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Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

Primary Purpose

Incontinence, Urinary Incontinence, Urinary Bladder Cancer

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Incontinence focused on measuring Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mebeverine

Placebo

Arm Description

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

Placebo one time/day at the evening.

Outcomes

Primary Outcome Measures

assess the 3-months nocturnal continence rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04635566

First Posted

November 14, 2020

Last Updated

November 14, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04635566

Brief Title

Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Incontinence, Urinary Incontinence, Urinary Bladder Cancer

Keywords

Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mebeverine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo one time/day at the evening.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Coloverine® SR

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

Placebo one time/day at the evening.

Primary Outcome Measure Information:

Title

assess the 3-months nocturnal continence rate

Description

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

Time Frame

3 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male patients

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansoura

State/Province

Aldakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

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Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

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