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Pilot study of transurethral Deflux infusion therapy for male stress urinary incontinence after radical prostatectomy

Pilot study of transurethral Deflux infusion therapy for male stress urinary incontinence after radical prostatectomy - ArtPro1

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052210157
Enrollment
7
Registered
2022-01-21
Start date
2023-11-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress urinary continence after radical prostatectomy Stress urinary incontinence, post prostatectomy

Interventions

Pilot study of transurethral Deflux infusion therapy for male stress urinary incontinence after radical prostatectomy
transurethral Deflux infusion therapy

Sponsors

Ukimura Osamu
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients with persistent stress urinary incontinence for more than 1 year and 6 months at the time of consent, despite conservative treatment including drug treatment after radical prostatectomy 2)Patients with urinary incontinence of 10g or more and 500 g or less in the 24-hour pad test of the pre-registration test 3)Patients who can obtain written consent to participate in the study at their own will 4)Patients aged 20 years or older at the time of consent acquisition 5) male

Exclusion criteria

Exclusion criteria: 1) Patients with urinary tract infection 2) Patients with a history of radiation therapy to the prostate 3) Patients with residual urine >100ml 4) Patients with artificial sphincter implantation 5) Patients with PSA >0.2 ng/ml 6) Patients contraindicated in the package insert of Deflux 7) Other patients who are judged to be ineligible by the principal investigator

Design outcomes

Primary

MeasureTime frame
The occurrence of an adverse event or device failure

Secondary

MeasureTime frame
Improvement of incontinence and QOL

Contacts

Public ContactOsamu Ukimura

University Hospital, Kyoto Prefectural University of Medicine

ukimura@koto.kpu-m.ac.jp+81-75-251-5595

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026