Clinical trial NCT02995967: Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
Official title: Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptom Bother
timeFrame: 12 weeks
Secondary outcomes:
measure: Urge Urinary Incontinence Episodes
timeFrame: 12 weeks
measure: Total Number of Voids
timeFrame: 12 weeks
measure: Subjects Requiring Clean Intermittent Self-catheterization
timeFrame: 2 weeks
measure: Post Void Residual Volume
timeFrame: 2 weeks
measure: Rate of UTI
timeFrame: 2 weeks
measure: Quality of Life Measures
timeFrame: 12 weeks
measure: Patient Impression of Improvement
timeFrame: 12 weeks
measure: Patient Satisfaction
timeFrame: 12 weeks
measure: Quality of Life Measures
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Hospital
state: Alabama
Study officials:
References: