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Central mechanisms of ejaculatory dysfunction: a multi-modal fMRI investigatio

Completed
Conditions
ejaculatory dysfunction
premature and delayed ejaculation
10040480
10013356
Registration Number
NL-OMON39680
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
164
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 < 30s & significant subjective complaints (assigned to PE group)
• 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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Main study parameters are changes in brain (so-called BOLD) responses to penis<br /><br>stimulation and pelvic floor contraction, and structural brain information<br /><br>about white matter density (so-called fractional anisotropy, FA) provided by<br /><br>the DTI scans. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary study parameters/endpoints: Behavioural and genetic differences<br /><br>between groups and their relation to the measured BOLD response and white<br /><br>matter signal.</p><br>
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