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

Not Applicable

Recruiting

• Conditions: N39.3; N39.47; N39.48; Stress incontinence

• Registration Number: DRKS00034031
• Lead Sponsor: PrehApp GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 74

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Subjectively perceived severity of impairment measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)<br>- Health-related quality of life measured using the King's Health Questionnaire (KHQ)

Secondary Outcome Measures

Name	Time	Method
- Quantification of the frequency of involuntary urine loss over the last 3 days using a toilet/drinking protocol<br>- Quantification of the amount of involuntary urine loss in the last 24 hours using a 24-hour pad test<br>- Active patient participation measured using PAM-13