Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress

Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)

Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).

Single incision tension-free sub-urethral vaginal tapes procedures8 have been recently described in an attempt to avoid the blind passage of the trochars through the groin & the adductor muscles and consequently reducing the incidence & severity of postoperative leg pain. The obvious advantages would be shorter hospital stay, early recovery, early resumption of day to day activities & earlier return to work. A number of small prospective audits and case-series have been presented in international conferences reporting on the safety & outcomes for these procedures. However all these studies were for preliminary reports for proof of concept and therefore the studies populations were 15-70 women with short term follow-up of 2-3 month9-11.These studies have shown low perioperative complication rates: bladder injury 0-1%, vaginal erosion 1-3% & one study showing 1.3% pain at 6 weeks follow-up. The patient reported success rates were 77-93% at 2-3 month follow-up9-12.

Objectives:

1. Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
2. The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
3. To compare the surgical approach in this relatively new procedure against the standard procedures as regard: Peri-operative complication rates, Postoperative pain, Time to discharge from the hospital,
4. To compare the outcomes as regard: Patient-reported cure rates, Patient satisfaction, Impact on Quality of life (QoL) and sexual function at 3 month & 1 -year follow-up. The objective cure rates will be assessed at 3 month follow-up.

Design:

A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network".

Inclusion Criteria:

• USI
• Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).
• Primary Incontinence Surgery.
• BMI < 35
• Ability to understand the information leaflet and sign an informed consent form in English.
• All would have had failed or declined PFMT.

Exclusion Criteria:

• Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.
• Detrusor Overactivity on Urodynamics.
• Inability to understand English.
• Un-willing for randomisation.
• Concomitant surgery.
• Patient requiring postoperative hospital-stay for medical or social reasons