Clinical trial NCT02345538: Use of a Perineometer to Assess Pelvic Muscle Tone
Official title: Use of a Perineometer to Assess Resting Pelvic Muscle Tone in Patients With Pelvic Pain
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pelvic Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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).

Primary outcomes:
measure: measurement of pelvic pressure in the two groups
timeFrame: 1 day
Secondary outcomes:
measure: Brinks score
timeFrame: 1 day
measure: Pelvic pain score
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Nazema Siddiqui, MD
role: PRINCIPAL_INVESTIGATOR
References: