Contact information
Type
Scientific
Primary contact
Mr Yatin Thakur
ORCID ID
Contact details
Consultant Obs & Gynae
Basildon University Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom
+44 (0)1268 593521
Yatin.Thakur@btuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0035188760
Study information
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.
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
1. Pelvic organ prolapse quantification scale
2. Patient centered goals
3. Pelvic organ prolapse quality of life score
4. Surgical goals
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/08/2005
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
124 female patients (62 in each arm) with at least grade II uterovaginal prolapse with or without other vaginal wall defects.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
124
Participant exclusion criteria
Patients with previous surgery for prolapse can be included.
Recruitment start date
16/08/2005
Recruitment end date
01/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Obs & Gynae
Basildon
SS16 5NL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Basildon and Thurrock University Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary