Clinical trial NCT02808377: Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT
Official title: VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Success in anterior compartment.
timeFrame: 6 months post operative
measure: Success in Anterior Compartment
timeFrame: 12 months post operative
measure: Success in Anterior Compartment
timeFrame: 24months post operative
Secondary outcomes:
measure: Change in POP-Q quantitative measurements from baseline
timeFrame: 6 months
measure: Change in POP-Q quantitative measurements from baseline
timeFrame: 12 months
measure: Change in POP-Q quantitative measurements from baseline
timeFrame: 24 months
measure: Division of vaginal band
timeFrame: 6months
measure: Anatomic success of any associated posterior repair procedure
timeFrame: 24 months post operative
measure: Anatomic success of any associated posterior repair procedure
timeFrame: 6 months
measure: Anatomic success of any associated posterior repair procedure
timeFrame: 12 months
measure: Anatomic success of any associated apical repair procedure
timeFrame: 6 months
measure: Anatomic success of any associated apical repair procedure
timeFrame: 12 months
measure: Anatomic success of any associated apical repair procedure
timeFrame: 24 months
measure: Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
timeFrame: 6 months
measure: Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
timeFrame: 12 months
measure: Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
timeFrame: 24months
measure: Change in PISQ-IR
timeFrame: 6 months
measure: Change in PISQ-IR
timeFrame: 12 months
measure: Change in PISQ-IR
timeFrame: 24 months
measure: Change in PFDI - 20
timeFrame: 24 months
measure: Change in PFDI-20
timeFrame: 12 months
Other outcomes:
measure: Complications of surgery as per the Clavien-Dindo classification system
timeFrame: Peri operative
Locations:
city: Cambridge
country: United Kingdom
facility: Department of Urogynaecology
state: Cambridgeshire
Study officials:
References: