F52.4
Conditions
Interventions
Group 1: Group B will receive access to the Melonga app for 12 weeks at t=0.
Group 2: Group A serves as a control group for 12 weeks and then receives the app between weeks 13 and 24
Sponsors
Prognoix Health BV
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) PEDT score > 9 2) male, at least 18 years old 3) Sexually active with a partner at the time of recruitment (both temporary and permanent partners are acceptable) 4) Owns a smartphone and is familiar with iOS or Android smartphones. 5) Generally good health (both physical and mental), which will be documented in the anamnesis interview with the investigator. 6) Can speak and read German or English very well 7) Available for the duration of the study 8) Willingness to wait possibly 3 months before starting the intervention 9) Submission of a dated and signed informed consent form
Exclusion criteria
Exclusion criteria: 1) Previous treatment with another preparation or intervention for EP within the last three months 2) Presence of sexual dysfunction other than EP (specifically erectile dysfunction with a current IIEF-5 < 22) . 3) Initiated treatment of sexual dysfunction other than EP in the last 4 weeks or intending to do so in the next 6 months. 4) History of symptoms of prostatitis or active inflammation in the urogenital area. 5) Psychiatric diseases requiring treatment with antidepressants from the SSRI group. 6) Physical function or mental impairment that prevents the participant from performing or understanding the required tasks of the study or completing the questionnaires. 7) Rejection of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement (increase) in PEP score by at least 2 points compared to a control group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General sexual function (measured with the IIEF-15 questionnaire) 2. Sexual quality of life (measured with the SQoL-M questionnaire) 3. Patient activation (measured by the PAM-13 questionnaire) 4. Improving access to medical care through digital tools (measured by the Acceptability E-scale) 5. Self-reported IELT (Intravaginal Ejaculation Latency) + two self-formulated questions on the patient reported outcome (PRO) 6. PHQ-4 questionnaire 7. PEDT questionnaire | — |
Countries
Germany
Contacts
Public ContactChrister Groeben
Urologische Klinik der Universitätsklinik der Philipps-Universität Marburg
Outcome results
None listed