Change in the International Index of Erectile Function (IIEF-5) for men or Female Sexual Function Index (FSFI) for women questionnaire to assess sexual health and erectile function
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
The IIEF-5 is a 15-item self-evaluation scale; it provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction.
The FSFI is a 19-item self-reporting questionnaire; it measures dimensions such as desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual activity.
Change in the Patient Health Questionnaire (PHQ) -9 questionnaire to assess mood changes
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
The PHQ-9 tool may reflect patients' accounts of their experiences of depression and to assess severity of and treatment response. Each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
Change in the Patient Health Questionnaire (EQ-5D-5L) questionnaire to assess quality of life
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). The second part of the questionnaire comprises a standard vertical 20-cm VAS that is calibrated from 'the worst health you can imagine' (scored 0) at its base to 'the best health you can imagine' (scored 100) at its apex.
Change in retinal vessel diameters to assess microvascular endothelial functioning
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
Change in retinal vessel diameters with the Static Retinal Vessel Analyzer (SVA-T, Imedos Systems UG, Jena, Germany). The system consists of a fundus camera (Topcon TRC NW8) and analyzing software (Visualis 3.2, Imedos Systems UG), allowing non-invasive and non-mydriatic assessment of retinal vessel diameters.
Change in Oxytocin Level (IU) (hormone of the reproductive axis)
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
Oxytocin Level (hormone of the reproductive axis) will be measured in the blood.
Change in semen concentration
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
Change in semen concentration
Change in peak oxygen consumption during spiroergometry to assess physical fitness
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
Change in peak oxygen consumption during spiroergometry
Change in maximum heart rate during spiroergometry
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
Change in maximum heart rate during spiroergometry
Change in the Freiburg questionnaire for physical activity (FQPA)
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
The questionnaire consists of 12 items and allows a calculation of weighted metabolic equivalent tasks (MET) hours per week. The Physical Activity Questionnaire (FPAQ) is used to measure physical activity. Individuals are considered physically active when they achieved metabolic equivalent tasks (MET) minutes of 600 or more per week.
Change in Testosterone level (nmol/l) (hormone of the reproductive axis)
Time frame · At baseline (before start of treatment, at V1) and after 4-6 months of treatment (V2)
Testosterone level (hormone of the reproductive axis) will be measured in the blood.