Use of a Perineometer to Assess Pelvic Muscle Tone

NCT02345538 | Withdrawn

• 1 other identifier: Pro00053004
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• measurement of pelvic pressure in the two groups

  using the peritron device at rest and maximum squeeze

  1 day

Secondary Outcomes (2)

• Brinks score

  1 day

• Pelvic pain score

  1 day

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nazema Siddiqui, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 26, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share