Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Other: Surgical Pelvic Organ Pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SPOP<br>This arm will have the soft silicone pessary inserted post operatively and it will remain in-situ for 3 weeks. | Other: Surgical Pelvic Organ Pessary<br>* In participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen.<br>|
| No Intervention: Non Intervention<br>Routine post operative care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in anterior compartment. | 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. | 6 months post operative | 
| Success in Anterior Compartment | 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. | 12 months post operative | 
| Success in Anterior Compartment | 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. | 24months post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in POP-Q quantitative measurements from baseline |  | 6 months | 
| Change in POP-Q quantitative measurements from baseline |  | 12 months | 
| Change in POP-Q quantitative measurements from baseline |  | 24 months | 
| Division of vaginal band | Any patient requiring repeat procedure for division vaginal band with in 6 months post operative. | 6months | 
| Anatomic success of any associated posterior repair procedure | Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination. | 24 months post operative | 
| Anatomic success of any associated posterior repair procedure | Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination. | 6 months | 
| Anatomic success of any associated posterior repair procedure | Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination. | 12 months | 
| Anatomic success of any associated apical repair procedure | Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination. | 6 months | 
| Anatomic success of any associated apical repair procedure | Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination. | 12 months | 
| Anatomic success of any associated apical repair procedure | Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination. | 24 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 | 
| Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery |  | 24months | 
| Change in PISQ-IR | Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised | 6 months | 
| Change in PISQ-IR | Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised | 12 months | 
| Change in PISQ-IR | Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised | 24 months | 
| Change in PFDI - 20 | Validated patient reported outcome (pelvic floor distress inventory) - | 24 months | 
| Change in PFDI-20 | Validated patient reported outcome (pelvic floor distress inventory) - | 12 months |