Pelvic PainNCT01669694
Pelvic Floor Physical Therapy-Biomarkers Project
An observational study of Pelvic Pain, run by Kenneth Peters, MD at 1 site in United States.
Trial summary
This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Pelvic floor PT with biomarkers
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2013
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.
Who may be able to join
- Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.
Who cannot join
- all others
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Women's Urology Center
Royal Oak, Michigan, 48073
About this study
Official title: Women's Urology Center-Physical Therapy-Biomarkers Project
This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points.
Read the detailed description
Collection points will be baseline, and at the last PT visit.
- Conditions
- Pelvic Pain
- Being tested
- Pelvic floor PT with biomarkers
- Keywords
- Pelvic Pain, Pelvic Floor Physical Therapy, Biomarkers
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor PT with biomarkersOther
Pelvic floor physical therapy and collection of urine for biomarker analysis.
| Study group | Role | What they receive |
|---|---|---|
| Women with Pelvic Pain | Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center Receives: Other: Pelvic floor PT with biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in biomarkers pre- and post-pelvic floor PT
Interim Analysis to be done as PI determines.
Measured: pre- and post- pelvic floor PT
Secondary outcomes (1)
Evaluation of biomarkers in relation to clinical findings
Clinical data and biomarkers will be analyzed.
Measured: pre- and post- pelvic floor PT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
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.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Donna J Carrico, NP, MS, Principal investigator, Corewell Health EastKenneth Peters, MD, Study chair, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669694
- Sponsor's protocol ID
- 2011-317
- Status last verified
- Oct 2015
- First submitted
- 19 Jul 2012
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Urology Center-Physical Therapy-Biomarkers Project
- ClinicalTrials.gov ID
- NCT01669694
- Acronym / sponsor ID
- 2011-317
- Conditions
- Pelvic Pain
- Keywords
- Pelvic Pain, Pelvic Floor Physical Therapy, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Aug 2012 (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.
This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points.
Detailed description
Collection points will be baseline, and at the last PT visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Pelvic Pain | – | Other: Pelvic floor PT with biomarkersWomen with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.
Key inclusion criteria (1 listed)
- Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.
Key exclusion criteria (1 listed)
- all others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor PT with biomarkersPelvic floor physical therapy and collection of urine for biomarker analysis. | Other | Women with Pelvic Pain |
Primary outcome
The change in biomarkers pre- and post-pelvic floor PT
Time frame: pre- and post- pelvic floor PT
Interim Analysis to be done as PI determines.
1 secondary outcome
Evaluation of biomarkers in relation to clinical findings
Time frame: pre- and post- pelvic floor PT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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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.
Donna J Carrico, NP, MS principal investigator
Corewell Health East
Kenneth Peters, MD study chair
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain, run by Kenneth Peters, MD at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in biomarkers pre- and post-pelvic floor PT (time frame: pre- and post- pelvic floor PT). 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 15 Oct 2015.