A Community Intervention Study of Female Pelvic Floor Condition and Knowledge of Pelvic Floor Exercises

November 4, 2015 updated by: University Hospital Plymouth NHS Trust
The aims of the study were to attempt to answer the following questions; what proportion of women know how to and are able to exercise their pelvic floor and for those who cannot can they be trained and motivated to do so. This was a nested design comprising a prospective cohort study together with a controlled trial intervention after baseline assessment in the cohort study for a defined at-risk group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Plymouth Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Able to give consent Aged above 18 years modified Oxford score, MOS, ≤ 2

Exclusion Criteria:

Unable to give consent

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nurse specialist
Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months.
Behavioral: Training
Women in both the practice nurse and specialist nurse groups were given supervised pelvic floor exercise training. After the initial training they were given a daily exercise regimen and seen at monthly intervals for three months. The practice nurses had attended a study day on supervising Pelvic Floor Muscle Training(PFMT)followed by practice sessions with patients overseen by the nurse specialist.
Other Names:
  • Pelvic Floor Muscle Training (PFMT)
Experimental: practice nurse
Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months.
Behavioral: Training
Women in both the practice nurse and specialist nurse groups were given supervised pelvic floor exercise training. After the initial training they were given a daily exercise regimen and seen at monthly intervals for three months. The practice nurses had attended a study day on supervising Pelvic Floor Muscle Training(PFMT)followed by practice sessions with patients overseen by the nurse specialist.
Other Names:
  • Pelvic Floor Muscle Training (PFMT)
No Intervention: Control
Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment (but no training given) and were followed-up for their final assessment at 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximal vaginal squeeze pressure (perineometry).
Time Frame: monthly for 3 months
monthly for 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
endurance of contraction (perineometry)and digital vaginal palpation (MOS).
Time Frame: monthly for 3 months
monthly for 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Plymouth NHS Trust

Investigators

  • Principal Investigator: Robert Freeman, MD, University Hospital Plymouth NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1706
  • Wellbeing of Women (OTHER: RG957)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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