Pelvic Organ Prolapse Clinical Trial
Official title:
VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not.
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.
The investigators 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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