Periurethral Injection Of Autologous Adipose-derived Regenerative Cells For The Treatment Of Intractable Stress Urinary Incontinence: Outcome Of A Preliminary Clinical Trial | 3475
Journal of Gastrointestinal & Digestive System
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Introduction & Objective:
We have already reported a novel cell therapy technique using autologous adipose-derived regenerative cells
(ADRCs) for intractable stress urinary incontinence(SUI) and the early outcomes. To investigate the efficacy and safty of periurethral
endscopic-guided injections of autologous ADRCs in men and women with SUI caused by urethral sphincter deficiency.
Materials & Methods:
13 cases with persistent intaractble stress urinary incontinence more than 1 year after total prostatectomy(n=9),
transurethral resection of prostate(n=2) and women(n=2) were performed. After liposuction of 250 mL of adipose tissue from the
abdomen, we isolated ADRCs from this tissue using the CelutionTM system. Subsequently, the isolated ADRCs and a mixture of stem
cells and adipose tissue were transurethrally injected into the rhabdosphincter and submucosal space of the urethra, respectively.
Outcomes during a 1-year follow-up were assessed by a 24-hour pad test (mean leakage amount per day during 4 consecutive days in a
24-hour pad test), a validated patient questionnaire (ICIQ-SF), urethral pressure profile, contrast-enhanced transrectal ultrasonography,
and MRI. The present study was approved by the Ethics Committee of the Nagoya University Graduate School of Medicine and by the
Japanese Ministry of Health, Labour and Welfare, and written informed consent was obtained from the patients.
After injection, urinary incontinence progressively improved during the 1 year follow-up in all patients, i.e., decreased leakage
volume in a 24-hour pad test. The mean leakage amount per day in patient group(n=5) with moderate incontinence more than 200ml/
day and patient group(n=6) with mild incontinence less than 200ml/day decreased by 29%(from 531.1ml to 379.9ml) and 48%(from
85.6 ml to 51.9 ml ) respectively. In the urethral pressure profile, both maximum urethral closing pressure and functional profile length
increased in both patients. In all patients, ICIQ-SF demonstrated a progressive improvement in frequency and amount of incontinence
and quality of life during the 3-month follow-up. Ultrasonography and magnetic resonance imaging demonstrated sustained presence of
the injected adipose tissue. Enhanced ultrasonography revealed a progressive increase in blood flow to the injected area. No significant
adverse events were observed peri- and postoperatively.
This preliminary study demonstrated that periurethral injection of autologous ADRCs is a safe and feasible treatment
modality for patients with intractable stress urinary incontinence caused by urethral sphincter deficiency.
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