(1) Prostate cancer, after total prostatectomy (2) Stress and/or urge urinary incontinence
Conditions
Interventions
patients are asked to wear the IS-01 during the daytime every day during the study period (on their own penis)
Sponsors
Nohara Takahiro
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of usability (total score of questionnaire evaluation) by "IS-01 Usage Questionnaire". | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactTakahiro Nohara
Kanazawa University Hospital
Outcome results
None listed