Regenerative treatment for male stress urinary incontinence by periurethral injection of adipose-derived regenerative cells: Outcome of the ADRESU study.
adipose-derived regenerative cells
cell therapy
investigator-initiated clinical trial
prostatectomy
stress urinary incontinence
Journal
International journal of urology : official journal of the Japanese Urological Association
ISSN: 1442-2042
Titre abrégé: Int J Urol
Pays: Australia
ID NLM: 9440237
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
30
04
2020
accepted:
09
06
2020
pubmed:
31
7
2020
medline:
28
4
2021
entrez:
31
7
2020
Statut:
ppublish
Résumé
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.
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
859-865Subventions
Organisme : Japan Agency for Medical Research and Development
ID : JP18bk0104057
Pays : International
Informations de copyright
© 2020 The Japanese Urological Association.
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