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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: Surgical Pelvic Organ Pessary

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom
      • Department of Urogynaecology
      • Contact: Miss Pandeva; Phone Number: 07971397396; Email: ivilina.pandeva@addenbrookes.nhs.uk
      • Contact: Mark C Slack; Email: mark.slack@addenbrookes.nhs.uk
      • Sub-Investigator: Ivilina Pandeva
      • Sub-Investigator: Felicity G Gould
      • Principal Investigator: Mark C Slack

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SPOP; 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; 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.
No Intervention: Non Intervention; Routine post operative care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Complications of surgery as per the Clavien-Dindo classification system	Peri operative

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: A094029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO