Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

Mansoura University120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Incontinence Urinary Incontinence Urinary Bladder Cancer

Interventions

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.

PlaceboDRUG

Placebo one time/day at the evening.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Outcomes

Primary Outcomes

assess the 3-months nocturnal continence rate

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

Time frame: 3 months

Data from ClinicalTrials.gov

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