VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Success in anterior compartment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Unable to complete questionnaires due to poor level of english
- •Patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
Arms & Interventions
SPOP
This arm will have the soft silicone pessary inserted post operatively and it will remain in-situ for 3 weeks.
Intervention: Surgical Pelvic Organ Pessary (Other)
Non Intervention
Routine post operative care
Outcomes
Primary Outcomes
Success in anterior compartment.
Time Frame: 6 months post operative
Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba \<-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =\>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Success in Anterior Compartment
Time Frame: 24months post operative
Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba \<-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =\>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Success in Anterior Compartment
Time Frame: 12 months post operative
Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba \<-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =\>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Secondary Outcomes
- Division of vaginal band(6months)
- Change in POP-Q quantitative measurements from baseline(24 months)
- Anatomic success of any associated posterior repair procedure(12 months)
- Change in PISQ-IR(24 months)
- Change in PFDI-20(12 months)
- Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery(24months)
- Change in PFDI - 20(24 months)
- Anatomic success of any associated apical repair procedure(24 months)
- Change in POP-Q quantitative measurements from baseline(6 months)
- Change in POP-Q quantitative measurements from baseline(12 months)
- Anatomic success of any associated posterior repair procedure(24 months post operative)
- Anatomic success of any associated posterior repair procedure(6 months)
- Anatomic success of any associated apical repair procedure(6 months)
- Anatomic success of any associated apical repair procedure(12 months)
- Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery(6 months)
- Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery(12 months)
- Change in PISQ-IR(6 months)
- Change in PISQ-IR(12 months)
Investigators
Dr Ivilina Pandeva
Urogynaecology Subspecialist trainee
Cambridge University Hospitals NHS Foundation Trust