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Pelvic Floor Physical Therapy-Biomarkers Project - Full Text ... https://clinicaltrials.

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Pelvic Floor Physical Therapy-Biomarkers Project

This study has been completed. ClinicalTrials.gov Identifier:


NCT01669694
Sponsor:
Kenneth Peters, MD First received: July 19, 2012
Last updated: October 13, 2015
Information provided by (Responsible Party): Last verified: October 2015
Kenneth Peters, MD, William Beaumont Hospitals History of Changes

Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record

Purpose

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.

Condition Intervention

Pelvic Pain Other: Pelvic floor PT with biomarkers

Study Type: Observational


Study Design: Observational Model: Cohort
Time Perspective: Prospective

Official Title: Women's Urology Center-Physical Therapy-Biomarkers Project

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup Pelvic Pain

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:


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.

Secondary Outcome Measures:


Evaluation of biomarkers in relation to clinical findings [ Time Frame: pre- and post- pelvic floor PT ]
Clinical data and biomarkers will be analyzed.

Biospecimen Retention: Samples With DNA


serum and urine

Enrollment: 59
Study Start Date: October 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions

1 of 3 2/12/17, 5:52 PM
Pelvic Floor Physical Therapy-Biomarkers Project - Full Text ... https://clinicaltrials.gov/ct2/show/study/NCT01669694

Women with Pelvic Pain Other: Pelvic floor PT with biomarkers


Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Pelvic floor physical therapy and collection of urine for
Urology Center biomarker analysis.

Detailed Description:
Collection points will be baseline, and at the last PT visit.

Eligibility

Ages Eligible for Study: 18 Years to 100 Years (Adult, Senior)


Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population
Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.

Criteria

Inclusion Criteria:
Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.
Exclusion Criteria:
all others

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669694

Locations

United States, Michigan

Beaumont Women's Urology Center


Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

Kenneth Peters, MD

Investigators

Principal Investigator: Donna J Carrico, NP, MS William Beaumont Hospitals


Study Chair: Kenneth Peters, MD William Beaumont Hospitals

More Information

Responsible Party: Kenneth Peters, MD, Investigator, William Beaumont Hospitals


ClinicalTrials.gov Identifier: NCT01669694 History of Changes
Other Study ID Numbers: 2011-317
Study First Received: July 19, 2012
Last Updated: October 13, 2015

Keywords provided by William Beaumont Hospitals:


Pelvic Pain
Pelvic Floor Physical Therapy
Biomarkers

Additional relevant MeSH terms:


Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 10, 2017

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Pelvic Floor Physical Therapy-Biomarkers Project - Full Text ... https://clinicaltrials.gov/ct2/show/study/NCT01669694

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