Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
Completed · Phase 4 · Has a placebo group
Conditions studied: Overactive Bladder, Urinary Urge Incontinence, Urinary Bladder, Neurogenic, Painful Bladder Syndrome
In brief
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.
Key facts
- Study ID
- NCT02600715
- Run by
- Edgar LeClaire, MD
- People needed
- 26
- Starts
- 2015-11-01
- Expected to finish
- 2017-06-26
- Last updated by the study team
- 2018-09-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Wichita Women's Pelvic Surgery Center at Associates in Women's Health — Wichita, Kansas, United States
- University of Kansas School of Medicine - Wichita — Wichita, Kansas, United States
Full record on ClinicalTrials.gov
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