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Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04635566
Enrollment
120
Registered
2020-11-19
Start date
2019-03-01
Completion date
2020-03-01
Last updated
2020-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence, Urinary Bladder Cancer, Urinary Incontinence

Keywords

Incontinence

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

Interventions

DRUGmebeverine 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.

DRUGPlacebo

Placebo one time/day at the evening.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
assess the 3-months nocturnal continence rate3 monthscomparing Urinary function domain from the bladder cancer index (BCI) questionnaire

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026