NCT01669694

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

July 19, 2012

Last Update Submit

October 13, 2015

Conditions

Pelvic Pain

Keywords

Pelvic PainPelvic Floor Physical TherapyBiomarkers

Outcome Measures

Primary Outcomes (1)

  • The change in biomarkers pre- and post-pelvic floor PT

    Interim Analysis to be done as PI determines.

    pre- and post- pelvic floor PT

Secondary Outcomes (1)

  • Evaluation of biomarkers in relation to clinical findings

    pre- and post- pelvic floor PT

Study Arms (1)

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

Interventions

Pelvic floor PT with biomarkersOTHER

Pelvic floor physical therapy and collection of urine for biomarker analysis.

Women with Pelvic Pain

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • all others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Women's Urology Center

Royal Oak, Michigan, 48073, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and urine

MeSH Terms

Conditions

Pelvic Pain

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Donna J Carrico, NP, MS

    Corewell Health East

    PRINCIPAL INVESTIGATOR

  • Kenneth Peters, MD

    Corewell Health East

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

July 19, 2012

First Posted

August 21, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

US(1)