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

Not Applicable

Terminated

• Conditions: Overactive Bladder
• Interventions: Drug: Botulinum toxin-A; Procedure: Hydrodistention

• Registration Number: NCT02995967
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Results First Submitted: 2018-06-23
• Results First Submitted QC: 2018-11-19
• Results First Posted: 2018-12-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-15
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin A alone group	Botulinum toxin-A	Just the intradetrusor injection of 100 units of botulinum toxin A alone
Hydrodistention group	Hydrodistention	Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A

Primary Outcome Measures

Name	Time	Method
Symptom Bother	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Subjects Requiring Clean Intermittent Self-catheterization	2 weeks	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.
Post Void Residual Volume	2 weeks	Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
Rate of UTI	2 weeks	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.
Urge Urinary Incontinence Episodes	12 weeks	Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.
Total Number of Voids	12 weeks	Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.
Quality of Life Measures	24 weeks	Subjective outcome at 24 weeks using the OAB-q
Patient Impression of Improvement	12 weeks	Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).
Patient Satisfaction	12 weeks	Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).

Trial Locations

Locations (1)

University of Alabama Birmingham Hospital; 🇺🇸 Birmingham, Alabama, United States