The present study will investigate vaginal blood flow, measured by vaginal photoplethysmography, in pre- and post-menopausal women affected with DM type 1, and in an age and menopausal status matched sexually functional control group. Changes in…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gonadotrophin and sex hormone changes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome of vaginal photoplethysmography en subjective sexual arousal
measurement.
Secondary outcome
report of sexual problems
Background summary
Erectile dysfunction is a well-established complication of diabetes mellitus
(DM), with the prevalence increasing with age[1]. The sexual function of women
with DM has received much less attention in clinical research. However, recent
controlled prevalence studies indicate that DM increases the risk of female
sexual dysfunction, primarily sexual arousal and lubrication problems[2-4]. The
pathophysiology of DM-associated sexual dysfunction in men is known to include
endothelial and smooth-muscle dysfunction and autonomic neuropathy[1]. In
women, micro vascular and neuropathic complications may also play a role in
sexual dysfunction. In view of the evidence for decreased sexual arousal and
lubrication in women with DM, research applying objective physiological
measures of sexual response in this population seems highly useful. To date,
only few studies included such measures. One very small study measured vaginal
blood flow by vaginal photoplethysmography and observed reduced vaginal blood
flow in diabetic women[5]. Other studies observed reduced baseline clitoral
blood flow in women affected with DM [6], and decreased genital vibration sense
[7]. Taken together these studies indicate diminished genital vascular
responsiveness and genital tactile sensitivity in women with DM. However, to
establish and extend research findings further research is necessary.
Study objective
The present study will investigate vaginal blood flow, measured by vaginal
photoplethysmography, in pre- and post-menopausal women affected with DM type
1, and in an age and menopausal status matched sexually functional control
group. Changes in vaginal blood flow and subjective sexual arousal in response
to visual erotic and clitoral vibrotactile stimulation will be measured. Also
the association between DM complications and sexual responsiveness will be
investigated.
Study design
All women will visit the hospital one time. During this visit they will fill in
questionnaires about socio-demographic variables, sexuality and psychological
functioning and for women older than 40 this it will include a venous blood
sample. For diabetic women the visit will include also a limited neuro-vascular
assessment and determination of HBAC level. All participants will go through a
1-hour experimental session with vaginal photoplethysmography. For diabetic
women, data on duration of disease and vascular complications will be retrieved
form the medical records.
Study burden and risks
After they have given written acknowledgement of informed consent to
participate, a medical and psychiatric screening will take place. The
participants will receive a financial compensation for their participation in
the study; diabetic women will receive ¤65,-, and control women will receive
¤45,-. A proportional payment will be made when the volunteer leaves on her own
wish before study completion, or when, based on the screening, the participant
is asked by the investigators to discontinue the study for medical or
psychiatric reasons. The amount of the financial compensation is based on the
standard compensations that are generally accepted in this field of research.
Travel expenses will be compensated with a maximum of ¤45,-.
The vaginal photoplethysmograph used in this study is considered a safe device.
No harmful events have been reported. Furthermore, the device used to measure
genital arousal and the vibrator will be sterilized before each use, according
to plasma sterilization procedure. From previous studies in our laboratory it
is known that the genital vibrotactile stimulation will not cause harm or
discomfort.
Albinusdreef 2, Postbus 9600
2300 RC Leiden
NL
Albinusdreef 2, Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
1) are >= 18 < 70 years old, 2) have DM type 1, 3) have a heterosexual orientation
Exclusion criteria
homosexual orientation (because of the heterosexual erotic stimuli), pregnancy or lactation, a diagnosis of affective, psychotic or substance related disorder according to DSM-IV-TR, having undergone a hysterectomy or prolapse surgery, current use or recent use (less than 4 weeks before participation) of medication that may affect sexual response, disorders of the genitals that may influence the sexual response or the measurement of the response, and other medical disorders than DM that may influence the sexual response or the measurement of the response
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30753.058.09 |