Back to resultsTOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence
Primary Purpose
Treatment
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TOT
TVT
Burch Colposuspension
Sponsored by
About this trial
This is an interventional treatment trial for Treatment focused on measuring Mixed urinary incontinence, Transobturator tape (TOT), Tension-Free Vaginal Tape (TVT), Burch colposuspension, Urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- Women with mixed urinary incontinence.
Exclusion Criteria:
- Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
- Women who improved on medical treatment with persistence of stress element only were also excluded.
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
TOT
TVT
Burch colposuspension
Arm Description
TOT
TVT
Burch colposuspension
Outcomes
Primary Outcome Measures
objective cure rate
subjective cure rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02775526
Brief Title
TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence
Official Title
Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
5. Study Description
Brief Summary
This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment
Keywords
Mixed urinary incontinence, Transobturator tape (TOT), Tension-Free Vaginal Tape (TVT), Burch colposuspension, Urinary incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOT
Arm Type
Active Comparator
Arm Description
TOT
Arm Title
TVT
Arm Type
Active Comparator
Arm Description
TVT
Arm Title
Burch colposuspension
Arm Type
Active Comparator
Arm Description
Burch colposuspension
Intervention Type
Procedure
Intervention Name(s)
TOT
Other Intervention Name(s)
Trans-Obturator Tape
Intervention Description
70 patients
Intervention Type
Procedure
Intervention Name(s)
TVT
Other Intervention Name(s)
Tension-Free Vaginal Tape
Intervention Description
70 patients
Intervention Type
Procedure
Intervention Name(s)
Burch Colposuspension
Intervention Description
70 patients
Primary Outcome Measure Information:
Title
objective cure rate
Time Frame
2 years
Title
subjective cure rate
Time Frame
2 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with mixed urinary incontinence.
Exclusion Criteria:
Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
Women who improved on medical treatment with persistence of stress element only were also excluded.
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence
We'll reach out to this number within 24 hrs