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Mitigating Chronic Pelvic Floor Dysfunction Following Childbirth by Pelvic Floor Dynamometry

NCT02391285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2016-04-14

No results posted yet for this study

Summary

To assess the potential clinical utility of measuring pelvic floor muscle tone after childbirth by vaginal dynamometry, the investigators will study 50 consecutive consenting first attendees of the Jessop Wing perineal trauma clinic. In addition to clinical and imaging assessment routinely offered women at this clinic, the investigators will measure their active and passive pelvic floor muscle tone using the Auckland vaginal elastometer. The investigators will also assess structural pelvic floor muscle damage (PFMD) in a subset of 10 women (5 symptomatic and 5 asymptomatic) by Magnetic Resonance Imaging (MR) scan of the pelvic hiatus. The investigators will then determine the predictive capacity of vaginal elastometry for symptoms of pelvic floor damage, findings of endoanal sonography, and MR scans of the pelvic floor hiatus. The investigators will determine if vaginal elastometry can prove an objective and accurate frontline assessment tool for the management of PFMD following childbirth. Our observations will generate vital data for powering and designing a large clinical trial evaluating the potential use of the vaginal elastometer as a first line assessment tool of PFMD in the postnatal period. Data will also inform the design of a personalised model for predicting and managing pelvic floor muscle damage during childbirth.

Conditions

  • Pelvic Floor Dysfunction

Interventions

DEVICE

dynamometer (Auckland vaginal elastometer)

The elastometer is a modified vaginal speculum which captures pelvic muscle tone over 3 minutes and records this on an attached computer. In addition to the elastometer test, there are three further related tests, which patients would be suitable to participate in. I. a questionnaire to fill in so as to obtain some feedback from patients regarding what they thought of the test and the device. II. The investigators would like to repeat the elastometer measurement within a week of the first test to determine the reliability and accuracy of repeating the measurement after a few days. III. The investigator would like to request that the patient have an MRI scan of the pelvic muscles to check whether the elastometer can pick up functional muscle weakness that would not otherwise be recognised except by performing an MRI scan. The investigators will therefore compare elastometer readings to the MRI scan findings.

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT02391285 on ClinicalTrials.gov