NCT02600715

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Edgar LeClaire, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Overactive Bladder
• Urinary Urge Incontinence
• Urinary Bladder, Neurogenic
• Painful Bladder Syndrome

Interventions

Type	Name	Description
DRUG	Onabotulinumtoxin A (BoNT)
DRUG	belladonna	Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.
DRUG	Morphine	Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.
DRUG	Placebo	matching placebo to B\&O suppository
DRUG	Active B&O suppository of belladonna	belladonna 16.2mg and morphine 7.5mg

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-26
• Completion: 2017-06-26
• First posted: 2015-11-09
• Last updated: 2018-09-20
• Results posted: 2018-09-20

Locations

2 sites across 1 country: United States