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

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. Identifier: NCT01230450
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : January 24, 2013
Aberdeen Royal Infirmary
Information provided by (Responsible Party):
University of Aberdeen

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).

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

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.


  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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Study Start Date : November 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. • 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

Secondary Outcome Measures :
  1. • Patient-reported Success rates [ Time Frame: 1 year ]

    Patient-reported Success rates

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01230450

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United Kingdom
(Grampian) Aberdeen Royal Infermary
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
Aberdeen Royal Infirmary
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Principal Investigator: Mohamed Abdel-Fattah, MRCOG University of Aberdeen
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Responsible Party: University of Aberdeen Identifier: NCT01230450    
Other Study ID Numbers: SI-TOT
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by University of Aberdeen:
urodynamic urinary incontinence, sub-urethral tape
Additional relevant MeSH terms:
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Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms