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Use of a Perineometer to Assess Pelvic Muscle Tone

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ClinicalTrials.gov Identifier: NCT02345538
Recruitment Status : Withdrawn (Investigator did not start the project in time; study team decided it was not feasible to begin study as resident was soon graduating. No patients enrolled.)
First Posted : January 26, 2015
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to establish the range of pelvic floor pressure in groups of women, including women with and without pelvic pain, and compare the change in perineometer measurements between rest and maximum pelvic floor contraction in women with and without pelvic pain. Purpose is also to determine whether resting pelvic floor perineometer measurements correlate with the severity of pain symptoms in women with chronic pelvic pain.

Condition or disease
Pelvic Pain

Detailed Description:

Chronic pelvic pain (CPP) is defined as non-cyclic pelvic pain lasting at least 6 months. Approximately 3-15% of women are affected by CPP. Care of patients with CPP contributes to considerable healthcare costs, accounting for 880 million dollars annually in outpatient visits alone. Although CPP may be multifactorial, many women have a contribution from increased pelvic floor tone. CPP due to increased pelvic floor tone is usually referred to as levator spasm or high tone pelvic floor dysfunction. Levator tenderness and increased pelvic tone may be identified on physical exam. However, physical exam is somewhat subjective and may vary based on the clinician performing the exam. There are currently no validated, objective measures to judge resting pelvic tone, which 1) limits objective assessment in research studies and 2) limits our ability to assess response to new treatment modalities.

The ability to contract the pelvic floor may be assessed during pelvic exam with a Brink's score. However, there are still elements of subjectivity in components of this score and researchers continue to look for an objective measure of pelvic floor muscle tone. The Peritron perineometer device has been shown to correlate well with pelvic floor contraction, based on Brinks scores.Measurements taken with the Peritron device have better inter-rater reliability than other measures of pelvic floor contraction, which makes it an attractive tool for clinical research. However, its use in clinical research is hampered by the lack of normative data with perineometer measurements. Though there are some studies that use the perineometer to assess resting (i.e. non-contracted) pelvic tone after therapies for pelvic pain, there are no studies that assess the typical perineometer measurements in women with levator spasm, and there are no data to guide how these measurements may compare with women having a normal pelvic floor examination. We hypothesize that: 1) Women with high resting pelvic tone perceived on exam will have high perineometer measurements and women with normal pelvic tone on exam will have low perineometer measurements, regardless of whether or not they report pelvic pain. 2) Women with high resting perineometer measurements will have minimal change in perineometer scores between resting and maximum pelvic floor contraction (squeeze). 3) In women with clinical evidence of levator spasm, resting perineometer measurements will correlate with severity of pelvic pain symptoms. We plan to investigate these hypotheses by executing the following specific aims:

Specific Aim 1: To compare clinical assessment of resting pelvic tone with perineometer measurements in a range of women, including those with and without pelvic pain.

Specific Aim 2: To compare the change in perineometer measurements between rest and maximum pelvic floor contraction in women with and without pelvic pain.

Specific Aim 3: To determine whether resting pelvic floor perineometer measurements correlate with the severity of pain symptoms, as measured by short form McGill questionnaire scores and visual analog scale (VAS), in a subset of women with pelvic pain and clinical evidence of levator spasm.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of a Perineometer to Assess Resting Pelvic Muscle Tone in Patients With Pelvic Pain
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Group/Cohort
Women with Chronic Pelvic Pain
Use of perineometer to measure pelvic resting tone and contraction in women with chronic pelvic pain and determine if resting tone correlates with severity of pain.
Women without Chronic Pelvic Pain
Use of perineometer to measure pelvic resting tone and contraction in women without chronic pelvic pain



Primary Outcome Measures :
  1. measurement of pelvic pressure in the two groups [ Time Frame: 1 day ]
    using the peritron device at rest and maximum squeeze


Secondary Outcome Measures :
  1. Brinks score [ Time Frame: 1 day ]
    measurement of maximum kegel strength on clinical exam

  2. Pelvic pain score [ Time Frame: 1 day ]
    quantification of pelvic pain based on visual analog score and short form McGill pain questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A group of adult women, seen in an outpatient urogynecology or minimally invasive gynecology clinic, including women with and without pelvic pain.
Criteria

Inclusion Criteria:

  • being seen in the Duke Urogynecology or Minimally Invasive Gynecology Clinics

Exclusion Criteria:

  • botulinum toxin A injection into bladder or pelvic floor musculature within the prior 9 months
  • history of GYN or GU malignancy
  • chronic use of muscle relaxants
  • exam findings that would preclude the ability of the woman to retain the Peritron device (e.g. narrowed introitus or stage III/IV prolapse).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345538


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Nazema Siddiqui, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02345538    
Other Study ID Numbers: Pro00053004
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: study withdrawn
Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms