Bladder Cancer Clinical Trial
Official title:
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
NCT number | NCT03147599 |
Other study ID # | R/17.02.32 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 15, 2017 |
Est. completion date | May 1, 2019 |
Verified date | May 2017 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | May 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center | Mansoura | Aldakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of mebeverine on daytime and nocturnal incontinence by assessing continence status measured by standardized continence questionnaire | Outcome Measure by standardized continence questionnaire | 10 months | |
Secondary | Effect of mebeverine on patient quality of life by assessing patient quality of life measured by quality of life questionnaire | Outcome Measure by quality of life questionnaire | 10 months | |
Secondary | Effect of mebeverine on orthotopic w-ileal neobladders urodynamics by assessing simple urodynamic parameter | Outcome Measure by pressure change measurement in centimetre of water. | 10 months |
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