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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71562338

Enrollment

320

Registered

2006-03-16

Start date

2006-04-01

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urodynamic Stress Incontinence (USI) Urological and Genital Diseases Urodynamic Stress Incontinence (USI)

Interventions

Randomised controlled trial, patient allocation by random numbers with blocking Surgery - either of two ways of placing a transobturator tape to correct the incontinence, tension-free vaginal tape-ob

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Objective and subjective cure of urodynamic stress incontinence	—

Secondary

Measure	Time frame
1. Operating time 2. Blood loss 3. Complications 4. Pain 5. Catheter use post-operatively 6. Voiding	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026