Stress urinary incontinence related to intrinsic sphincter deficiency (ISD) is a severe form of incontinence that may have a major impact on the quality of life. The main treatment is surgical and consists in the implantation of medical devices such as the artificial urinary sphincter, adjustable continence therapy, compressive sling, or injection of bulking agent. The investigator has developed a new therapeutic strategy for ISD that consist to implant myofibers with their attached satellite cells (the main source of muscle progenitor cells) at the vicinity of the striated urethral sphincter. The principle of this method relies on the in vivo activation of satellite cells leading to the formation of regenerated myofibers (myotubes) generating a distinct and tonic muscular activity . The proof of concept was investigated in a Phase I clinical trial: Investigator found that the periurethral implantation of myofiber strips around the urethra generated an electromyographic activity improving urethral closure pressure in women with severe urinary incontinence associated to ISD. In this previous study, the technique of myofiber implantation was invasive, as it required a surgical approach and dissection of the urethra to place the myofiber. For the clinical trial IPSMA, the investigator sought to optimize the myofiber transplantation process using a method injection of myofibers core obtained by hydro-dissection. The injection technique is performed percutaneously under fluoroscopic and endoscopic control and does not require a surgical approach of the urethra. This clinical trial is prospective, open-label, non-randomized, uncontrolled, single-center for the first stage and multicenter for the second stage, of 13 months for each patient aims to assess the efficacy and safety of IPSMA in the treatment of urinary incontinence in women with ISD.
The investigator chose an assessment method in 2 stages according to the Simon plane . A total of 38 patients are needed. Assuming a ratio of 10% of lost patients or for which the primary endpoint was not evaluable, 4 additional patients will be included totaling 42 patients will be included. This trial is single-center for the first stage and multicenter for the second stage. 11 patients will be included in the first stage and 31 patients in the second stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
The first step of the procedure consists to harvest a muscle fragment from the lower part of the rectus abdominis muscle of the abdomen approached by a short incision. Injectable myofiber cores will be prepared by hydrodissection of the muscle biopsy. All myofibers cores will be suspended in autologous serum prepared by centrifugation before the incision. During the second step of the procedure, the myofibers will be injected percutaneously into the peri-sphincter region under endoscopic and radiographic control.
Henri Mondor Hospital
Créteil, France
Step 1: Tolerance
\- Tolerance: Serious adverse events grade 3 or more related to the procedure according to Data Safety and Monitoring Board (DSMB)
Time frame: One year after treatment
Step 1 and 2: Rate of patients responder at M12 after surgery
Efficiency: Response is defined by an improvement in 24h pad weight as greater than 50% reduction from baseline and improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline
Time frame: One year after treatment
Occurrence of serious and non-serious adverse events
Time frame: One year after treatment
Proportion of patients cured at M12. patients are considered as cured if: - The absence of pad use, a 24h pad test <2g AND - The absence of urinary leakage reported in the voiding diary (3 consecutive days).
Time frame: One year after treatment
Improvement of quality of life
Time frame: One year after treatment
Response times
Time frame: One year after treatment
Urodynamic evaluation
Leak Point Pressure (LPP), maximal urethral closure pressure (MUCP), area under the curve (profilometry), electromyogram (EMG) gives urodynamic evaluation
Time frame: One year after treatment
Number of re-intervention required (conventional treatment after 6 months) to treat persistent urinary incontinence after IPSMA
Time frame: 6 months after treatment
Patients with a reduction in the 24h pad test <50% at one year will be considered failure.
Time frame: One year after treatment
Direct global cost of IPSMA surgery
Time frame: One year after treatment
Healing times
Defined by : * The absence of pad use, a 24h pad test \<2g AND * The absence of urinary leakage reported in the voiding diary (3 consecutive days).
Time frame: One year after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.