Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: A phase i clinical trial

摘要

Objectives To assess the safety of periurethral myofibre implantation in patients with urinary incontinence due to intrinsic sphincter deficiency (ISD) To assess the resulting myogenic process and effects on urinary continence. Patients and Methods An open-label non-randomised phase I clinical trial was conducted in five men and five women with ISD (mean age, 62.5 years). A free muscle strip from the patient's gracilis muscle was implanted around the urethra as a means to deliver locally myofibres and muscle precursor cells (MPCs). Patients were assessed for collection formation and incomplete bladder emptying. The maximum urethral closure pressure (MUCP) and concomitant periurethral electromyographic (EMG) activity were recorded before surgery and 1 and 3 months after surgery. Continence was assessed using the 24-h pad test and self-completed questionnaires, for 12 months. Results There were no serious side-effects. Continence improved significantly during the 12-month follow-up in four of the five women, including two who recovered normal continence. In the women, MUCP increased two-fold and de novo EMG periurethral activity was recorded. In the men, MUCP and EMG recordings showed similar improvements but the effect on continence was moderate. The few patients enrolled could affect these results. Conclusions This is the first report of a one-step procedure for transferring autologous MPCs via myofibre implantation in patients with ISD. EMG and urodynamic assessments showed improvement of periurethral muscle activity. Further work is needed to confirm and improve the therapeutic efficiency of this procedure.