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Muscle Fiber Fragment Treatment for Urinary Incontinence
Phase 1 & 2
Recruiting
Led By Gopal Badlani, MD
Research Sponsored by Wake Forest University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with cystometric capacity of bladder > 100 ml
Patients between the ages of 18 and 75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6 and 12 months post-treatment
Awards & highlights
Study Summary
This trial will test if a person's own muscle fibers can be used to treat urinary incontinence caused by a weak bladder neck or urethra.
Who is the study for?
This trial is for adult women aged 18-75 with urinary incontinence due to bladder neck or urethral issues. They must not be pregnant, breastfeeding, and should use birth control if sexually active. Participants need a bladder capacity over 100 ml and normal kidney function. Excluded are those with neurological disorders, muscle diseases, coagulation problems, significant pelvic organ prolapse, recent cellular therapy or investigational drug use.Check my eligibility
What is being tested?
The study tests the safety of autologous muscle fiber fragments as a treatment for urinary incontinence caused by sphincter insufficiency. It's aimed at helping those who have this condition due to either acquired (like stress incontinence) or congenital reasons.See study design
What are the potential side effects?
While specific side effects aren't listed here, treatments involving autologous tissue may include risks such as infection at the injection site, pain or discomfort during recovery, allergic reactions to materials used during treatment and potential failure to improve incontinence symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder can hold more than 100 ml of urine.
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I am between 18 and 75 years old.
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My kidney function is normal.
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I have urinary incontinence due to a weak sphincter.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6 and 12 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6 and 12 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-related serious adverse events
Secondary outcome measures
Change in Incontinence Assessment by Pad Test
Other outcome measures
Change in number of incontinence episodes and pads used per day
Trial Design
1Treatment groups
Experimental Treatment
Group I: Autologous Muscle Fiber FragmentsExperimental Treatment1 Intervention
Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region
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Who is running the clinical trial?
Wake Forest UniversityLead Sponsor
189 Previous Clinical Trials
164,570 Total Patients Enrolled
1 Trials studying Urinary Incontinence
10 Patients Enrolled for Urinary Incontinence
Gopal Badlani, MDPrincipal InvestigatorWake Forest School of Medicine, Dept. of Urology
2 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Urinary Incontinence
10 Patients Enrolled for Urinary Incontinence
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bladder can hold more than 100 ml of urine.My bladder can hold less than 100 cc of urine.I have a diagnosed bladder or kidney condition.I am between 18 and 75 years old.My kidney function is normal.I am taking medication that affects how often I urinate.I am currently using or need immunosuppressive medication.My vaginal prolapse extends outside the vaginal opening.I am not pregnant, breastfeeding, and follow strict birth control or am not sexually active.I do not have any muscle diseases or blood clotting disorders.I have a severe pelvic organ drop.I have a neurological disorder.You have a current urinary tract infection confirmed by a positive urine test.You have a different type of urinary incontinence than what is being studied.I have a history of bladder issues, including overactive or neurogenic bladder.You have a history of not being able to control your bladder.I have not had any cell therapy in the last 12 months.I have urinary incontinence due to a weak sphincter.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous Muscle Fiber Fragments
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many men and women are taking part in this experiment?
"That is accurate. The clinical trial in question, as listed on the website clinicaltrials.gov, is recruiting patients at this time. This particular study was posted on 1/1/2016 and updated on 6/6/2022; they are looking for 10 participants from a single location."
Answered by AI
Are there specific requirements to enroll in this research project?
"The prerequisites for participating in this trial are urinary incontinence and being within the age range of 18 to 75. So far, 10 individuals have been enrolled in the study."
Answered by AI
Does this research project have an age limit for participants?
"This trial is open to individuals that are between the ages of 18-75."
Answered by AI
Are people currently being signed up for this experiment?
"Based on the information available, this clinical trial is still recruiting patients. The study was originally posted on 1/1/2016 and was last edited on 6/6/2022."
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