Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress

NCT01230450 | Completed Phase 1 DMC

• 1 other identifier: SI-TOT
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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).

Conditions

Female Stress Incontinence

Keywords

urodynamic urinary incontinence, sub-urethral tape

Outcome Measures

Primary Outcomes (1)

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

  * 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

  1 year

Secondary Outcomes (1)

• • Patient-reported Success rates

  1 year

Study Arms (2)

Single-incision Mini-slings (SIMS- Ajust)

EXPERIMENTAL

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)

standared med urethral sling (SMUS)

OTHER

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

Other: stand standard mid-urethral sling (TVT-O)

Interventions

sub-urethral tape (TVT-O) PROCEDURE

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

Single-incision Mini-slings (SIMS- Ajust)

stand standard mid-urethral sling (TVT-O) OTHER

standared med urethral sling (SMUS)

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• Aberdeen Royal Infirmary: collaborator

Study Sites (1)

(Grampian) Aberdeen Royal Infermary

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37888839 DERIVED

Study Officials

• Mohamed Abdel-Fattah, MRCOG

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

GB (1)