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

NCT ID: NCT01635894

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Behavioural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pelvic Floor Muscle Training (PFMT)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Unable to give consent

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Plymouth NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Freeman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Plymouth NHS Trust

Locations

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Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Site Status

Countries

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United Kingdom

References

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Waterfield A, Waterfield M, Campbell J, Freeman R. Can effective supervised pelvic floor muscle training be provided by primary care nurses? A randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2717-2725. doi: 10.1007/s00192-021-04692-3. Epub 2021 Feb 23.

Reference Type DERIVED
PMID: 33624122 (View on PubMed)

Other Identifiers

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WellBeing of Women

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1706

Identifier Type: -

Identifier Source: org_study_id

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