Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
| Status: | Terminated |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | November 2016 |
| End Date: | December 31, 2017 |
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.
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.
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
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