N39.3
Conditions
Interventions
Group 1: Access to digital therapy Gepan® Inkontinenz-Therapie over a period of 90 days
Group 2: Waiting group with access to treatment as usual
Sponsors
G. Pohl-Boskamp GmbH & Co. KG
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Present stress urinary incontinence (SUI) diagnosed by a physician and confirmed prior to randomisation with = 1 involuntary leakage of urine on exertion / 72 h • International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) score at baseline = 5.0 • Access to smartphone / tablet (at least Android version 12, iOS version 18 and iPadOS 18) • UWritten informed consent and signed data protection declaration after having been informed about the nature, relevance and the scope of the investigation and about the expected desired and undesired effects of the MD • German residence
Exclusion criteria
Exclusion criteria: • Pregnancy • Any delivery within 6 months prior to enrolment • Non-completed regression after childbirth (no completed recovery gymnastics course if last delivery less than 12 months prior to enrolment) • Body mass index (BMI) = 40 kg/m2 • Any kind of history of pelvic surgery having led to urinary incontinencehatte • Any kind of history of surgical treatment for SUI with implantation of external material • Uncontrolled polyuria, e.g. due to diabetes mellitus type I or II, diabetes insipidus, chronic renal failure • Known urogenital descensus (degree 3-4) • Known SUI degree III or IV • Known overactive bladder and urge incontinence • Use of PFMT app other than Gepan® Inkontinenz-Therapie or face-to-face PFMT conducted by a physiotherapist at trial enrolment • Use of diuretics, ß3 agonists (e.g. mirabegron), antimuscarinics (e.g. darifenacin, hyoscyamine, oxybutynin, tolterodine, solifenacin, trospium chloride, festerodin, propiverin), desmopressin or duloxetine • Electrostimulation therapy or placed pacemaker for the bladder • Red-flag symptoms / conditions like painful urinary urgency, = 3 urinary tract infections in the past 12 months, dysuria (burning during voiding), gross haematuria, unclarified difficulty emptying the bladder, metrorrhagia (extra bleeding that occurs outside the normal menstrual cycle). • Active malignancy in the pelvic region, of the bladder or bowel • Known to be or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history) • Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in IEF over 72 hours on day 90 (IG compared to CG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean difference in ICIQ-UI-SF sum score on day 90 (IG vs. CG) Mean difference in ICIQ-LUTSqol sum score on day 90 (IG vs. CG) | — |
Countries
Germany
Contacts
Public ContactMarc Birkhahn
Gemeinschaftspraxis Urologie am Ring
Outcome results
None listed