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Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

NCT02600715 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-09-20

Study results available
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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

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

Sponsors & Collaborators

  • Edgar LeClaire, MD

    lead OTHER

Principal Investigators

  • Edgar LeClaire, MD, FACOG · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-06-26
Completion
2017-06-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600715 on ClinicalTrials.gov