C61 N39.3
Conditions
Interventions
Group 1: The presented study is a multi-center investigation to evaluate the effectiveness of a new treatment concept. With regard to the potential effect size resulting from perioperative, modular, a
Sponsors
AKH ViersenKlinik für Urologie
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Only the following patients will be included in the observational study: - all patients who consent to data collection - all patients who have signed the informed consent form - all patients who are legally competent and mentally able to complete the questionnaires - locally-confined prostate cancer - Planned robotic-assisted, laparoscopic, or open surgery radical prostatectomy - Distance of residence to study center =60 km.
Exclusion criteria
Exclusion criteria: Because this is an observation of routine clinical practice, no patients meeting the inclusion criteria will be excluded. - Lack of capacity for insight and consent (e.g., caregiver relationship, written/language barriers). - Lack of manual or technical requirements for smartphone use e.g. lack of availability of Android-based smartphone. - Patient lives >60km away from the study center (realization of follow-up appointment more difficult). - Withdrawal of study consent by patient. - ASA (American Society of Anesthesiology) classification > 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the planned study is to evaluate the impact of perioperative, modular and audiovisual pelvic floor training compared to standard care on the endpoints of urinary incontinence and quality of life at defined time points. Urinary continence at defined time points: Days 21, 1, 6, 30 and 90 are defined as preoperative days and days 6, 30 and 90 as postoperative days. Urinary continence-related quality of life at defined time points (days 21, 1, 6, 30 and 90). Voiding-related quality of life at defined time points (days 21, 1, 6, 30 and 90). Long-term functional outcomes of modular, app-based, perioperative pelvic floor training (days 180, 360 and 540). The subgroup analysis will examine the feasibility of modular, audiovisual, perioperative pelvic floor training in patients in the RP setting. Can patients be motivated to participate? Do patients in the relevant age group have Android-based smartphones with the Pelvintense app? | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluation of patient satisfaction with the biofeedback mechanism in the intervention group at defined time points (d -1, d 30, d 90). - Evaluation of patient satisfaction with the visually guided BBT in the intervention group at defined time points (d -1, d 30, d 90). - Evaluation of patient satisfaction with the technical robustness of the app (Pelvintense) during the study period at defined time points (d -1, d 30, d 90). - Recording of side effects caused by the BBT ("muscle soreness") in the intervention group and also in the control group at defined time points (d -1, d 30, d 90). - Recording of the training intensity performed during the study period in the intervention group (based on the records of the app (Pelvintense), read at time point d 90). | — |
Countries
Germany
Contacts
Public ContactChristian Rehme
Uni-Klinik EssenKlinik für Urologie
Outcome results
None listed