ejaculatory dysfunction premature and delayed ejaculation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: General inclusion criteria (Male Subject: M / Female Partner: F) • 18 years or older (but not over 65): M+F • Involved in a sexual relationship for at least six months: M+F • Signed informed consent: M+F • Cooperative, able to follow instructions: M+F • capable of lying still: M • Normal hand function: F • Heterosexual: M ;Subject inclusion for phase 2 (fMRI experiment) on basis of sexological assessment • Men with IELT 15 min & significant subjective complaints (assigned to RE group) • Men with IELT 2-6 min & no significant complaints (assigned to Healthy group) • Free plasma testosterone within normal range (12-26 nmol/l) • No history of sexual abuse
Exclusion criteria
Exclusion criteria: General exclusion criteria (Male Subject: M / Female Partner: F) • MRI contraindications (specified for M and F in separate questionnaire) • outside normal range on personality questionnaire: M+F • Any psychiatric, somatic or neurological disorders which may affect the Central Nervous System or influence study outcome: M • Claustrophobia, or difficulty in having head restrained: M • Poor motor control, or any condition that interferes with precise hand movements: F • Receiving treatment for ejaculatory complaints: M • Penile circumcision: M • Pregnancy or the possibility to be pregnant: F;Criteria leading to exclusion on the day of the fMRI experiment • When subjects report to have ejaculated in the 24hr prior to the fMRI experiment • When subjects report recreative drug intake (e.g. cocaine, marihuana, ecstacy) in the last two weeks prior to the fMRI experiment • When subjects report alcohol intake in the 24hr prior to the fMRI experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are changes in brain (so-called BOLD) responses to penis stimulation and pelvic floor contraction, and structural brain information about white matter density (so-called fractional anisotropy, FA) provided by the DTI scans. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints: Behavioural and genetic differences between groups and their relation to the measured BOLD response and white matter signal. | — |
Countries
Netherlands