Female Sling Procedure

NCT04571346 | Completed Phase 2 DMC

• 1 other identifier: FMASU R51/2019
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence,Stress

Outcome Measures

Primary Outcomes (3)

• tape migration

  to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound

  to be evaluated at 3rd month postoperative

• tape migration

  to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound

  to be evaluated at 6th month postoperative

• tape migration

  to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound

  to be evaluated at12th month postoperative

Secondary Outcomes (4)

• continence after surgery

  to be evaluated at 3,6 and 12 month postoperative

• de-novo urgency

  to be evaluated at 12 month postoperative

• vaginal erosion

  to be evaluated up to 1 year post operative

• urine retention

  to be evaluated in the first 24 hours postoperative

Study Arms (2)

the classical TOT procedure

ACTIVE COMPARATOR

performing the trans-obturator procedure through the standard vertical incision

Procedure: trans-obturator procedure

2 paramedian vertical incisions

EXPERIMENTAL

performing the trans-obturator procedure through a new technique of 2 paramedian vertical incisions

Procedure: trans-obturator procedure

Interventions

trans-obturator procedure PROCEDURE

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.

2 paramedian vertical incisions; the classical TOT procedure

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: we evaluation the procedure of trans-obturator tape in female stress incontinence
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study

You may not qualify if:

• Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to the type of intervention as well as the data collector and the statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of Urology

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: October 1, 2020
• Study Start: January 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share