None listed
Conditions
Interventions
Others(Digital Therapeutic) : Based on random assignment, the test group is prescribed a digital therapeutic, while the control group is provided with only a voiding diary without a prescription for t
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Adult males aged 19 years or older 2) Patients visiting the Department of Urology due to lower urinary tract symptoms 3) IPSS score of 13 or higher 4) Patients who are scheduled to undergo uroflowmetry and post-void residual urine measurement and are able to keep a voiding diary 5) Patients who voluntarily consent to this study
Exclusion criteria
Exclusion criteria: 1) Persons with a history of taking any of the following drugs within the past 4 weeks: ? PDE5 inhibitors ? a-blockers ? ß3 sympathomimetic agents ? Antimuscarinic/anticholinergic agents (including antimyorelaxants) ? Tricyclic antidepressants ? Synthetic vasopressins ? Loop diuretics 2) Persons with a history of taking any of the following drugs within the past 4 weeks: ? 5a-reductase inhibitors (Finasteride; however, Dutasteride is prohibited starting 24 weeks prior) ? Vesicular instillation of botulinum toxin, resiniferatoxin, capsaicin, oxybutynin, etc. 3) Persons with a confirmed PSA level of 4 or higher within the past 6 months. (However, individuals whose PSA level is confirmed to be 4 or higher and who have not been diagnosed with prostate cancer via a prostate biopsy performed within the past 6 months are eligible for selection.) 4) Patients who are unable to read or who, in the investigator's judgment, lack the capacity for independent decision-making 5) Patients who have significant difficulty using smartphones and apps 6) Patients unsuitable for clinical trials due to comorbidities such as moderate to severe cardiovascular disease, cerebrovascular disease, respiratory disease, renal disease, or liver disease 7) Uncontrolled infectious diseases 8) Uncontrolled hemorrhagic tendencies 9) Individuals undergoing chemotherapy or radiation therapy for malignant tumors 10) Other individuals deemed unsuitable for clinical trials by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS total score, OABSS total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional bladder capacity, minimal voided volume, nocturia index, Qmax, RU;Treatment and record adherence and satisfaction | — |
Countries
Korea, Republic of
Contacts
Public ContactJihee Jeong
Seoul National University Bundang Hospital
Outcome results
None listed