Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

Not Applicable

Completed

• Conditions: Urinary Bladder Cancer; Incontinence; Urinary Incontinence
• Interventions: Drug: mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.; Drug: Placebo

• Registration Number: NCT04635566
• Lead Sponsor: Mansoura University

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-14
• Last Update Submitted: 2020-11-14
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• nocturnal enuresis

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mebeverine	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.
Placebo	Placebo	Placebo one time/day at the evening.

Primary Outcome Measures

Name	Time	Method
assess the 3-months nocturnal continence rate	3 months	comparing Urinary function domain from the bladder cancer index (BCI) questionnaire

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt