Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT

Launched by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Jun 16, 2016

Keywords

ClinConnect 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 hav...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with symptomatic pelvic organ prolapse requiring an anterior vaginal repair at the study centre.
• • Currently on the hospital waiting list for vaginal native tissue repair
• • Willingness to participate
• • Medically fit for surgery
• • 18 years or over
• • Reasonable level of English to complete questionnaires
• • Patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
• Exclusion Criteria:
• • Asymptomatic pelvic organ prolapse
• • Refusal to participate
• • Medically unfit for surgery
• • Under 18
• • Unable to complete questionnaires due to poor level of english
• • Patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach