Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

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

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Key information

Conditions

Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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.

Other names: Coloverine® SR

Placebo

Drug

Placebo one time/day at the evening.

Primary outcomes

assess the 3-months nocturnal continence rate

Time frame: 3 months

comparing Urinary function domain from the bladder cancer index (BCI) questionnaire

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 19, 2020
Registry last updated: Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting