Between January 2019 and December 2021, we performed a prospective trial that enrolled male patients with SUI post RP. A total of 10 patients were randomized into 1 of 2 groups: treatment group (received a single injection into the urethral rhabdosphincter 10ml of ADSC solution), or placebo group (single injection into the urethral rhabdosphincter of 10ml of normal saline). ADSCs were injected using a template showing 8 injections (1.25 ml/injection) throughout the rhabdosphincter, at 12,6,3,9,2,10,5, and 7 o’clock positions. Injections were delivered at a depth of 5 mm with a rigid scope under general anesthesia using a bladder injection needle 22Gauge (tip length 4mm, working length 35cm). ADSCs solution was reconstituted in 5 ml of sterile saline. Liposuction was performed from the treatment group to isolate ADSCs. Briefly, the lipoaspirate was digested with collagenase, at 37 °C. Then it was washed 3 times with cold phosphate-buffered saline (PBS). The Stromal vascular fraction was plated into a culture flask. The medium was replaced every 3 days and cultured in expansion. The cells are used after confluence in the first passage.
Inclusion criteria were: patients with an SUI for > 18 months after surgery, localized low to intermediate-risk prostate cancer before surgery, have no biochemical recurrence at study enrollment, the patient had no adjuvant chemotherapy or radiotherapy, all patients had pelvic floor training for > 6 months. All patients had office cystoscopy before entering the study to exclude bladder neck contracture or urethral stenosis.
Exclusion criteria were: patients taking anticholinergic medications for overactive bladder symptoms or taking a diuretic for heart failure, patients with urinary tract infection, patients with any neurologic disease that may affect bladder function.
Eligible participants were randomly assigned to one of the 2 groups by a computer-generated lottery. Both the urologists and the patients were blinded to the treatment assignments.
The amount of incontinence was evaluated with a 24-h pad weight test. This test was noted in each evaluation period ( baseline, 1, 3, 6, 12, and 18 months). Patients were allowed to use as many pads as they deemed necessary and were provided sealable bags labeled day 1, 2, and 3. They were asked to store their pads in the provided sealed bag in the refrigerator to minimize evaporation. The patient brings all pads to each clinical visit. Each soiled pad was weighed using a calibrated scale. The mean of 24-hour pad weight noted during the 3 days in each patient was calculated at baseline and during each clinical visit. Quality-of-life survey (International Consultation on Incontinence Questionnaire- Short Form (ICIQ-UI SF) was collected before therapy and during the follow-up visit.
Incontinence has been categorized into three categories based on the gram (g) weight of urinary loss–mild SUI, or <100g/24 hours, moderate SUI, or 100–400g/24 hours, and high-grade, or >400g/24 hours to help classify the degree of incontinence [3].
The primary outcomes of our study were the change from baseline in the mean of the 24-h pad weight test. The secondary outcomes were the change from baseline in the mean of ICIQ-UI SF score. Safety assessments included any reported adverse events.
The study was approved by our Institutional Review Board (N.05/2019). This trial was registered in the UMIN clinical trial registry (UMIN000047336). Written informed consent was taken by all the patients to participate in the study.