We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pelvic Floor Physical Therapy-Biomarkers Project

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669694
First Posted: August 21, 2012
Last Update Posted: October 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
  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:


Further study details as provided by Kenneth Peters, MD, 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
Women with Pelvic Pain
Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center
Other: Pelvic floor PT with biomarkers
Pelvic floor physical therapy and collection of urine for biomarker analysis.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 19, 2012
First Posted: August 21, 2012
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by Kenneth Peters, MD, William Beaumont Hospitals:
Pelvic Pain
Pelvic Floor Physical Therapy
Biomarkers

Additional relevant MeSH terms:
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms


To Top