A Phase 1/2 interventional study of Autologous Muscle Fiber Fragments in Urinary Incontinence, sponsored by Wake Forest University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Wake Forest University · Phase 1/2, Interventional, and Treatment
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).
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 10 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Wake Forest University is the lead sponsor of 118 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region
Other: Autologous Muscle Fiber Fragments
Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region
Incidence of treatment-related serious adverse events
the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization
Time frame: 12 months
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
Time frame: baseline, 3, 6, and 12 months post-treatment
Change in number of incontinence episodes and pads used per day
voiding diaries and pads used each day will be compared to baseline
Time frame: baseline, 3, 6 and 12 months post-treatment
Plan to share: No
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