Randomised controlled trial of transvaginal tension-free vaginal tape-obturator (TVT-O) versus Monarc in treatment of urodynamic stress incontinence

ISRCTN ISRCTN71562338
DOI https://doi.org/10.1186/ISRCTN71562338
Secondary identifying numbers 05/Q1104/176
Submission date
28/01/2006
Registration date
16/03/2006
Last edited
10/07/2017
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alison Peattie
Scientific

Countess of Chester Hospital
Liverpool Road
Chester
CH2 1UL
United Kingdom

Study information

Study designRandomised 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 to request a patient information sheet
Scientific titleRandomised controlled trial of transvaginal tension-free vaginal tape-obturator (TVT-O) versus Monarc in treatment of urodynamic stress incontinence
Study objectivesA comparison of two different ways of placing a suburethral tape (surgical procedure) to correct Urodynamic Stress Incontinence (USI). An assessment of the success rate and complications of the two procedures.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrodynamic Stress Incontinence (USI)
InterventionRandomised controlled trial, patient allocation by random numbers with blocking

Surgery - either of two ways of placing a transobturator tape to correct the incontinence, tension-free vaginal tape-obturator (TVT-O) versus Monarc
Intervention typeProcedure/Surgery
Primary outcome measureObjective and subjective cure of urodynamic stress incontinence
Secondary outcome measures1. Operating time
2. Blood loss
3. Complications
4. Pain
5. Catheter use post-operatively
6. Voiding
Overall study start date01/04/2006
Completion date31/03/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants320
Key inclusion criteria1. Females having a primary continence procedure without other surgery
2. Diagnosis of USI
3. Completed course of physiotherapy
4. Completed family
Key exclusion criteria1. Previous continence or prolapse surgery
2. Neurological disease
3. Pregnancy
4. Urinary tract or vaginal infection
5. Detrusor overactivity
6. Voiding problem
7. Anticoagulant use
Date of first enrolment01/04/2006
Date of final enrolment31/03/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Countess of Chester Hospital
Chester
CH2 1UL
United Kingdom

Sponsor information

Countess of Chester NHS Foundation Trust (UK)
Hospital/treatment centre

Liverpool Road
Chester
CH2 1UL
England
United Kingdom

ROR logo "ROR" https://ror.org/0149cpy58

Funders

Funder type

Industry

Any expenses incurred will be covered by Gynecare and American Medical Systems who produce the two tapes

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

Editorial Notes

10/07/2017: No publications found, verifying study status with principal investigator.