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

JRCT ID: jRCTs052210157

Registered date:21/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stress urinary continence after radical prostatectomy
• Date of first enrollment: 07/11/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Pilot study of transurethral Deflux infusion therapy for male stress urinary incontinence after radical prostatectomy

Outcome(s)

• Primary Outcome: The occurrence of an adverse event or device failure
• Secondary Outcome: Improvement of incontinence and QOL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ukimura Osamu