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

This study has been completed.
Sponsor:
Collaborator:
Aberdeen Royal Infirmary
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01230450
First received: October 27, 2010
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Female Stress Incontinence
 Procedure: sub-urethral tape (TVT-O)
Other: stand standard mid-urethral sling (TVT-O)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia?
    • Number of women approached and declining LA o Number of women in LA group converted to GA


Secondary Outcome Measures:
  • • Patient-reported Success rates [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Patient-reported Success rates

    o Assessed by PGI-I "Very Much Improved/ Much Improved."



Enrollment: 137
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Procedure: sub-urethral tape (TVT-O)
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.
 Other: stand standard mid-urethral sling (TVT-O)

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".

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230450

Locations
United Kingdom
(Grampian) Aberdeen Royal Infermary
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
Aberdeen Royal Infirmary
Investigators
Principal Investigator: Mohamed Abdel-Fattah, MRCOG University of Aberdeen
  More Information

No publications provided

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01230450     History of Changes
Other Study ID Numbers: SI-TOT
Study First Received: October 27, 2010
Last Updated: January 23, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
urodynamic urinary incontinence, sub-urethral tape

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013