Back to resultsMuscle Fiber Fragment Treatment for Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous Muscle Fiber Fragments
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, muscle fibers
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
- 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
Sites / Locations
- Wake Forest Urology ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous Muscle Fiber Fragments
Arm Description
Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region
Outcomes
Primary Outcome Measures
Incidence of treatment-related serious adverse events
the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization
Secondary Outcome Measures
Change in Incontinence Assessment by Pad Test
Subjects will undergo 1 hour and 24 hour Pad Tests (pads are weighed) at baseline, 3, 6 and 12 months post treatment
Full Information
NCT ID
NCT01953263
First Posted
September 25, 2013
Last Updated
June 2, 2023
Sponsor
Wake Forest University
1. Study Identification
Unique Protocol Identification Number
NCT01953263
Brief Title
Muscle Fiber Fragment Treatment for Urinary Incontinence
Official Title
A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, muscle fibers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous Muscle Fiber Fragments
Arm Type
Experimental
Arm Description
Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region
Intervention Type
Other
Intervention Name(s)
Autologous Muscle Fiber Fragments
Intervention Description
Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region
Primary Outcome Measure Information:
Title
Incidence of treatment-related serious adverse events
Description
the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Incontinence Assessment by Pad Test
Description
Subjects will undergo 1 hour and 24 hour Pad Tests (pads are weighed) at baseline, 3, 6 and 12 months post treatment
Time Frame
baseline, 3, 6, and 12 months post-treatment
Other Pre-specified Outcome Measures:
Title
Change in number of incontinence episodes and pads used per day
Description
voiding diaries and pads used each day will be compared to baseline
Time Frame
baseline, 3, 6 and 12 months post-treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary-Clare Day, RN, BSN
Phone
336-713-1343
Email
mday@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gopal Badlani, MD
Email
gbadlani@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gopal Badlani, MD
Organizational Affiliation
Wake Forest School of Medicine, Dept. of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Urology Clinic
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary-Clare Day, RN, BSN
Phone
336-713-1343
Email
mday@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Gopal Badlani, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Muscle Fiber Fragment Treatment for Urinary Incontinence
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