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
Protocol serial number	N0035188760
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Basildon and Thurrock University Hospitals NHS Trust, NHS R&D Support Funding

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific 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.
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Prolapse
Intervention	Educational randomised controlled trial - 2 arms: Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty
Intervention type	Other
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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	124
Key inclusion criteria	124 female patients (62 in each arm) with at least grade II uterovaginal prolapse with or without other vaginal wall defects.
Key exclusion criteria	Patients with previous surgery for prolapse can be included.
Date of first enrolment	16/08/2005
Date of final enrolment	01/04/2007

Consultant Obs & Gynae

Basildon
SS16 5NL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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