Pelvic PainNCT02345538
Use of a Perineometer to Assess Pelvic Muscle Tone
An observational study of Pelvic Pain, run by Duke University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A group of adult women, seen in an outpatient urogynecology or minimally invasive gynecology clinic, including women with and without pelvic pain.
Who may be able to join
- being seen in the Duke Urogynecology or Minimally Invasive Gynecology Clinics
Who cannot join
- 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).
About this study
Official title: Use of a Perineometer to Assess Resting Pelvic Muscle Tone in Patients With Pelvic Pain
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.
Read the 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.
- Conditions
- Pelvic Pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of pelvic pressure in the two groups
using the peritron device at rest and maximum squeeze
Measured: 1 day
Secondary outcomes (2)
Brinks score
measurement of maximum kegel strength on clinical exam
Measured: 1 day
Pelvic pain score
quantification of pelvic pain based on visual analog score and short form McGill pain questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazema Siddiqui, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345538
- Sponsor's protocol ID
- Pro00053004
- Status last verified
- Jun 2016
- First submitted
- 20 Jan 2015
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: study withdrawn
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Perineometer to Assess Resting Pelvic Muscle Tone in Patients With Pelvic Pain
- ClinicalTrials.gov ID
- NCT02345538
- Acronym / sponsor ID
- Pro00053004
- Conditions
- Pelvic Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A group of adult women, seen in an outpatient urogynecology or minimally invasive gynecology clinic, including women with and without pelvic pain.
Key inclusion criteria (1 listed)
- being seen in the Duke Urogynecology or Minimally Invasive Gynecology Clinics
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measurement of pelvic pressure in the two groups
Time frame: 1 day
using the peritron device at rest and maximum squeeze
2 secondary outcomes
Brinks score
Time frame: 1 day
Pelvic pain score
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Individual participant dataSharing planned: No. study withdrawn
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazema Siddiqui, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of pelvic pressure in the two groups (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.