Clinical trial · Interventional
Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders
Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders - Assessment Of Efficacy And Quality Of Life Effect Within 1 Year Post-Surgery: A Randomized Controlled Study
NCT03147599CI-TRIAL-00045721completedPhase 4ClinicalTrials.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)
A randomized controlled trial to assess clinically the efficacy of the selective ileum spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal neobladders and quality of life effect within 1 year post-surgery.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Incontinence | — | UNRESOLVED | — |
| Incontinence, Daytime Urinary | — | UNRESOLVED | — |
| Incontinence, Nighttime Urinary | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Orthotopic Neobladder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coloverin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mebeverine
- description
- Coloverin (Mebeverine hydrochloride 135 mg)
- interventionNames
- Drug: Coloverin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Effect of mebeverine on daytime and nocturnal incontinence by assessing continence status measured by standardized continence questionnaire
- timeFrame
- 10 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men 18 years or older 2. ONB within 1 year post-surgery. Exclusion Criteria: 1. Upper urinary tract deterioration 2. Uncontrolled diabetes mellitus 3. Evident local or pelvic recurrence 4. Adjuvant chemotherapy 5. Chronic retention 6. Pouch stones 7. Urethral stricture or urethro-ileal maldirection 8. Sensitivity to Mebeverine 9. Untreated chronic constipation 10. Active symptomatic urinary infection
References
Publications (0)
Data not yet available
No reference posted for this study.