Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

Mansoura University

Status: Completed

Conditions: Urinary Bladder Cancer; Urinary Incontinence; Incontinence

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04635566

NE-OBS

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Mebeverine

Active Comparator group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

Placebo one time/day at the evening.

Treatment:

Drug: Placebo