Condition category
Urological and Genital Diseases
Date applied
16/09/2005
Date assigned
11/11/2005
Last edited
13/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Christopher Mayne

ORCID ID

Contact details

Directorate of Women's
Perinatal & Sexual Health
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
christopher.mayne@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9452

Study information

Scientific title

Acronym

Study hypothesis

To compare the cure rate and complication rate of the tension-free vaginal tape (TVT) and tension free vaginal tape obturator (TVT-O) procedure (TVT & TVT-O, Gynecare, Somerville, New Jersey)

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urodynamic stress incontinence

Intervention

TVT versus TVT-O

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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])

Overall trial start date

01/10/2004

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Urodynamic stress incontinence
2. Primary continence procedure

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

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

Recruitment start date

01/10/2004

Recruitment end date

01/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Directorate of Women's, Perinatal & Sexual Health
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Research & Development Directorate
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
nicola.turner@uhl-tr.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

University Hospitals of Leicester NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21334654

Publication citations

  1. Results

    Teo R, Moran P, Mayne C, Tincello D, Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women., J. Urol., 2011, 185, 4, 1350-1355, doi: 10.1016/j.juro.2010.11.064.

Additional files

Editorial Notes