Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Kenneth Peters, MD2 sites in 1 country1 target enrollmentOctober 2011

ConditionsStress Urinary Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stress Urinary Incontinence
Sponsor: Kenneth Peters, MD
Enrollment: 1
Locations: 2
Primary Endpoint: Study-Related Adverse Events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

Detailed Description

Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Kenneth Peters, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Kenneth Peters, MD

Principal Investigator

William Beaumont Hospitals

Eligibility Criteria

Inclusion Criteria

•urinary incontinence
•failed urinary incontinence (UI) treatments

Exclusion Criteria

•does not meet inclusion criteria, gender and age limit

Outcomes

Primary Outcomes

Study-Related Adverse Events

Time Frame: 6 months

Secondary Outcomes

Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire(Baseline and 6 months)
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)(6 months)
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)(6 months)