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

ISRCTN	ISRCTN86612493
DOI	https://doi.org/10.1186/ISRCTN86612493
Protocol serial number	04/0091
Sponsor	University of Aberdeen
Funders	University of Aberdeen, NHS Grampian

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 of protocol

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

Primary study design	Interventional
Study design	Pilot single centre un-blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Grampian Research Ethics Committee, 28/05/2004, ref: 04/0091
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	31/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	40
Key inclusion criteria	1. Women aged over 18 years 2. Urodynamic stress incontinence 3. Failed conservative treatment 4. Being offered surgery
Key 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
Date of first enrolment	01/08/2004
Date of final enrolment	31/01/2006

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of Obstetrics & Gynaecology

Aberdeen
AB25 2ZN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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