Pelvic Floor Physical Therapy-Biomarkers Project

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01669694
First received: July 19, 2012
Last updated: October 13, 2015
Last verified: October 2015
  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 William Beaumont Hospitals:

Primary Outcome Measures:
  • The change in biomarkers pre- and post-pelvic floor PT [ Time Frame: pre- and post- pelvic floor PT ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders 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
Health Authority: United States: Institutional Review Board

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 July 27, 2016