Condition category
Urological and Genital Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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