Randomised controlled trial of transvaginal tension-free vaginal tape-obturator (TVT-O) versus Monarc in treatment of urodynamic stress incontinence

Completed

• Conditions: rodynamic Stress Incontinence (USI); Urological and Genital Diseases; Urodynamic Stress Incontinence (USI)

• Registration Number: ISRCTN71562338
• Lead Sponsor: Countess of Chester NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-16
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

1. Females having a primary continence procedure without other surgery
2. Diagnosis of USI
3. Completed course of physiotherapy
4. Completed family

Exclusion Criteria

1. Previous continence or prolapse surgery
2. Neurological disease
3. Pregnancy
4. Urinary tract or vaginal infection
5. Detrusor overactivity
6. Voiding problem
7. Anticoagulant use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective and subjective cure of urodynamic stress incontinence

Secondary Outcome Measures

Name	Time	Method
1. Operating time<br>2. Blood loss<br>3. Complications<br>4. Pain<br>5. Catheter use post-operatively<br>6. Voiding<br>