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Completed

NCT Number: NCT00476892

Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse

The aim of this study is to determine the effectiveness and cost-effectiveness of pelvic floor muscle training in the management of pelvic organ prolapse in women.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St George Hospital, Sydney, Australia

Loading trial locations.

About this study

Pelvic organ prolapse is a common problem that adversely affects the daily activities and quality of life of many women. Pelvic floor muscle training interventions are commonly used by physiotherapists to manage prolapse. However, a Cochrane review found limited evidence to support the effectiveness of such interventions. Based on the findings of a successful feasibility study, this multi-centre randomised controlled trial will address the paucity of evidence. 556 symptomatic women with diagnosed prolapse will be enrolled in 16 UK centres and 1 New Zealand centre over 16 months and randomised to pelvic floor muscle training plus lifestyle advice, or to receive a lifestyle leaflet only. Principal measures of outcome are: prolapse symptoms, prolapse severity, and subsequent further treatment up to 12 months after trial entry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New attendee at outpatient gynaecology clinic
  • Any type of prolapse

Exclusion criteria

  • Stage 0 or IV prolapse
  • Women reporting no symptoms of prolapse
  • Previous treatment for prolapse (surgery or formal instruction in Pelvic Floor Muscle Training [PMFT,]unless completed more than 5 years ago, pessary, unless pessary removed more than 12 months ago)
  • Unable to comply with PFMT
  • women who have urogenital atrophy requiring treatment with local oestrogens (after an 8 week course of local oestrogen such women can be included);
  • Pregnant or less than 6 months post-natal
  • Unable to give informed consent

Treatment and study plan

pelvic floor muscle training

Procedure

Women in the intervention group attend 5 physiotherapy sessions. At each appointment a clinical history is taken, pelvic floor muscle assessment carried out, exercises taught and prescribed, and appropriate lifestyle advice given. At the first of these appointments a detailed explanation of the pelvic anatomy and different types of prolapse is given.

Primary outcomes

  1. Prolapse symptom score (questions developed in feasibility study and undergoing validation). Primary economic outcome measures are: use of health services, average number of days of prolapse symptoms and further prolapse treatment needed/received

    Time frame: 1 year

Secondary outcomes

  1. Prolapse-related quality of life, prolapse severity, need for further prolapse treatment. Other outcomes include: lifestyle changes, urinary symptoms, bowel symptoms, sexual symptoms, general health status.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • South Glasgow University Hospitals NHS Trust
  • University of Aberdeen
  • University of Otago

Registry information

Official study title

A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse

Acronym: POPPY

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
May 22, 2007
Registry last updated
Mar 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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