C61
Conditions
Interventions
Group 1: Intervention group - Uroletics App + standard of care according to the German S3 guideline “Prostatakarzinom”
Group 2: Control group - standard of care according to the German S3 guideline “P
Sponsors
Rocketlane Medical Ventures GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Medically confirmed diagnosis prostate cancer (ICD10: C 61). - Subjects scheduled to undergo RP for treatment of prostate cancer within 21 to 56 days after inclusion. - RP planned to be performed in a nerve sparing manner (unilateral or bilateral). - Eastern Cooperative Oncology Group (ECOG) status 0 or 1. - Subjects who have access to a mobile device and are skilled in the use of it and who have access to the internet and who are willing to use the mobile device within the study. - Subjects who are able to fill in questionnaires. - Subjects who are able to understand, read and write in German language. - Provide written informed consent.
Exclusion criteria
Exclusion criteria: - At inclusion, clinical or radiological evidence of extraorgan extension of the prostate tumour. - Prostate volume >80 ml. - Neoadjuvant therapy of prostate carcinoma. - Other active carcinoma within 1 year of inclusion in the study. - Self-catheterization within 1 year of inclusion in the study. - Chronic urinary tract infection (>5 treatment cycles with antibiotics within 1 year of inclusion in the study). - Underlying neurological disease (e.g., multiple sclerosis, morbus parkinson, polyneuropathy). - Immunosuppression (equivalence dose of prednisolone >100mg). - Performance of dialysis. - Use of a PFMT app. - Simultaneous participation in another clinical study. - Self-report of urinary incontinence within the last 6 months prior to study inclusion. - Body mass index > 35. - Severe cognitive dysfunction. - Severe visual and hearing impairment impacting the use of the app. - Surgeries or treatments =3 months before inclusion in the study which in the opinion of the investigator may influence the study participation or outcome (e.g., surgery of sigma, advanced hemorrhoidectomy, transurethral needle ablation, osteosynthesis of the pelvis). - Severe concomitant diseases which in the opinion of the investigator may influence the study participation or outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to continence (maximum observation period: 12 weeks after removal of urinary catheter) | — |
Secondary
| Measure | Time frame |
|---|---|
| - 4, 8 and 12 weeks after removal of urinary catheter: 1. Continence rate 2. Severity of incontinence 3. Erectile function 4. Distress 5. Quality of life - 12 weeks after removal of urinary catheter: 6. Change in symptoms | — |
Countries
Germany
Outcome results
None listed