Clinical trial NCT06501144: Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
Official title: Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Erectile Dysfunction
Sexual Dysfunction
Keywords: Erectile Dysfunction
Digital Health
App-based Therapy
Digital Therapeutics
Real World Evidence
Mobile Health
Behavioral Interventions
Quality of Life
Lifestyle Changes
Urology
Lead sponsor: Kranus Health GmbH
Sponsor class: INDUSTRY
Collaborators: name: Centre of Reproductive Medicine and Andrology, department of Clinical and Surgical Andrology, Münster
First posted: 2024-07-15
Enrollment: 285
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include adults with erectile dysfunction who have started the 3-month therapy with the app-based therapeutic within the last 6 months

Brief summary: The goal of this observational study is to assess the long-term effectiveness of a digital health application for treating erectile dysfunction in men aged 18 and older. The main questions it aims to answer are:

* Will participants maintain an improvement of their erectile function, that means maintain an improvement of at least 3 points in the IIEF-5 score at 3 months post-therapy?
* How does the application affect overall health status and disease-related quality of life?

Participants will:

* Complete validated questionnaires (IIEF-5, PGI-I, QOL-Med) to track erectile function, overall health status, and quality of life at up to two follow-up points after using the app with a 3-month self-management program combining cardiovascular training, pelvic floor exercises, psychological support, and educational content.
* Provide information on demographics, risk factors, and other relevant health characteristics for subgroup analysis.

Detailed description: The intervention that needs to be completed prior participation in this study involves a digital therapy program delivered via a smartphone or tablet application. This program includes several components aimed at addressing different aspects for the treatment of erectile dysfunction:

* Pelvic Floor Exercises
* Cardiovascular Exercises
* Physiotherapeutic Exercises
* Mental or sexual therapeutic Exercises
* Educational Content

Overall, the digital therapy program is designed to provide comprehensive support for men with erectile dysfuntion, addressing both physical and psychological aspects of the condition to improve symptom severity, quality of life, and patient activation.

Eligibility criteria: Inclusion Criteria:

* Men with erectile dysfunction of organic origin (ICD 10 code N48.4) and IIEF-5 score \< 21 as determined at therapy start with Kranus EDERA
* Completion of the 12-week app-based therapy with Kranus EDERA
* Improvement in the IIEF-5 score of ≥ 3 points after completion of the Kranus EDERA therapy compared to the score at the start of the therapy
* Age over 18

Exclusion Criteria:

* Failure to provide informed consent
* Started a new therapy with Kranus EDERA between the end of the last therapy cycle and patient survey
* Started PDE-5 inhibitor treatment during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Underwent prostatectomy (removal of the prostate gland), radiation or seeds of the prostate gland during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Performed auto-injection therapy (SKAT, MUSE) during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Obtained a penile implant during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Underwent major surgery in the small pelvis with probable impairment of the neurovascular supply (e.g., rectum resection, urinary bladder removal) during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Nervous diseases (e.g., multiple sclerosis (MS), Parkinson's disease, stroke, dementia, psychiatric diseases) acquired during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Developed pronounced circulatory disorders (peripheral arterial occlusive disease) during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Trauma involving the pelvis/penis/spine during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
* Any other newly developed diseases potentially affecting erectile function (e.g., leading to a longer period of hospitalization) during the Kranus EDERA therapy or between the end of the therapy cycle and patient survey

Primary outcomes:
measure: Assessment of the real-world longitudinal effect of the intervention
timeFrame: 6 months after start of the app-based therapy
Secondary outcomes:
measure: Assessment of the real-world effect of the intervention on overall improvement of patients' health status
timeFrame: 6 months after start of the app-based therapy
measure: Assessment of the real-world effect of the intervention on disease-related quality of life
timeFrame: 6 months after start of the app-based therapy
Other outcomes:
measure: Other outcome measures/variables
timeFrame: 6 months after start of the app-based therapy
Locations:
city: Münster
country: Germany
facility: CeRa Münster, Centre of Reproductive Medicine and Andrology
Study officials:
affiliation: CeRA Münster, Centre of Reproductive Medicine and Andrology , department of Clinical and Surgical Andrology, Münster, Germany
name: Sabine Kliesch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiemer L, Bartelheimer T, Raschke R, Miller K. [First data from a digital health app for erectile dysfunction]. Urologie. 2022 Sep;61(9):971-981. doi: 10.1007/s00120-022-01872-x. Epub 2022 Jun 20. German.
citation: Kliesch S, Cremers JF, Krallmann C, Epplen R, Scheffer B, Schubert T, Schubert M, Dreger NM, Raschke R, Khaljani E, Maxeiner A, Miller K, Wiemer L, Zitzmann M. App-based Therapy of Erectile Dysfunction Using a Digital Health Application (EDDIG Study): A Randomized, Single-blind, Controlled Trial. Eur Urol Focus. 2024 Dec;10(6):1003-1010. doi: 10.1016/j.euf.2024.05.020. Epub 2024 Jun 8.