Regenerative treatment for male stress urinary incontinence by periurethral injection of adipose-derived regenerative cells: Outcome of the ADRESU study.

To report the outcome of the ADRESU study, a multicenter, single-arm, investigator-initiated clinical trial to confirm the efficacy and safety of regenerative treatment for male patients with stress urinary incontinence.

The participants were male patients with mild-to-moderate stress urinary incontinence persisting for >1 year after prostatectomy. Autologous adipose-derived regenerative cells were isolated using the Celution system from adipose tissue obtained by liposuction. Adipose-derived regenerative cells and mixture of adipose-derived regenerative cells with adipose tissue were transurethrally injected into the rhabdosphincter and submucosal space of the urethra, respectively. The primary end-point was the proportion of patients with improvement of the urine leakage volume at 52 weeks (or last visit within 52 weeks). Improvement of leakage volume was defined as a decrease from baseline >50% by the 24-h pad test. A total of 10 secondary end-points were set.

A total of 45 patients satisfying the eligibility criteria were enrolled. The primary end-point was met; the proportion of patients with improvement in leakage volume at 52 weeks was 37.2% (95% confidence interval 23.0-53.3%). No serious adverse events with causal relationships to the adipose-derived regenerative cells were encountered. There was a progressive improvement in secondary end-points. In the King's Health Questionnaire, improvement of quality of life scores showed greater improvement in responders, as compared with non-responders.

Findings from the ADRESU study suggest the efficacy and safety of regenerative treatment for male patients with mild-to-moderate stress urinary incontinence.

International journal of urology : official journal of the Japanese Urological Association. 2020 Jul 30 [Epub ahead of print]

Momokazu Gotoh, Shinobu Shimizu, Tokunori Yamamoto, Osamu Ishizuka, Tomonori Yamanishi, Atsushi Mizokami, Kazutaka Narimoto, Kazuhiro Toriyama, Yuzuru Kamei, Shinobu Nakayama, Yachiyo Kuwatsuka, Masaaki Mizuno, Akihiro Hirakawa

Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan., Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan., Department of Urology, Shinshu University School of Medicine, Matsumoto, Nagano, Japan., Department of Urology, Continence Center, Dokkyo Medical University, Shimotsuga, Tochigi, Japan., Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan., Department of Plastic Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Aichi, Japan., Department of Plastic and Reconstructive Surgery, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan., Department of Clinical Research Management, Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan., Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

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