Muscle Fiber Fragment Treatment for Urinary Incontinence
ConditionUrinary Incontinence
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWake Forest University
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Autologous Muscle Fiber Fragments
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov