A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding

Study Overview
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Brief Summary
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Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology (Abrams et al 2002) Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit. The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time.

Detailed Description
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Urinary incontinences is a highly prevalent and distressing condition which has a significant impact on health related quality of life in millions of women worldwide. Of all women with incontinence, 90% will have overactive bladder symptoms (OAB), and 50% will have detrusor overactivity (DO) on cystometry. The overactive bladder syndrome is defined by the International Continence society as Urinary urgency, with or without urge incontinence, usually with frequency and nocturia if there is a no infection or proven pathology (Abrams et al 2002) Initial management of OAB and DO consists of conservative measures such as altering fluid intake, bladder retraining and drug therapy. The next step consists of interventions such as cystoscopy and urethral dilatation, on the basis that it will allow intrinsic bladder problems such as interstitial cystitis to excluded, excluded, and may confer a symptomatic benefit. Cystoscopy and urethral dilatation have long been advocated as empirical treatments for women with lower urinary tract symptoms (LUTS). A review of the literature reveals a marked lack of evidence regarding the survey of practice amongst UK urologists found that 61% had performed urethral dilatation 7 or more times during the year in which the survey was conducted, although 55% believed that less than half of the patients experience long term improvement (Masarani and Willis, 2006) The original study showed no benefit of urethral dilatation versus no dilatation at 6 months follow up (Duckett 2007). The investigators do not know the natural history of patients with voiding dysfunction. Therefore reviewing their symptoms will give a better idea of what happens to these patients symptoms over time. The aim of the study is to identify any long term benefit from urethral dilatation over cystoscopy alone.

Official Title
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A Follow-net Investigation of a Randomised Study of Cystoscopy and Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding

Conditions
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Overactive Bladder, Voiding Dysfunction, Urinary Incontinence

Intervention / Treatment
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* Procedure: Cystoscopy only
* Procedure: Cystoscopy and Urethral dilatation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Significant Overactive Bladder Symptoms Based on scoring 1 or 2 on the Urgency Perception Scale On the symptoms domain of the KHQ More than 8 voids per day on frequency volume chart +/- 2 or more episodes of nocturia Pressure flow studies demonstrate a maximum flow rate of less than 15ml on a minimum voided volume of 200ml with a high or normal detrusor pressure at maximum flow or post-void residual of 200ml or over Patients must be able to give informed consent for the study. Exclusion Criteria: Presence of concurrent urodynamic stress incontinence. Patients with bladder pathology or haematuria of unknown origin. Patients with neurological disorders (as these may affect voiding). Symptomatic pelvic organ prolapse requiring intervention Patients with bladder pathology (including urinary tract infection) or haematuria of unknown origin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cystoscopy Alone<br>Patients who received cystoscopy only for treatment of OAB and voiding dysfunction. | Procedure: Cystoscopy only<br>* Cystoscopy performed for investigation and treatment of OAB and voiding dysfunction<br>|
| Cystoscopy & Urethral Dilatation<br>Patients who received urethral dilatation and cystoscopy for treatment of OAB and voiding dysfunction. | Procedure: Cystoscopy and Urethral dilatation<br>* Cystoscopy and urethral dilatation performed for investigation and treatment of OAB and voiding dysfunction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICIQ-Fluts questionnaire | To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| King's Health Questionnaire | To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study. | 3 years | 
| Urgency Perception Scale Questionnaire | To identify if there is any long term benefit from urethral dilatation over cystoscopy alone. Their baseline symptoms will be assessed and compared to those identified at baseline in the previous study. | 3 years | 
| Uroflowmetry | Flow rates will be repeated in all patients allowing for an objective comparison post-operatively and 3 years later. | 3 years |