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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01230450
First Posted: October 29, 2010
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aberdeen Royal Infirmary
Information provided by (Responsible Party):
University of Aberdeen
October 27, 2010
October 29, 2010
January 24, 2013
November 2009
October 2010   (Final data collection date for primary outcome measure)
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia [ Time Frame: 1 year ]
  • 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
Feasibility of the single incision sub-urethral tape to be done under local anaesthesia [ Time Frame: 1 year ]

Feasibility of the single incision sub-urethral tape to be done under local anaesthesia?

  • Number of women approached and declining LA
  • Number of women in LA group converted to GA
Complete list of historical versions of study NCT01230450 on ClinicalTrials.gov Archive Site
• Patient-reported Success rates [ Time Frame: 1 year ]

Patient-reported Success rates

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

Patient-reported Success rates [ Time Frame: 1 year ]

Patient-reported Success rates

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

Not Provided
Not Provided
 
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".

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Female Stress Incontinence
  • Procedure: sub-urethral tape (TVT-O)
    Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
  • Other: stand standard mid-urethral sling (TVT-O)
  • 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
    Intervention: Procedure: sub-urethral tape (TVT-O)
  • standared med urethral sling (SMUS)
    standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al.
    Intervention: Other: stand standard mid-urethral sling (TVT-O)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
October 2011
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01230450
SI-TOT
Yes
Not Provided
Not Provided
University of Aberdeen
University of Aberdeen
Aberdeen Royal Infirmary
Principal Investigator: Mohamed Abdel-Fattah, MRCOG University of Aberdeen
University of Aberdeen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP