Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT (NTRSPOP)

NHS Foundation Trust

Status

Unknown

Conditions

Pelvic Organ Prolapse

Treatments

Other: Surgical Pelvic Organ Pessary

Study type

Interventional

Funder types

Other

Identifiers

NCT02808377

A094029

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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