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Evaluation of the IS-01, a new device for urinary care in male patients with urinary incontinence. (IS-01)

IS-01 test

10

Stress urinary incontinence (more than 1 pad/day) after radical prostatectomy

Of the 17 patients identified as eligible, 12 were informed about the clinical trial. 2 refused to participate, but 10 were willing to participate. Of the 10, 4 discontinued the study during the observation period. The questionaire analyzed the remaining 6 patients.

Six of the 10 patients had adverse events: spontaneous dislodgement of the device occurred in four patients, two of whom discontinued the study; one patient discontinued the study due to penile pain caused by the tightness of the device. The remaining one patient's urinary incontinence improved with the postoperative course and the study was discontinued midway through the observation period.

In the King Health Questionnaire assessment of incontinence severity, the mean incontinence severity score of the six patients significantly improved from 47.8 to 16.7 points, indicating improved quality of life in urinary incontinence. For the secondary endpoint, ICIQ-SF question 3, the mean score improved from 5.8 to 4.8 points, but this was insignificant.

Patients who were able to continue using the product showed improved quality of life, suggesting that it may be a useful device to support a comfortable life for male patients with urinary incontinence. Future product improvement is desirable, as it is difficult to use if the size of the penis is not suitable for use.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1040230024

Nohara Takahiro

Kanazawa University Hospital

13-1, Takara-machi, Kanazawa-city, Ishikawa

t_nohara704@yahoo.co.jp

Nohara Takahiro

Kanazawa University Hospital

13-1, Takara-machi, Kanazawa-city, Ishikawa

+81-762652393

urology@med.kanazawa-u.ac.jp

Complete

April. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

health services research

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.

(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

Male

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

patients are asked to wear the IS-01 during the daytime every day during the study period (on their own penis)

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

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)

+81-76-265-2048

Mar. 31, 2023

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