Clinical trial · Interventional
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute. A Randomised Controlled Trial
NCT04635566CI-TRIAL-00048364completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Incontinence | — | UNRESOLVED | — |
| Urinary Bladder Cancer | Malignant Bladder Neoplasm | ALIAS | 0.90 |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening. | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mebeverine
- description
- Mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.
- interventionNames
- Drug: mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo one time/day at the evening.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- assess the 3-months nocturnal continence rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.