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临床试验/NCT02345538
NCT02345538撤回不适用

Use of a Perineometer to Assess Resting Pelvic Muscle Tone in Patients With Pelvic Pain

Duke University0 个研究点开始时间: 2015年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
measurement of pelvic pressure in the two groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

measurement of pelvic pressure in the two groups

时间窗: 1 day

using the peritron device at rest and maximum squeeze

次要结局

  • Brinks score(1 day)
  • Pelvic pain score(1 day)

研究者

申办方类型
Other
责任方
Sponsor

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