The purpose of this study is to investigate whether the hyperactive pelvic floor syndrome can be assessed by objective measurement. This will be done by means of a newly developed instrument, the so-called VPA/EMG/sensibility-combiprobe, that…
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
It is expected that
- the control group will show a larger EMG increase during the voluntary
control excercises than the experimental group;
- the control group will exhibit lower tonus- and higher controlscores in the
pelvic floor exam than the experimental group;
- both groups of women will show hightened EMG activity during the threatening
and sexually threatening film clips;
- both groups of women will demonstrate hightened VPA amplitude during the
erotic flm clip compared to baseline, but the experimental group*s VPA will be
lower than the control group*s VPA;
- women with an increased tonus of the pelvic floor will have a lower threshold
for perceiving stimuli (they will exhibit increased vaginal innervation)
Secondary outcome
It is expected that little control over the pelvic floormuscles as measured in
the pelvic floor exam will be related to a reduced EMG variability during the
flick excercises.
Background summary
Pelvic Floor hypertonicity is a chronic, nearly always involuntary, increased
activity and/or tension of the pelvic floor muscles. This may be the cause of
various gynaecological, sexological and urological complaints. Hyperactive
pelvic floor syndrome is diagnosed when 1) there is clinical evidence of pelvic
floor hypertonicity and 2) co-morbidity with three or more symptoms
co-occurring with pelvic floor dysfunction such as chronic abdominal pain,
irritable bowel syndrome, diarrhea, dyspareunia, vulvodynia and sexual arousal
disorder. The hightened activity and constant tension of the pelvic floor cause
the muscles to become fatigued which may lead to problems with conscious muscle
contractions.
Study objective
The purpose of this study is to investigate whether the hyperactive pelvic
floor syndrome can be assessed by objective measurement. This will be done by
means of a newly developed instrument, the so-called
VPA/EMG/sensibility-combiprobe, that measures activity of the pelvic floor
(EMG) in combination with vaginal vasocongestion (VPA) and innervation of the
vaginal wall.
Study design
Ten premenopausal women with the hyperactive pelvic floor syndrome and 10
premenopausal healthy women without any sexual or pelvic floor symptoms are
studied by a physician-sexologist in a pelvic floor exam and by a female
experimenter in the psychophysiological laboratory. In the pelvic floor exam
functionality of the pelvic floor muscles is assessed by means of the Pelvic
Floor Index (PFI) and a pressure-measurement by means of a balloon. In the
psychophysiological laboratory voluntary and involuntary control of the pelvic
floor muscles as well as vaginal vasocongestion and innervation is measured by
means of the combiprobe. Involuntary control of the pelvic floor muscles is
measured during neutral, erotic, threatening and sexually threatening film
clips. Voluntary control is measured by means of flick and hold contractions of
the pelvic floor muscles..
Study burden and risks
Several parts of this study may be perceived as unpleasurable, such as the
vaginal exam of the physician-sexologist, insertion of the vaginal probe and
being exposed to the film clips. In using the balloon the subject*s pain
thresholds are not exceeded. The risk of pain at insertion of the vaginal probe
is considered small, since it is a small instrument (in shape and size
comparable to a menstrual tampon) which is constructed of smooth material.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria both groups:
1. No sexual compaints for at least one year and sexually active.
2. Heterosexual orientation.
3. Willing to provide informed consent.
4. Control group: Subjects are medically healthy and have no complaints that point to problems with the pelvic floor.
5. Pelvic floor hypertonia group: Dyspareunia and co-morbidity of three or more symptoms that corrrelate with pelvic floor dysfunctions such as chronic abdominal pain, irritable bowel syndrome, constipation, diarrhea, urethra syndrome, overactive bladder, intercistal cystitis, vulvodynia, sexual arousal disorder, peri-anal pain, haemorrhoids, perineal pain, coccydynia, orgasm pain, lower back pain, muscle ache in other body parts such as neck or shoulders, headache, teeth gnashing, hyperventilation.
Exclusion criteria
Exclusion criteria both groups:
1. Sexual complaints of shorter duration than one year.
2. Pregnancy and lactation.
3. Menstruation during measurement days.
4. Use of medication negatively influencing sexual function or vaginal vasocongestion.
5. Use of drugs 24 hours prior to testing.
6. Affective, psychotic, or substance-abuse disorders.
7. Pelvic floor hypertonia group: chronic pelvic floor hypertonia with generalized secundary vaginismus.
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 | NL16600.018.07 |