N40 N32.8
Conditions
Interventions
Group 1: The intervention group receives access to the 'male LUTS digital therapy' in addition to care-as-usual.
Group 2: The control group receives care-as-usual. Patients will also get accesss to th
Sponsors
APOGEPHA Arzneimittel GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects with confirmed bothersome LUTS (ICD10: N40, N32.8), who meet at least • IPSS = 4 OR • ICIQ-OAB = 3 • and have had symptoms for at least three months 2. Treatment-naïve subjects OR subjects receiving stable pharmacological treatment for included indications for at least = 12 weeks before inclusion visit 3. Participants who are able to understand, read and write German 4. Subjects who are physically able to carry out exercises 5. In possession of a smartphone with internet access and willing and able to use it for study purpose 6. Willing to participate and capable of providing informed consent
Exclusion criteria
Exclusion criteria: 1. Surgical intervention of the lower urinary tract during the 12 months prior to study inclusion (including botulinum toxin injections) 2. Other surgical interventions which, at the investigator's discretion, may have an influence on micturition behaviour. 3. Recurrent macroscopic haematuria 4. Acute or recurrent urinary tract infections (2 UTIs in the last 6 months or = 3 UTIs in the last 12 months) 5. Recurrent urinary retention 6. Bladder stones 7. Cancer of the bladder or pelvic area 8. Neurological diseases (e.g., neurogenic bladder, MS, SCI) 9. Intermittent or indwelling catheterisation 10. Severe heart insufficiency (> NYHA II), severe kidney insufficiency (eGFR < 45 ml/min) 11. Patients with residual excretion in terminal renal failure and hemodialysis 12. Severe psychiatric disorder possibly resulting in noncompliance (as judged by the investigator) 13. Uncontrolled diabetes mellitus 14. Medication which, at the discretion of the investigator, do not allow for a participation in the study 15. Use of other pelvic floor muscle training or bladder training app within the last three months prior to inclusion or during the clinical study 16. Subjects who participated in another clinical study within the last three months prior to inclusion or during the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the IPSS at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in ICIQ-OAB at week 12 Change from baseline in mean number of micturitions/24 h at week 12 Change from baseline in mean number of urgency episodes/24 h at week 12 Change from baseline in nocturia at week 12 Change from baseline in number of incontinence episodes/24 h at week 12 Change from baseline in voided volume at week 12 Change from baseline in IPSS-QoL at week 12 PGI-I at week 12 | — |
Countries
Germany
Outcome results
None listed