Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stress Urinary Incontinence

Treatments: Procedure: tension free vaginal tape; Procedure: single incision minisling

Study type: Interventional

Funder types: Other

Identifiers

NCT02263534

SIMS001

Details and patient eligibility

About

Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.

Enrollment: 48 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse

Exclusion criteria

• Patients with overactive bladder on urodynamic study.
• Patients with voiding dysfunction.
• Patients with intrinsic sphincteric deficiency.
• Patients with previous anti-incontinence surgery.
• Patients on anti-coagulant therapy.
• Immune-compromised patients (DM, patients on corticosteroids treatment).
• Refusal of surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups

minisling

Experimental group

Description:

patients in this arm will undergo single incision minisling

Treatment:

Procedure: single incision minisling

tension free vaginal tape

Sham Comparator group

Description:

patients in this arm will undergo tension free vaginal tape

Treatment:

Procedure: tension free vaginal tape