Female Sling Procedure
Primary Purpose
Urinary Incontinence,Stress
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
trans-obturator procedure
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence,Stress
Eligibility Criteria
Inclusion Criteria:
- adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study
Exclusion Criteria:
- Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
the classical TOT procedure
2 paramedian vertical incisions
Arm Description
performing the trans-obturator procedure through the standard vertical incision
performing the trans-obturator procedure through a new technique of 2 paramedian vertical incisions
Outcomes
Primary Outcome Measures
tape migration
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
tape migration
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
tape migration
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
Secondary Outcome Measures
continence after surgery
to evaluate success rate in treatment of stress urinary incontinence using stress cough test and urodynamic study
de-novo urgency
appearance of urgency incontinence from patient symptomology evaluation whether present or not
vaginal erosion
postoperative complication of TOT where vagina erosion may occur, (yes/no)
urine retention
postoperative complication of TOT ( present or not)
Full Information
NCT ID
NCT04571346
First Posted
September 19, 2020
Last Updated
September 27, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04571346
Brief Title
Female Sling Procedure
Official Title
A Two Paramedian Vaginal Incisions Versus the Standard Longitudinal Incision of Trans-Obturator Tape Procedure for Management of Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In trans-obturator tape (TOT), tension and location of the tape in mid urethral zone are directly related to the postoperative clinical outcome. Recurrence of symptoms of stress urinary incontinence has been related to tape migration in previous studies. The study aimed to increase the success rate of TOT procedure through a new surgical technique using a 2 paramedian vaginal incisions.
Detailed Description
the investigator innovated a new technique that involves a 2 paramedian vaginal incisions that allow more tape stabilization with sparing the dissection along the whole urethra ensuring intact overlying tissues and to create a tunnel in between the 2 incisions to pass the tape, making it supported proximally and distally with normal undissected tissues.
the study aims to assess the success rate of TOT and tape migration using a new surgical technique versus the standard procedure using vertical incision.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Female patients complaining of stress urinary incontinence will be selected for our study, at the urology department, Ain-shams University hospitals. Those patients will be randomized into 2 equal groups with a 1:1 ratio using sealed envelopes that will be prepared by the department's ethical committee, group 1 represents the classical TOT procedure while group 2 represents the 2 paramedian vertical incisions technique. Patients will be blinded to the type of intervention. Informed consent will be obtained for all patients before the surgery, Careful evaluation will be done including history taking, examination with a stress test and urodynamic study. Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients will be blinded to the type of intervention as well as the data collector and the statistician
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the classical TOT procedure
Arm Type
Active Comparator
Arm Description
performing the trans-obturator procedure through the standard vertical incision
Arm Title
2 paramedian vertical incisions
Arm Type
Experimental
Arm Description
performing the trans-obturator procedure through a new technique of 2 paramedian vertical incisions
Intervention Type
Procedure
Intervention Name(s)
trans-obturator procedure
Intervention Description
TOT procedure will be done using silicon-coated polypropylene tape that will be inserted at the mid-urethral portion. In group 1, a classical vertical vaginal incision will be done proximal to the external urethral meatus with dissection along the axis of the urethra till the mid-urethral zone that is identified by palpating the urethral catheter balloon through the vaginal at the bladder neck, while in group 2, two paramedian incisions will be done 1cm long in the anterior vaginal wall 2 cm apart parallel to the urethra till identification of the mid-urethral portion, communication will be done between the two incisions 1 cm wide in this area creating a tunnel where the tape will be placed, this technique provides healthy tissues proximal and distal to the tape that allows more stabilization and less migration. The rest of the procedure is the same as the standard procedure of Trans-obturator outside-in tension-free technique.
Primary Outcome Measure Information:
Title
tape migration
Description
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
Time Frame
to be evaluated at 3rd month postoperative
Title
tape migration
Description
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
Time Frame
to be evaluated at 6th month postoperative
Title
tape migration
Description
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
Time Frame
to be evaluated at12th month postoperative
Secondary Outcome Measure Information:
Title
continence after surgery
Description
to evaluate success rate in treatment of stress urinary incontinence using stress cough test and urodynamic study
Time Frame
to be evaluated at 3,6 and 12 month postoperative
Title
de-novo urgency
Description
appearance of urgency incontinence from patient symptomology evaluation whether present or not
Time Frame
to be evaluated at 12 month postoperative
Title
vaginal erosion
Description
postoperative complication of TOT where vagina erosion may occur, (yes/no)
Time Frame
to be evaluated up to 1 year post operative
Title
urine retention
Description
postoperative complication of TOT ( present or not)
Time Frame
to be evaluated in the first 24 hours postoperative
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
we evaluation the procedure of trans-obturator tape in female stress incontinence
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study
Exclusion Criteria:
Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.
12. IPD Sharing Statement
Plan to Share IPD
No
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Female Sling Procedure
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