Randomised trial of tension-free vaginal tape and transobturator tape as treatment for urinary stress incontinence in women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34377436

Enrollment

200

Registered

2005-11-11

Start date

2004-10-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Urodynamic stress incontinence Urological and Genital Diseases Other disorders of urinary system

Interventions

TVT versus TVT-O

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Urodynamic stress incontinence 2. Primary continence procedure

Exclusion criteria

Exclusion criteria: 1. Detrusor overactivity 2. Voiding Dysfunction 3. Prolapse = pelvic organ prolapse quantification system (POP-Q) stage 2

Design outcomes

Primary

Measure	Time frame
1. Objective cure rate (24 hour pad test) 2. Subjective cure rate (Leakage on 3 day voiding dairy)	—

Secondary

Measure	Time frame
1. Change in quality of life (Kings Health Questionnaire [KHQ]) 2. Change in symptom severity (Bristol Female Lower Urinary Tract Symptom Questionnaire [BFLUTS], International Consultation on Incontinence questionnaire [ICIQ]) 3. Pre and postoperative complications 4. Pain at 1 hour and 1 week (Visual Analogue Scale [VAS])	—

Countries

United Kingdom

Outcome results

None listed

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