Tension free vaginal tape (TVT) Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence – a Randomised Controlled Trial

Not Applicable

Recruiting

• Conditions: Renal and Urogenital - Other renal and urogenital disorders; Female stress urinary incontinence

• Registration Number: ACTRN12611001151921
• Lead Sponsor: Anna Rosamilia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

1. female patients with urodynamic stress incontinence Or Stress Urinary incontinence
2. Willing to participate and return for follow up
3. able to provide informed consent

Exclusion Criteria

1.Evidence of intrinsic sphincter deficiency
2.Previous failed suburethral tapes
3.Untreated Detrusor overactivity
4.Significant voiding dysfunction
5.Lower urinary tract anomaly (congenital)
6.Neurogenic bladder disorders
7.Previous radiation therapy to pelvis
8.Past history of any form of fistula involving the vagina
9.Allergy to polypropylene or local anaesthetic

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
objective cure rate for stress urinary incontinence<br><br>Definition of cure: negative cough stress test[6 months, 12months, 24 months, 36 months]

Secondary Outcome Measures

Name	Time	Method
subjective cure rate for stress urinary incontinence using ICIQ UI SF questionnare[6 months, 12months, 24 months, 36 months];subjective overactive bladder rate using ICIQ OAB[6 months, 12months, 24 months, 36 months];incontinence impact using IIQ7[6 months, 12months, 24 months, 36 months];global impression of improvement using PGI-I[6 months, 12months, 24 months, 36 months];sexual function using PISQ12[6 months, 12months, 24 months, 36 months]