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

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.

Study Overview

• Status: Terminated
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Botulinum toxin-A; Procedure: Hydrodistention

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Birmingham Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum toxin A alone group; Just the intradetrusor injection of 100 units of botulinum toxin A alone	Drug: Botulinum toxin-A; Intradetrusor injection of 100 units of botulinum toxin a
Experimental: Hydrodistention group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: F160629005