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CompletedNCT01635894Updated Nov 5, 2015

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

An interventional study of Training in Behavioural, sponsored by University Hospital Plymouth NHS Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-05.

Sponsored by University Hospital Plymouth NHS Trust · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

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.

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Conditions studied

  • Behavioural

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Keywords

  • female pelvic floor condition
  • pelvic floor training
  • supervised pelvic floor training
  • practice nurse
  • nurse specialist
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In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 240 is above the median of 80 across 732 interventional studies indexed under Disease.

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Lead sponsor

University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Unable to give consent

-

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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • 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

  • 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

  • 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.

Interventions

  • BehavioralTraining

    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.

    Also known as: Pelvic Floor Muscle Training (PFMT)

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What researchers measure

Primary outcomes

  1. maximal vaginal squeeze pressure (perineometry).

    Time frame: monthly for 3 months

Secondary outcomes

  1. endurance of contraction (perineometry)and digital vaginal palpation (MOS).

    Time frame: monthly for 3 months

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Study locations

1 site
  • Plymouth Hospitals NHS Trust
    Plymouth, Devon PL6 8DH, United Kingdom
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References and documents

Publications

  • 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. PubMed 33624122 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01635894
Lead sponsor
University Hospital Plymouth NHS Trust
Responsible party
Sponsor
First posted
Jul 10, 2012
Start date
Apr 2002
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Nov 5, 2015

Study contacts

Robert Freeman, MD
principal investigator · University Hospital Plymouth NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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