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

• Status: Terminated
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

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