NCT00843908|Completed
Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling
A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.
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A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.
Sponsor study identifier
interventional
70
1 country
1
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)Study Completion
August 2009
Actual (reported)The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is proven, the advantages to women with USI will be potentially significant since the Miniarc may be carried out as an office based procedure, negating the need for an anaesthetic and hospital admission. The investigators null hypothesis is that there is no difference in subjective or objective outcome between the TVT and the Miniarc in the treatment of USI. Eligible women will be initially assessed with a full history and examination, King's Health Questionnaire and twin channel subtraction cystometry. They will be randomised (using a series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective assessment and repeat twin channel cystometry.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 12, 2009
Actual (reported)February 13, 2009
Actual (reported)March 2009
Actual (reported)August 2009
Actual (reported)The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics.
6 weeks and 6 months
Quality of life (as measured using the King's Health Questionnaire)
6 weeks and 6 months
Intra-operative complications, e.g. bladder injury
Time of surgery
Post-operative voiding dysfunction
0-6 weeks
Women in this arm will undergo the Tension Free Vaginal Tape procedure
Women in this group will undergo the Miniarc suburethral sling procedure
Tension Free Vaginal Tape inserted in the conventional manner in a theatre environment
The Miniarc suburethral sling will be inserted in the conventional manner in a theatre environment under general anaesthesia
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY, United Kingdom
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.
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)Transobturator Verus Single Incision Slings
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
August 2009
Actual (reported)Last Updated
August 27, 2009
Record last verified: 2009-08
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Source: ClinicalTrials.gov.
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