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NCT04635566 Clinical Trial

Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

Urinary Incontinence Clinical Trial

Official title:
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute. A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04635566
Other study ID # NE-OBS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date March 1, 2020

Study information
Verified date November 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this randomised trial, we hypothesised that mebeverine could enhance nocturnal continenece of Orthotopic Bladder Substitute (OBS) patients by decreasing the frequency and reduce maximum amplitude of uninhibited contractions of OBS ileum, and consequently it would increase the OBS capacity

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - nocturnal enuresis Exclusion Criteria: - daytime incontinence - Orthotopic Bladder Substitute (OBS) reconstruction surgery =2 years - chronic kidney disease - local tumor recurrence - adjuvant chemotherapy and/or radiotherapy - chronic retention requiring use of clean intermittent catheterization or indwelling urethral catheterization - suspected or known narrow-angle glaucoma - sensitivity to mebeverine.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.
mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening. 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.
• Placebo
Placebo one time/day at the evening.

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary assess the 3-months nocturnal continence rate comparing Urinary function domain from the bladder cancer index (BCI) questionnaire 3 months
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