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

Stopped early · Not applicable

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT02995967

Run by

University of Alabama at Birmingham

People needed

3

Starts

2016-11-01

Expected to finish

2017-12-31

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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