceivable that urethral injection administered 'blind' may in future be considered as an option for all patients failing non-invasive treatment.
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http://dx.doi.org/10.1007/s00240-002-0290-1DOI Listing
February 2003