Pelvic Floor Physical Therapy-Biomarkers Project
This study is currently recruiting participants.
Verified December 2012 by William Beaumont Hospitals
Sponsor:
William Beaumont Hospitals
Information provided by (Responsible Party):
Donna Carrico, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01669694
First received: July 19, 2012
Last updated: December 21, 2012
Last verified: December 2012
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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
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2011 |
| 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 |
Detailed Description:
Collection points will be baseline, and at the last PT visit.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669694
Contacts
| Contact: Michelle L Romano, RN | 248-898-1259 | Michelle.Romano@beaumont.edu |
Locations
| United States, Michigan | |
| Beaumont Women's Urology Center | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Michelle L. Romano, RN Michelle.Romano@beaumont.edu | |
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
| Principal Investigator: | Donna J Carrico, NP, MS | William Beaumont Hospitals |
More Information
No publications provided
| Responsible Party: | Donna Carrico, WHNP, MS/PI, William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT01669694 History of Changes |
| Other Study ID Numbers: | 2011-317 |
| Study First Received: | July 19, 2012 |
| Last Updated: | December 21, 2012 |
| 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 Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013