Female Sling Procedure

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Urinary Incontinence,Stress

Treatments: Procedure: trans-obturator procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04571346

FMASU R51/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

the classical TOT procedure

Active Comparator group

Description:

performing the trans-obturator procedure through the standard vertical incision

Treatment:

Procedure: trans-obturator procedure

2 paramedian vertical incisions

Experimental group

Description:

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

Treatment:

Procedure: trans-obturator procedure