A randomised trial of transvaginal tape (TVT) versus transvaginal obturator tape (TVTO): a pilot study

ISRCTN ISRCTN86612493
DOI https://doi.org/10.1186/ISRCTN86612493
Secondary identifying numbers 04/0091
Submission date
09/08/2010
Registration date
21/10/2010
Last edited
06/12/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Alison Sambrook
Scientific

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

Study information

Study designPilot single centre un-blinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled pilot study comparing transvaginal obturator tape (TVTO) to transvaginal tape (TVT) for the treatment of genuine stress incontinence in women
Study hypothesisTo 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(s)Grampian Research Ethics Committee, 28/05/2004, ref: 04/0091
ConditionStress urinary incontinence
InterventionThis 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/08/2004
Overall study end date31/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants40 women
Participant inclusion criteria1. Women aged over 18 years
2. Urodynamic stress incontinence
3. Failed conservative treatment
4. Being offered surgery
Participant exclusion criteria1. 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 date01/08/2004
Recruitment end date31/01/2006

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Obstetrics & Gynaecology
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

University of Aberdeen
University/education

University Medical School
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom

Email p.hannaford@abdn.ac.uk
Website http://www.abdn.ac.uk/
ROR logo "ROR" https://ror.org/016476m91

Funders

Funder type

University/education

University of Aberdeen
Private sector organisation / Universities (academic only)
Alternative name(s)
ABDN
Location
United Kingdom
NHS Grampian

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 06/12/2019 No No

Additional files

ISRCTN86612493_Basic Results_2006.pdf
uploaded 06/12/2019

Editorial Notes

06/12/2019: The basic results of this trial have been uploaded as an additional file.
23/09/2016: No publications found, verifying study status with principal investigator