Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02345538
Study type Observational
Source Duke University
Contact
Status Withdrawn
Phase N/A
Completion date November 2015

See also
  Status Clinical Trial Phase
Completed NCT03740932 - Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
Completed NCT04077801 - Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Recruiting NCT03868137 - Multi-dose Ibuprofen Prophylaxis for IUD-insertion N/A
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Completed NCT02547857 - Transvaginal Pelvic Ultrasound in the ED N/A
Completed NCT02923245 - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound N/A
Completed NCT01938092 - Vaginal Diazepam for the Treatment of Female Pelvic Pain Phase 2
Active, not recruiting NCT01731470 - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) N/A
Completed NCT01421641 - Tenaculum Pain Control Study Phase 4
Completed NCT00034047 - Endometriosis : Traditional Medicine vs Hormone Therapy Phase 1/Phase 2
Completed NCT05368155 - Chronic Pelvic Pain and Education Skills Training for Women Veterans N/A
Completed NCT04179149 - Enriched Environments in Endometriosis N/A
Not yet recruiting NCT05530681 - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth N/A
Completed NCT04077775 - Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
Completed NCT03715777 - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain Phase 3
Recruiting NCT05926752 - Photobiomodulation for Myofascial Pelvic Pain N/A
Completed NCT02588885 - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention N/A
Completed NCT02261740 - Program to Overcome Pelvic Pain With Yoga N/A