Pelvic floor dysfunction following oncological treatment (urinary incontinence, fecal incontinence, LARS, pelvic floor weakness). Diagnoses: Prostate cancer, gynecological cancers, colorectal/rectal cancers.
Conditions
Interventions
Group 1: Participants complete an 8-week home-based training program using the n Apelvo training-system. At the baseline visit (t0), participants first complete the visual analogue scales (VAS) for su
Sponsors
AG Versorgungsforschung | Pflege im Krankenhaus Department für Innere Medizin | Universitätsmedizin Halle (Saale)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Medically stable condition suitable for independent home-based training • Cognitive ability to independently operate a mobile application • Possession of a mobile device (Android/iOS) • Confirmed oncological diagnosis involving the pelvic region: • Prostate carcinoma (following radical prostatectomy), or • Gynecological carcinoma (following surgical or radiation treatment), or • Colorectal/rectal carcinoma (following resection, with or without stoma) Indication for pelvic floor training (at least one of the following): • Self-reported urinary or fecal incontinence (mild to severe), or • Low Anterior Resection Syndrome (LARS score =21), or • Pelvic floor weakness without overt incontinence, or • Preventive indication in stoma patients (preparation for stoma reversal) Minimum time interval since primary treatment: • At least 4 weeks following prostatectomy AND removal of the urinary catheter • At least 6 weeks following gynecological surgery • At least 6 weeks following colorectal resection/stoma creation • At least 6 weeks following stoma reversal • At least 4 weeks following completion of radiation therapy
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: • Acute postoperative phase • Unresolved wound infections or postoperative complications • Severe pain in the pelvic or perianal region (VAS > 6/10) • Acute bleeding or pronounced bleeding tendency • Cognitive impairments preventing independent training • Severe neurological disorders involving complete denervation of the pelvic floor musculature • Ongoing radiotherapy (active radiation treatment) • Severe cardiovascular instability (NYHA Class IV, unstable angina pectoris) • Acute urinary tract infections (until resolution) • Skin conditions at the electrode placement site in the coccygeal region (eczema, open wounds, psoriasis) Diagnosis-specific exclusion criteria: For prostate carcinoma: • Anastomotic insufficiency (incomplete healing of the bladder-urethral junction) For gynecologicalpPatients: • Recent mesh implantation (< 8 weeks) • Current pregnancy For gastroenterological oncology patients: • Anastomotic insufficiency or leakage (following any surgery involving an anastomosis) • Acute stoma complications (prolapse, retraction, necrosis, parastomal hernia) • Active perianal/perineal wound healing disturbances • Rectovaginal, rectourethral, ??or enterocutaneous fistulas • Acute peritonitis or intra-abdominal abscesses • Anastomotic stenosis with significant obstruction (until intervention)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| User Acceptance of the Apelvo Pelvic Floor Training System Following Completion of the 8-Week Training Phase (T1), Assessed via the System Usability Scale and Semi-Structured Interview | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint 1: Training Adherence; the proportion of completed training sessions relative to recommended sessions (training frequency, training volume in minutes, training points), recorded weekly throughout the 8-week training phase (T0–T1) in a training diary. Secondary Endpoint 2: Dropout Rate; the proportion of participants who withdraw from the study prematurely (T0–T1). Secondary Endpoint 3: Subjective Perception of Pelvic Floor Function, assessed prior to the provision of the Apelvo system (T0) and after 8 weeks (T1) using a VAS scale. Secondary Endpoint 4: Qualitative Acceptance Parameters (experiences with biofeedback, gamification, motivation, perceived strengths/weaknesses, suggestions for improvement), assessed following the completion of the training phase (T1) via a semi-structured interview (recollection protocol). | — |
Countries
Germany
Contacts
Public ContactAnna Heinrich
AG Versorgungsforschung | Pflege im Krankenhaus Department für Innere Medizin | Universitätsmedizin Halle (Saale)
Outcome results
None listed