Japan’s MHLW approves patient enrollment in ADRESU trial for stress urinary incontinence

The one-year open-label, multi-center, single arm ADRESU trial is designed to evaluate the efficacy and safety of periurethral injection of autologous adipose derived regenerative cells for the treatment of male stress urinary incontinence following prostatectomy for prostate cancer.

The investigator-initiated trial is aimed at securing product approval for Cytori Cell Therapy technology for this indication.

Nagoya University Graduate School of Medicine Department of Urology chairman Momokazu Gotoh and Department of Urology associate professor Tokunori Yamamoto will be responsible for leading the trial, which is primarily sponsored and funded by the Japanese Government.

Around 45 patients will be enrolled in this trial at four centers within Japan.

Primary endpoint of the trial will be to evaluate the improvement in urine leakage volume from baseline by 24-hour pad test.

The trial’s key secondary endpoints include: urine leakage volume at each evaluation time point by 24-hour pad test, improvement in the number of incontinence episodes per day with greater than 50% reduction from baseline, number of incontinence episodes per day, number of pads used per day, key quality of life scores.

Patient overall satisfactions, key urodynamic parameters, blood flow at the injection site measured by transrectal ultrasonography and evaluation of the injection site by pelvic MRI scan are also included in the secondary endpoints.