Erectile DysfunctionRELOEDNCT06501144
Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
An observational study of Erectile Dysfunction and Sexual Dysfunction, run by Kranus Health GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Sexual Dysfunction
- How many people
- 317 participants
- Where
- 1 siteGermany
- Study dates
- 8 Aug 2024to 8 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
CeRa Münster, Centre of Reproductive Medicine and Andrology
Münster, Germany, 48149
About this study
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?
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the real-world longitudinal effect of the intervention
The primary endpoint is the rate of patients maintaining an IIEF-5 score improvement of ≥ 3 points compared to baseline (start of app-based therapy) after the app-based therapy
Measured: 6 months after start of the app-based therapy
Secondary outcomes (2)
Assessment of the real-world effect of the intervention on overall improvement of patients' health status
Assessment of overall improvement of patients' health status using the PGI-I questionnaire
Measured: 6 months after start of the app-based therapy
Assessment of the real-world effect of the intervention on disease-related quality of life
Assessment of disease-related quality of life using the QOL-Med questionnaire
Measured: 6 months after start of the app-based therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start8 Aug 2024
- Primary completion5 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kranus Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre of Reproductive Medicine and Andrology, department of Clinical and Surgical Andrology, Münster
- Responsible party
- Sponsor
- Investigators
- Sabine Kliesch, MD, Principal investigator, CeRA Münster, Centre of Reproductive Medicine and Andrology , department of Clinical and Surgical Andrology, Münster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501144
- Sponsor's protocol ID
- RELOED01
- Acronym
- RELOED
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35925101Kliesch 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.
PubMed 38853028
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06501144
- Acronym / sponsor ID
- RELOED / RELOED01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Kranus Health GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Centre of Reproductive Medicine and Andrology, department of Clinical and Surgical Andrology, Münster
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the real-world longitudinal effect of the intervention
Time frame: 6 months after start of the app-based therapy
The primary endpoint is the rate of patients maintaining an IIEF-5 score improvement of ≥ 3 points compared to baseline (start of app-based therapy) after the app-based therapy
2 secondary outcomes
Assessment of the real-world effect of the intervention on overall improvement of patients' health status
Time frame: 6 months after start of the app-based therapy
Assessment of the real-world effect of the intervention on disease-related quality of life
Time frame: 6 months after start of the app-based therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 35925101Wiemer 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.
- Background: PubMed 38853028Kliesch 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Kliesch, MD principal investigator
CeRA Münster, Centre of Reproductive Medicine and Andrology , department of Clinical and Surgical Andrology, Münster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction and Sexual Dysfunction, run by Kranus Health GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the real-world longitudinal effect of the intervention (time frame: 6 months after start of the app-based therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06501144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.