A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse

Summary

Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other organs moving down from their normal position in the pelvis and pushing into the vagina. This is a very common problem and many women who have given birth will have a very mild bulge which does not cause them symptoms. Women can however experience a variety of pelvic, bladder, bowel and sexual symptoms which impact on daily life. No research studies have properly examined whether or not exercises can prevent prolapse. This study aims to explore whether exercises taught by a physiotherapist can prevent women developing a prolapse which requires them to have treatment.

Conditions

• Pelvic Organ Prolapse

Interventions

OTHER

Pelvic Floor Muscle training

Women allocated to the intervention group will have five appointments with a specialist women's health physiotherapist (intervention physiotherapist) over 16 weeks who will prescribe a daily exercise programme and provide a Lifestyle Advice Sheet (focusing on weight loss, constipation, avoidance of heavy lifting, coughing and high-impact exercise) and relevant tailored advice (phase 1). Thereafter women in the intervention group will be offered Pilates-based classes, including PFMT, as maintenance (phase 2). Classes will be led by a physiotherapist who has undertaken Pilates training and will take place in six week blocks; each woman will be offered two six week blocks over a year. An exercise DVD will be provided for home use. Each woman will be offered a one-to-one review physiotherapy appointment at one and two years after randomisation.

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• Birmingham Women's NHS Foundation Trust

  collaborator OTHER_GOV

• University of Aberdeen

  collaborator OTHER

• Aberdeen Royal Infirmary

  collaborator OTHER

• University of Otago

  collaborator OTHER

• Glasgow Caledonian University

  lead OTHER

Principal Investigators

• Prof Hagen, PhD MSc BSc CStat CSci · NMAHP Research Unit

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• New Zealand
• United Kingdom

Study Locations