Native tissue repair with surgical pelvic organ pessary - an RCT
Research type
Research Study
Full title
VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A TWO CENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
IRAS ID
200969
Contact name
Mark Slack
Contact email
Sponsor organisation
: Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Prolapse of the vagina is a common problem for women and varies from mildly bothersome to very problematic. About one in ten women in the developed world will require surgery for prolapse in their lifetime. The results of surgery are not perfect and some of women will develop prolapse again or not be satisfied with the result.
In this study a soft silicone support (SPOP) is inserted into the vagina straight after prolapse surgery. Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery. There will be 120 patients in the study; so 60 women will have the SPOP inserted.
We think that SPOP will support the vagina as it heals, improving the results of surgery. There are already some studies of the SPOP with other surgeries that show improved results. The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery. It is attached with two dissolving stiches to the vagina. After four weeks is will be removed in the out patient clinic without any discomfort. It is not usually painful or uncomfortable at any time.
The actual surgery the women have will not be any different had they not been in the study. All the women in the study will have the normal assessment prior to their operation, and will fill out some questionnaires about their symptoms too. All women involved in the study will come back the clinic to be seen after six months, one year and two years from the date of the surgery. This is regardless of whether they had the SPOP or not. When the women return they will be examined and complete the questionnaires again each visit.
The results of the study will be reported and published.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0289
Date of REC Opinion
30 Sep 2016
REC opinion
Further Information Favourable Opinion