IS-01 test

Phase 1

• Conditions: (1) Prostate cancer, after total prostatectomy(2) Stress and/or urge urinary incontinence

• Registration Number: JPRN-jRCT1040230024
• Lead Sponsor: ohara Takahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

1) Patients who are expected to have persistent urine leakage after robot-assisted total prostatectomy at Kanazawa University Hospital
(2) Patients attending the outpatient clinic of the Department of Urology at Kanazawa University Hospital who have been using urine pads or diapers at least 1 piece/day for at least 6 months.

Exclusion Criteria

(1) Patients who cannot give written informed consent for this study
(2) Patients who cannot wear the IS-01 by themselves due to medical reasons such as paralysis of the upper limbs or cognitive impairment
(3) Patients who are considered unfit to use the IS-01 for medical reasons such as severe skin diseases
(4) Patients who have difficulty completing the questionnaire
(5) Other patients deemed inappropriate as research subjects by the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of usability (total score of questionnaire evaluation) by IS-01 Usage Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Arm1: Change in ICIQ-SF over time (2, 4, and 12 weeks), respectively<br>Comparison of the number of pads used daily <br>Arm2: Change in ICIQ-SF over time (2, 4, and 12 weeks) <br>Number of pads used daily (compared to pre-registration)