PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)

Pelvic Organ Prolapse Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136889
• Other study ID #: RG957
• Secondary ID: Wellbeing of Wom
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: January 18, 2011
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• PFMT
Women who have been successfully fitted with a vaginal pessary will be asked to attend five outpatient appointments over a 16 week period with a trained specialist women's health physiotherapist.

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Falkirk and District Royal Infirmary	Falkirk
United Kingdom	Southern General Hospital	Glasgow
United Kingdom	Victoria Infirmary	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Glasgow Caledonian University	NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolapse symptom score (POP-SS)		7 months	No
Secondary	Prolapse-related quality of life(single item scored 0 to 10)		7 months	No
Secondary	Prolapse severity (POP-Q)		7 months	No
Secondary	Urinary, bowel and sexual symptoms		7 months	No
Secondary	Lifestyle changes		7 months	No
Secondary	General Health Status		7 months	No
Secondary	Recurrence of prolapse symptoms over the one month period between removal of the pessary (month 6) and gynaecology clinic review (month 7)		7 months	No
Secondary	Time without pessary (i.e. time from removal of pessary to pessary being re-fitted)		7 months	No
Secondary	Need for further prolapse treatment including continuing use of pessary, PFMT or surgery.		7 months	No