Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders
Primary Purpose
Oncology, Incontinence, Incontinence, Daytime Urinary
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Coloverin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Oncology focused on measuring Mebeverine, Incontinence, Orthotopic Neobladder
Eligibility Criteria
Inclusion Criteria:
- Men 18 years or older
- ONB within 1 year post-surgery.
Exclusion Criteria:
- 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
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mebeverine
Placebo
Arm Description
Coloverin (Mebeverine hydrochloride 135 mg)
Placebo
Outcomes
Primary Outcome Measures
Effect of mebeverine on daytime and nocturnal incontinence by assessing continence status measured by standardized continence questionnaire
Outcome Measure by standardized continence questionnaire
Secondary Outcome Measures
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
Effect of mebeverine on orthotopic w-ileal neobladders urodynamics by assessing simple urodynamic parameter
Outcome Measure by pressure change measurement in centimetre of water.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03147599
Brief Title
Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
In appropriately selected patients an orthotopic neobladder (ONB) permits the elimination of an external stoma and preservation of body image without compromising cancer control after radical cystectomy. Voiding dysfunction (VD) following ONB can be divided into failure to empty bladder or failure to store urine. Failure to empty bladder by angulation of urethra is the most common cause. Failure to store urine can occur during daytime, night-time or both. VD that persists beyond 6 to 12 months warrants urodynamics evaluation to determine the cause and suggest plane of therapy. Voiding dysfunction has a detrimental impact on quality of life.
Among the various bowel segments studied, the ileum is ideal for ONB creation. A spherical reservoir, reconfigured from a de-tubularized ileal segment, offers the most desirable attributes like, adequate capacity, low intraluminal pressure, and good compliance. The patient of ONB reported 4-25% rate of clean intermittent self-catheterisation (CISC) for incomplete emptying. Daytime incontinence was present in 13% of patients. The rate of nocturnal incontinence is usually higher in the range of 15-40% in recent metanalysis. The success of ONB rely on detubularization of intestinal segment, sufficient capacity and proper configuration and position in the pelvis. Adequate capacity is achieved by using sufficient length, folding, and creation an ellipsoid or spherical configuration. The ONB should hold approximately 500 cc of urine at low pressure (at < 15 cm H2O), empty completely (< 100 cc urine), four to five times daily and allow the patient to sleep without awakening, while maintain normal body image
loss of the vesico-urethral reflex 'guarding reflex' in which increased urethral sphincter tone parallel to bladder distension, decreased patient vigilance during sleep resulting in reduced muscle tone and urethral closing pressure, decreased sensitivity of the membranous urethra after radical cystectomy, involuntary high-amplitude contractions of the reservoir secondary to bowel peristalsis and shifting of free water from the reservoir wall into the hyperosmolar urine are the main factor causing global and nocturnal polyuria in patient with ONB. Final, there is also evidence suggesting an increase in bowel activity during sleep. Maximum urethral closing pressure (MUCP) is the primary component responsible for daytime continence in patients with an ONB. However, Koraitim et al. suggest that nocturnal incontinence depends on three reservoir parameters: maximal contraction amplitude, baseline reservoir pressure at mid capacity, and MUCP.
Mebeverine is a derivative of reserpine, which has relatively specific effects on smooth muscle cells without atropine-like side effects in humans. It directly blocks voltage-operated sodium channels and inhibits intracellular calcium accumulation. It is three times more potent than papaverine in inhibiting the peristaltic reflex of the ileum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Incontinence, Incontinence, Daytime Urinary, Incontinence, Nighttime Urinary, Bladder Cancer, Orthotopic Neobladder
Keywords
Mebeverine, Incontinence, Orthotopic Neobladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mebeverine
Arm Type
Active Comparator
Arm Description
Coloverin (Mebeverine hydrochloride 135 mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Coloverin
Other Intervention Name(s)
Mebeverine hydrochloride
Intervention Description
Mebeverine hydrochloride 135 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Effect of mebeverine on daytime and nocturnal incontinence by assessing continence status measured by standardized continence questionnaire
Description
Outcome Measure by standardized continence questionnaire
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Effect of mebeverine on patient quality of life by assessing patient quality of life measured by quality of life questionnaire
Description
Outcome Measure by quality of life questionnaire
Time Frame
10 months
Title
Effect of mebeverine on orthotopic w-ileal neobladders urodynamics by assessing simple urodynamic parameter
Description
Outcome Measure by pressure change measurement in centimetre of water.
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men 18 years or older
ONB within 1 year post-surgery.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Abol-Enein, MD
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Mosbah, MD
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Elhussein, MBBCH
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Elkarta, MBBCH
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Soltan, MBBCH
Organizational Affiliation
Urology and Nephrology Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
Learn more about this trial
Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders
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