| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN95545591 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0035188760 |
| Public title | Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty in women with at least grade II uterovaginal prolapse. |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Urological and Genital Diseases: Prolapse |
| Study hypothesis | To 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 124 female patients (62 in each arm) with at least grade II uterovaginal prolapse with or without other vaginal wall defects. |
| Participants - exclusion criteria | Patients with previous surgery for prolapse can be included. |
| Patient information material |
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| Anticipated start date | 16/08/2005 |
| Anticipated end date | 01/04/2007 |
| Status of trial | Completed |
| Target number of participants | 124 |
| Interventions | Educational randomised controlled trial - 2 arms:
Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty |
| Primary outcome measure(s) | 1. Pelvic organ prolapse quantification scale
2. Patient centered goals
3. Pelvic organ prolapse quality of life score
4. Surgical goals |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Basildon and Thurrock University Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Yatin Thakur |
| Contact details | Consultant Obs & Gynae
Basildon University Hospital
Nethermayne
Basildon
United Kingdom
SS16 5NL |
| Contact telephone | +44 01268 593521 |
| Contact fax | +44 |
| Contact email | Yatin.Thakur@btuh.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN95545591 |
| Date last extracted from ISRCTN register | 17/04/2008 |
