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

Phase 2

Recruiting

• Conditions: Stress urinary continence after radical prostatectomy; Stress urinary incontinence, post prostatectomy; D014549

• Registration Number: JPRN-jRCTs052210157
• Lead Sponsor: kimura Osamu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 5

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of an adverse event or device failure

Secondary Outcome Measures

Name	Time	Method
Improvement of incontinence and QO