Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder

Study Overview
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Brief Summary
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The specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin A has additional benefit in patients with refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection of botulinum toxin A alone. Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone (botulinum toxin A alone group). The primary aim will be subjective improvement measured as change from baseline at 12 weeks using the OAB-q bother subscale.

Official Title
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Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Procedure: Hydrodistention
* Drug: Botulinum toxin-A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with refractory overactive bladder symptoms, failing a credible behavioral therapy intervention and medical therapy or not tolerating medical therapy. Patients who are on medical therapy will stop the medical therapy for at least 2 weeks prior to botulinum toxin A treatment in the study Female ≥ 18 years old Desires further treatment for OAB symptoms. Express understanding and ability to perform clean intermittent self-catheterization (CISC) if required. Ability to consent Ability to complete all study related items and interviews Exclusion Criteria: Post void residual urine volume > 150 mL as assessed by catheter or ultrasound History of intradetrusor botulinum toxin A injection History of or current cancer of the genitourinary or gynecology tract Neurogenic bladder Interstitial cystitis Current urinary tract infection (can be treated and re-considered for study) Current active sacral neuromodulation device Non-English speaking History of chronic pelvic pain Hematuria not previously evaluated

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin A alone group<br>Just the intradetrusor injection of 100 units of botulinum toxin A alone | Drug: Botulinum toxin-A<br>* Intradetrusor injection of 100 units of botulinum toxin a<br>|
| Experimental: Hydrodistention group<br>Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A | Procedure: Hydrodistention<br>* The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Bother | The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urge Urinary Incontinence Episodes | Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline. | 12 weeks | 
| Total Number of Voids | Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline. | 12 weeks | 
| Subjects Requiring Clean Intermittent Self-catheterization | Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of > 300 mL or > 150 mL in the presence of bothersome retention symptoms. | 2 weeks | 
| Post Void Residual Volume | Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan. | 2 weeks | 
| Rate of UTI | Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI. | 2 weeks | 
| Quality of Life Measures | Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. | 12 weeks | 
| Patient Impression of Improvement | Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I). | 12 weeks | 
| Patient Satisfaction | Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ). | 12 weeks | 
| Quality of Life Measures | Subjective outcome at 24 weeks using the OAB-q | 24 weeks |