Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

NCT ID: NCT04635566

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-01

Brief Summary

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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

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Conditions

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Incontinence Urinary Incontinence Urinary Bladder Cancer

Keywords

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Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mebeverine

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Placebo

Placebo one time/day at the evening.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo one time/day at the evening.

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo one time/day at the evening.

Intervention Type DRUG

Other Intervention Names

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Coloverine® SR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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NE-OBS

Identifier Type: -

Identifier Source: org_study_id