IS-01 test

JRCT ID: jRCT1040230024

Registered date:25/05/2023

Basic Information

• Recruitment status: Not Recruiting

Health condition(s) or Problem(s) studied

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

• Date of first enrollment: 01/04/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): patients are asked to wear the IS-01 during the daytime every day during the study period (on their own penis)

Outcome(s)

• Primary Outcome: Evaluation of usability (total score of questionnaire evaluation) by "IS-01 Usage Questionnaire".

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Nohara Takahiro
• Source(s) of Monetary Support: Intron Space Inc.