Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty in women with at least grade II uterovaginal prolapse.

ISRCTN ISRCTN95545591
DOI https://doi.org/10.1186/ISRCTN95545591
Secondary identifying numbers N0035188760
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
28/10/2016
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

Mr Yatin Thakur
Scientific

Consultant Obs & Gynae
Basildon University Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom

Phone +44 (0)1268 593521
Email Yatin.Thakur@btuh.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePosterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty in women with at least grade II uterovaginal prolapse.
Study objectivesTo compare 2 procedures - Posterior Intravaginal Slingplasty & Vaginal Hysterectomy (standard operation) for uterovaginal prolapse in terms of efficacy, intra & postoperative morbidity, postoperative pain/discomfort, hospital stay, patients satisfaction, quality of life & surgical goals.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Prolapse
InterventionEducational randomised controlled trial - 2 arms:
Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty
Intervention typeOther
Primary outcome measure1. Pelvic organ prolapse quantification scale
2. Patient centered goals
3. Pelvic organ prolapse quality of life score
4. Surgical goals
Secondary outcome measuresNot provided at time of registration
Overall study start date16/08/2005
Completion date01/04/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants124
Key inclusion criteria124 female patients (62 in each arm) with at least grade II uterovaginal prolapse with or without other vaginal wall defects.
Key exclusion criteriaPatients with previous surgery for prolapse can be included.
Date of first enrolment16/08/2005
Date of final enrolment01/04/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Consultant Obs & Gynae
Basildon
SS16 5NL
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Basildon and Thurrock University Hospitals NHS Trust

No information available

NHS R&D Support Funding

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

28/10/2016: No publications found, verifying study status with principal investigator