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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052210157

Registered date:21/01/2022

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedStress urinary continence after radical prostatectomy
Date of first enrollment21/01/2022
Target sample size5
Countries of recruitment
Study typeInterventional
Intervention(s)Pilot study of transurethral Deflux infusion therapy for male stress urinary incontinence after radical prostatectomy

Outcome(s)

Primary OutcomeThe occurrence of an adverse event or device failure
Secondary OutcomeImprovement of incontinence and QOL

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderMale
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Osamu Ukimura
Address 465 Kaji-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-856 6, Japan Kyoto Japan 602-8566
Telephone +81-75-251-5595
E-mail ukimura@koto.kpu-m.ac.jp
Affiliation University Hospital, Kyoto Prefectural University of Medicine
Scientific contact
Name Osamu Ukimura
Address 465 Kaji-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-856 6, Japan Kyoto Japan 602-8566
Telephone +81-75-251-5595
E-mail ukimura@koto.kpu-m.ac.jp
Affiliation University Hospital, Kyoto Prefectural University of Medicine