Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39680
Enrollment
164
Registered
2011-11-29
Start date
2012-06-22
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ejaculatory dysfunction premature and delayed ejaculation

Interventions

The intervention entails mild stimulation of the glans penis. Stimulation will occur in a standardized way, and is not aimed to induce feelings of sexual arousal in he subject. Stimulations will be

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)