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PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)

NCT01136889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-01-19

No results posted yet for this study

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?

Conditions

  • Pelvic Organ Prolapse

Interventions

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.

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • Glasgow Caledonian University

    lead OTHER

Principal Investigators

  • Professor Suzanne Hagen · NMAHP Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01136889 on ClinicalTrials.gov