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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Autologous Muscle Fiber Fragments
Other interventionAutologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Autologous Muscle Fiber FragmentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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-treatmentOther outcomes
1
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-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov