Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress

NCT ID: NCT01230450

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-10-31

Brief Summary

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).

Detailed Description

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".

Conditions

Female Stress Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single-incision Mini-slings (SIMS- Ajust)

AjustTM has polypropylene fixing anchors (one is fixed and the other adjustable) which are anchored onto the obturator membrane. The pulley like system enables adjustment of the tension once the arms have been anchored. Once in place, the anchors rest at right angles to insertion which is claimed to reduce the chances of anchor dislodgment

Group Type: EXPERIMENTAL

sub-urethral tape (TVT-O)

Intervention Type: PROCEDURE

Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape

standared med urethral sling (SMUS)

standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al.

Group Type: OTHER

stand standard mid-urethral sling (TVT-O)

Intervention Type: OTHER

Interventions

sub-urethral tape (TVT-O)

Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape

Intervention Type: PROCEDURE

stand standard mid-urethral sling (TVT-O)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aberdeen Royal Infirmary

OTHER

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Abdel-Fattah, MRCOG

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

(Grampian) Aberdeen Royal Infermary

Aberdeen, Aberdeenshire, United Kingdom

Countries

United Kingdom

References

Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

Reference Type: DERIVED

PMID: 37888839 (View on PubMed)

Other Identifiers

SI-TOT

Identifier Type: -

Identifier Source: org_study_id