Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/22/2018 |
| Start Date: | November 2015 |
| End Date: | June 26, 2017 |
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
The purpose of this study is to test whether using belladonna & opiate suppositories (B&Os)
can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder
for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial
cystitis.
can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder
for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial
cystitis.
Inclusion Criteria:
- Met clinical criteria under outside care or during the Principal Investigator's
routine standard of care for BoNT injection therapy
- No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
- Participants have elected to have the BoNT injection therapy prior to being offered
enrollment into the study for either overactive bladder (OAB), neurogenic detrusor
overactivity (NDO), or refractory interstitial cystitis (IC)
Exclusion Criteria:
- Currently pregnant
- Currently nursing a baby
- Anticipated geographic relocation within the first 3 months following treatment
- Allergy to morphine, belladonna, or opiates
- Patients will be excluded if participating in another research study
- Individuals unable to provide informed consent or to complete two-week follow-up
bladder testing (post-void residual) or data collection will also be excluded
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2
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