A randomized controlled study to compare tension free vaginal tape (TVT) and Monarc trans-obturator tape (TOT) in the treatment of women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD).

Not Applicable

Completed

• Conditions: Intrinsic sphincter deficiency; Best surgical correction; Urodynamic stress incontinence; Renal and Urogenital - Other renal and urogenital disorders; Surgery - Surgical techniques

• Registration Number: ACTRN12608000093381
• Lead Sponsor: Mercy Hospital for Women

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-18
• Study Completion: 2019-02-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 182

Inclusion Criteria

urodynamics stress incontinence with intrinsic sphincter deficiency

Exclusion Criteria

pelvic infection, voiding difficulty (defined at cystometry as maximum flow less than 15 mL per second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 mL), inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
subjective cure of urinary incontinence assessed with visual analog score, quality of life questionaires (UDI 6, IIQ 7)[ 6 months, longterm follow up 3 years post surgery];need for repeat surgical treatment[ 6 months after primary procedure];objective cure of urinary incontinence on urodynamics[ 6 months]

Secondary Outcome Measures

Name	Time	Method
surgical postoperative complication[ first six weeks postoperative];longterm surgical complications[ 6 months, longterm follow up 3 years post surgery];surgical intra-operative complication[ immediately]