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Systematic data evaluation to determine positive care effects for the medical device FEMANEA in patients with conservatively treated urinary incontinence

Systematic data evaluation to determine positive care effects for the medical device FEMANEA in patients with conservatively treated urinary incontinence - digiFEMICAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034031
Enrollment
74
Registered
2024-04-19
Start date
2024-05-03
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N39.3 N39.47 N39.48

Interventions

Group 1: In addition to the reality of care, the patients in the intervention group receive an access code for the DiGA FEMANEA, which contains a 90-day personalized exercise therapy with evidence-bas

Sponsors

PrehApp GmbH
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of pure stress incontinence (ICD-10 code: N39.3) (severity levels 1 and 2 according to Ingelman-Sundberg) or mixed urinary incontinence with leading stress symptoms (according to the ICD-10 codes: N39.47, N39.48). previously carried out sonography with residual urine determination and vaginal adjustment by urologists and gynecologists with completed specialist training or assistant doctors in the fields of urology and gynecology under specialist supervision Ability of the participant to understand the nature and scope of the data collection and the training program Fulfillment of the technical requirements Presence of a written declaration of consent for data collection

Exclusion criteria

Exclusion criteria: Pure urge incontinence (N39.42) or mixed urinary incontinence with leading urge symptoms, overflow incontinence (N39.41) and extraurethral urinary incontinence (N39.43) Stress incontinence (N39.3) > Grade 2 and/or prolapse of the genital organs that is not treated with pessary therapy > Grade 2 Previous urinary incontinence surgery or surgical correction of urinary incontinence (within one year)/more than one surgical procedure for urinary incontinence Hematuria or a history of more than three urinary tract infections in the past year Congenital defects or abnormalities associated with incontinence Existing bladder or rectal fistulas Gynecological or urological tumor diseases currently being treated with chemotherapy or radiotherapy Interstitial cystitis (N30.1) or chronic pelvic pain Current symptomatic pelvic floor prolapse Patients scheduled to undergo surgery within 90 days of admission Patients including the first six weeks after birth or in the postpartum period Use of a comparable app at the same time or planned within the next 90 days or participation in a competing intervention study Insufficient reading ability or lack of understanding of the German language Mental or physical limitations that prevent you from correctly understanding the contents of the app or performing the exercises correctly Restrictions in perception, e.g. due to medication or injuries (in particular vision, hearing, balance), unless the restrictions are compensated for by an appropriate aid (e.g. glasses). Disease of the cardiovascular system in which exercise is contraindicated Acute infection, e.g. with fever/chills pregnancy

Design outcomes

Primary

MeasureTime frame
- Subjectively perceived severity of impairment measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) - Health-related quality of life measured using the King's Health Questionnaire (KHQ)

Secondary

MeasureTime frame
- Quantification of the frequency of involuntary urine loss over the last 3 days using a toilet/drinking protocol - Quantification of the amount of involuntary urine loss in the last 24 hours using a 24-hour pad test - Active patient participation measured using PAM-13

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026