Pelvic Floor Physical Therapy-Biomarkers Project | NCT01669694

Studies
Pelvic Floor Physical Therapy-Biomarkers Project

NCT01669694

Sponsor

Kenneth Peters, MD

Status

Completed

Last Update Posted

Oct 15, 2015Estimated

Enrollment

59Actual

Phase

Not provided

Conditions

Pelvic Pain

Interventions

Pelvic floor PT with biomarkers

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Aug 16, 2012

First Posted Date

Aug 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2015

Last Update Posted Date

Oct 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pelvic floor PT with biomarkers	Other	Pelvic floor physical therapy and collection of urine for biomarker analysis.	Women with Pelvic Pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donna J Carrico, NP, MS	Corewell Health East	Principal Investigator
Kenneth Peters, MD	Corewell Health East	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beaumont Women's Urology Center		Royal Oak	Michigan	48073	United States

Condition Browse Module

MeSH Terms

ID	Term
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided