Clinical Trial: PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

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 Summary:

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 immediat
Sponsor: Glasgow Caledonian University

Current Primary Outcome: Prolapse symptom score (POP-SS) [ Time Frame: 7 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prolapse-related quality of life(single item scored 0 to 10) [ Time Frame: 7 months ]
  • Prolapse severity (POP-Q) [ Time Frame: 7 months ]
  • Urinary, bowel and sexual symptoms [ Time Frame: 7 months ]
  • Lifestyle changes [ Time Frame: 7 months ]
  • General Health Status [ Time Frame: 7 months ]
  • Recurrence of prolapse symptoms over the one month period between removal of the pessary (month 6) and gynaecology clinic review (month 7) [ Time Frame: 7 months ]
  • Time without pessary (i.e. time from removal of pessary to pessary being re-fitted) [ Time Frame: 7 months ]
  • Need for further prolapse treatment including continuing use of pessary, PFMT or surgery. [ Time Frame: 7 months ]


Original Secondary Outcome: Same as current

Information By: Glasgow Caledonian University

Dates:
Date Received: June 2, 2010
Date Started: April 2008
Date Completion:
Last Updated: January 18, 2011
Last Verified: January 2011