Clinical trial NCT01136889: PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)
Official title: A Feasibility Study for a Randomised Controlled Trial of Pelvic Floor Muscle Training Combined With Vaginal Pessary for Women With Pelvic Organ Prolapse.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: PFMT
Vaginal pessary
Pelvic Organ Prolapse
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2010-06-04
Enrollment: 16
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To determine the feasibility of conducting a randomised controlled trial (RCT) of the effectiveness of a PFMT intervention in conjunction with vaginal pessary management versus vaginal pessary management alone for women with pelvic organ prolapse.
2. To develop and test the methods for a main trial.

The ultimate aim of a large multi-centre RCT would be to answer the question:

Is conservative management of pelvic organ prolapse with an individualised PFMT intervention in conjunction with vaginal pessary more effective than vaginal pessary alone in reducing prolapse-specific symptoms, prolapse severity and the need for further prolapse treatment?

Detailed description: It is hypothesised that undertaking PFMT with a pessary in place may increase the level of existing muscle support in the pelvic area: by reducing the descent of the pelvic organs and the consequent stretching of soft tissue the pessary may allow the pelvic floor muscles to be exercised and strengthened more effectively. Potentially this could lead to additional improvements in the pessary retention rate and associated prolapse symptoms beyond that expected from the pessary alone. Urine, bowel and sexual function, which can be affected by prolapse, may also improve independently in response to a PFMT intervention. If a more permanent reduction in prolapse symptoms results from concurrent use of PFMT, this may delay or prevent the need for long term pessary use or surgical intervention. In summary, a PFMT intervention in combination with pessary management for vaginal prolapse may be more effective in reducing symptoms and increasing quality of life than management of the prolapse with a pessary alone. This study will start to provide the evidence to address this question.

This is a feasibility study to develop the methods for a multi-centre RCT. It will run alongside The POPPY Trial (a 17 centre trial of PFMT already underway in the UK; ClinicalTrials Number NCT00476892). Three of The POPPY Trial centres will be involved in this feasibility study. Over a 12 month period, we plan to enrol 50 women with diagnosed prolapse of stage I to IV, who are not eligible for The POPPY Trial because they require a pessary. These women will be randomised into one of two groups: PFMT (delivered by a physiotherapist at 5 appointments over 16 weeks) in conjunction with pessary management of their prolapse or pessary management alone. All women will have a nurse appointment six months after randomisation at which time their pessary will be removed. A replacement pessary will not be immediately re-fitted. At seven months after randomisation all women will have a review appointment with their gynaecologist to have their prolapse assessed, the pessary re-fitted if necessary, and other treatment needs discussed. Women will complete postal questionnaires, at baseline (prior to randomisation), at six months post-randomisation (prior to seeing the nurse to have the pessary removed), and seven months post-randomisation (prior to the 7 month gynaecologist review appointment), and record symptoms in a diary for one month after removal of the pessary. Key outcomes are: prolapse symptoms, prolapse-related quality of life, prolapse severity, and additional prolapse treatment received up to seven months after study entry.

Eligibility criteria: Inclusion Criteria:

Women:

* who are new attendees at outpatient gynaecology clinics with a primary complaint of prolapse;
* who have a prolapse of stage I to IV confirmed by their gynaecologist using the POP-Q grading system;
* who have a prolapse of one or more of the following types:
* anterior vaginal wall prolapse (urethrocele, cystocele,paravaginal defect);
* uterine/cervical prolapse;
* vaginal vault (after hysterectomy)prolapse;
* posterior vaginal wall prolapse (enterocele, rectocele, perineal deficiency);
* who require a vaginal pessary for treatment of their prolapse (the process of fitting the pessary will be according to standard practice at the centre thus the protocol for choice of pessary, insertion and follow-up will be determined locally);
* who successfully retain the vaginal pessary for two weeks after fitting;
* who are willing to participate in the study and to comply with their group allocation.

Exclusion Criteria:

Women:

* who wish surgical treatment for prolapse and wish to be immediately added to the surgical waiting list;
* who have had previous surgical treatment for prolapse;
* who have had a pessary fitted for treatment of prolapse within the last 12 months;
* who have had previous formal instruction in PFMT;
* who present with contraindications to either pessary or PFMT treatment;
* who are unable to comply with PFMT treatment;
* who have local atrophy (this must be treated first);
* who are less than 6-months postnatal;
* who are pregnant;
* who are unable to give informed consent.

Primary outcomes:
measure: Prolapse symptom score (POP-SS)
timeFrame: 7 months
Secondary outcomes:
measure: Prolapse-related quality of life(single item scored 0 to 10)
timeFrame: 7 months
measure: Prolapse severity (POP-Q)
timeFrame: 7 months
measure: Urinary, bowel and sexual symptoms
timeFrame: 7 months
measure: Lifestyle changes
timeFrame: 7 months
measure: General Health Status
timeFrame: 7 months
measure: Recurrence of prolapse symptoms over the one month period between removal of the pessary (month 6) and gynaecology clinic review (month 7)
timeFrame: 7 months
measure: Time without pessary (i.e. time from removal of pessary to pessary being re-fitted)
timeFrame: 7 months
measure: Need for further prolapse treatment including continuing use of pessary, PFMT or surgery.
timeFrame: 7 months
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Falkirk
country: United Kingdom
facility: Falkirk and District Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Glasgow
country: United Kingdom
facility: Victoria Infirmary
Study officials:
affiliation: NMAHP Research Unit
name: Professor Suzanne Hagen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.
citation: Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.