NCT04635566

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 14, 2020

Last Update Submit

November 14, 2020

Conditions

IncontinenceUrinary IncontinenceUrinary Bladder Cancer

Keywords

Incontinence

Outcome Measures

Primary Outcomes (1)

  • assess the 3-months nocturnal continence rate

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

    3 months

Study Arms (2)

Mebeverine

ACTIVE COMPARATOR

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.

Placebo

PLACEBO COMPARATOR

Placebo one time/day at the evening.

Drug: Placebo

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.

Also known as: Coloverine® SR
Mebeverine
PlaceboDRUG

Placebo one time/day at the evening.

Placebo

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nocturnal enuresis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder Neoplasms

Interventions

mebeverine

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUrinary Bladder Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2020

First Posted

November 19, 2020

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

EG(1)