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
1 other identifier
interventional
110
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJune 30, 2020
May 1, 2017
2 years
March 15, 2017
June 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Effect of mebeverine on patient quality of life by assessing patient quality of life measured by quality of life questionnaire
10 months
Effect of mebeverine on orthotopic w-ileal neobladders urodynamics by assessing simple urodynamic parameter
10 months
Study Arms (2)
Mebeverine
ACTIVE COMPARATORColoverin (Mebeverine hydrochloride 135 mg)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Men 18 years or older
- ONB within 1 year post-surgery.
You may not qualify if:
- Upper urinary tract deterioration
- Uncontrolled diabetes mellitus
- Evident local or pelvic recurrence
- Adjuvant chemotherapy
- Chronic retention
- Pouch stones
- Urethral stricture or urethro-ileal maldirection
- Sensitivity to Mebeverine
- Untreated chronic constipation
- Active symptomatic urinary infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hassan Abol-Enein, MD
Urology and Nephrology Center
- STUDY DIRECTOR
Ahmed Mosbah, MD
Urology and Nephrology Center
- PRINCIPAL INVESTIGATOR
Ahmed Elhussein, MBBCH
Urology and Nephrology Center
- PRINCIPAL INVESTIGATOR
Ahmed Elkarta, MBBCH
Urology and Nephrology Center
- PRINCIPAL INVESTIGATOR
Mohamed Soltan, MBBCH
Urology and Nephrology Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator
Study Record Dates
First Submitted
March 15, 2017
First Posted
May 10, 2017
Study Start
May 15, 2017
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
June 30, 2020
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)