Condition category
Urological and Genital Diseases
Date applied
09/08/2010
Date assigned
21/10/2010
Last edited
23/09/2016
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

Dr Alison Sambrook

ORCID ID

Contact details

Department of Obstetrics & Gynaecology
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/0091

Study information

Scientific title

A randomised controlled pilot study comparing transvaginal obturator tape (TVTO) to transvaginal tape (TVT) for the treatment of genuine stress incontinence in women

Acronym

Study hypothesis

To compare the effectiveness and costs of transvaginal tape (TVT) with transvaginal obturator tape (TVTO) and to use the data on health related quality of life as measured over the trial follow-up. This pilot study aimed to recruit 20 women to each treatment arm in order to enable a power calculation to be performed to establish the number of participants required for a definitive randomised controlled trial between the experimental and control treatment.

Ethics approval

Grampian Research Ethics Committee, 28/05/2004, ref: 04/0091

Study design

Pilot single centre un-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stress urinary incontinence

Intervention

This is a pilot single centre un-blinded randomised controlled trial with a 12 month follow-up. Randomisation is independently prepared numbered opaque sealed envelopes stored independently from the trial office.

Patients will be randomised to one of the following:
1. Experimental treatment: transvaginal obturator tape (TVTO)
2. Control treatment: transvaginal tape (TVT)

Patients were consented on admission to hospital but had previously received verbal information and written information leaflet at the urodynamic clinic or via post and again on admission to the ward. Women were randomised to one of the two procedures once consent had been obtained. The two interventions were performed as described by the manufacturing company, Gynecare. The operating surgeons were experienced in both forms of surgery and the procedure was performed in an operating theatre under either spinal or general anaesthetic dependant on the patient choice. Women were discharged typically on the day of surgery but discharge was determined by the ability to void a normal amount of urine.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Changes in International Consultation on Incontinence Questionnaire (ICIQ), assessed at baseline
2. Differences in quality adjusted life years (QALYs) estimated from responses to the EQ-5D, measured at baseline and 12 months

Secondary outcome measures

1. Subjective cure rate
2. Changes in the King's Health questionnaire (KHQ) scores
3. Difference in EQ-5D scores at three and twelve months follow-up
4. Operative data
5. Self-reported acceptability
6. Usage recommendation to a friend

All measured at baseline, two weeks (except for the EQ-5D), three months and twelve months.

Overall trial start date

01/08/2004

Overall trial end date

31/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged over 18 years
2. Urodynamic stress incontinence
3. Failed conservative treatment
4. Being offered surgery

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40 women

Participant exclusion criteria

1. Not prepared to accept surgery
2. Requiring additional prolapse surgery
3. Undergone previous surgery for stress urinary incontinence
4. Not completed their families, i.e., will still want children
5. Unable or unwilling to give informed consent
6. Unwilling to participate in follow-up

Recruitment start date

01/08/2004

Recruitment end date

31/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Obstetrics & Gynaecology
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

University of Aberdeen

Sponsor details

University Medical School
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
-
p.hannaford@abdn.ac.uk

Sponsor type

University/education

Website

http://www.abdn.ac.uk/

Funders

Funder type

University/education

Funder name

University of Aberdeen

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

NHS Grampian

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

Publication citations

Additional files

Editorial Notes

23/09/2016: No publications found, verifying study status with principal investigator