RECRUITING

Muscle Fiber Fragment Treatment for Urinary Incontinence

Conditions

Urinary Incontinence urinary incontinence, muscle fibers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Official Title

A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence

Quick Facts

Study Start:2016-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01953263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator * Patients between the ages of 18 and 75 years * Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions. * Patients with cystometric capacity of bladder \> 100 ml * Patients with normal renal function * Patients with a history of primary incontinence	* Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder * Patients with an active urinary tract infection as evidenced by positive urine culture * Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas * Patients requiring concomitant use of or treatment with immunosuppressive agents * Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study * Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy) * Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study * Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study * Patients with urinary incontinence other than the categories being investigated * Patients with significant (\>grade 2) pelvic organ prolapse * Patients with vaginal prolapse beyond introitus * Patients with neurological disorders * Patients with abnormal bladder capacity (i.e., less than 100 cc) * Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment

Inclusion Criteria

Exclusion Criteria

* Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator
* Patients between the ages of 18 and 75 years
* Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions.
* Patients with cystometric capacity of bladder \> 100 ml
* Patients with normal renal function
* Patients with a history of primary incontinence

* Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder
* Patients with an active urinary tract infection as evidenced by positive urine culture
* Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas
* Patients requiring concomitant use of or treatment with immunosuppressive agents
* Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study
* Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)
* Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study
* Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study
* Patients with urinary incontinence other than the categories being investigated
* Patients with significant (\>grade 2) pelvic organ prolapse
* Patients with vaginal prolapse beyond introitus
* Patients with neurological disorders
* Patients with abnormal bladder capacity (i.e., less than 100 cc)
* Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment

Contacts and Locations

Study Contact

Mary-Clare Day, RN, BSN

CONTACT

336-713-1343

mday@wakehealth.edu

Gopal Badlani, MD

CONTACT

gbadlani@wakehealth.edu

Principal Investigator

Gopal Badlani, MD

PRINCIPAL_INVESTIGATOR

Wake Forest School of Medicine, Dept. of Urology

Study Locations (Sites)

Wake Forest Urology Clinic

Winston-Salem, North Carolina, 27103

United States

Collaborators and Investigators

Sponsor: Wake Forest University

Gopal Badlani, MD, PRINCIPAL_INVESTIGATOR, Wake Forest School of Medicine, Dept. of Urology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2016-01

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

urinary incontinence, muscle fibers

Additional Relevant MeSH Terms

Urinary Incontinence