The primary objective of this study is to asses the dynamic vaginal pressure profile in asymptomatic women. The secondary objective is to assess vaginal reflexes in asymptomatic women.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vaginal dynamic pressures, vaginal reflexes.
Secondary outcome
N.a.
Background summary
Anno 2012, there is still no consensus about the vaginal pressure profile in
asymptomatic women. Although various devices and techniques have been developed
to measure vaginal pressure, none of these techniques actually measured
absolute and dynamic pressure. Furthermore, the vaginal canal does not contain
one uniform pressure zone, but three different pressure segments (distal, mid,
proximal). Until now, the majority of studies have not attempted to distinguish
pressures in the different segments of the vaginal canal. We hypothesize that
dynamic vaginal pressure measurement can be a valuable tool to differentiate
between female sexual disorders like dyspareunia and vaginismus. Therefore, we
first want to determine the norms for dynamic vaginal pressure in asymptomatic
women. In the future, based on the pressure profile, vaginismus probably can be
distinguished from dyspareunia. The female reproductive tract is not simply a
passive conduit for the passage of the penis, foetus, semen and menses but a
responsive, active canal equipped with subtle reflectory activity. Taken the
embryology in consideration, the vaginal canal originates from the same germ
line as the anal canal. Therefore, we hypothesize that the vaginal canal might
have similar reflexes as the anal canal. At the University Medical Center in
Groningen a new technique with advanced microsensors has been developed to
measure absolute dynamic vaginal pressure in different segments of the vaginal
canal, and to measure vaginal reflexes as well.
Study objective
The primary objective of this study is to asses the dynamic vaginal pressure
profile in asymptomatic women. The secondary objective is to assess vaginal
reflexes in asymptomatic women.
Study design
An explorative study.
Study burden and risks
There are no risks associated with participation. For the vaginal tests, a thin
catheter will be placed in the vaginal canal. Next to that a small balloon will
be placed in the vagina and slowly inflated with water of body temperature. As
soon as the patient experiences pain, the tests will be stopped. The burden
mainly consists of the time it takes to fill out questionnaires and to undergo
the vaginal pressure- and reflex tests. Participants will receive a
compensation.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Asymptomatic women
Subjects need to be 18 years or older (but not over 45 years)
Subjects need to be nulliparous
Subjects need to be able to read the Dutch language
Subjects are required to give signed informed consent
Exclusion criteria
Pregnant women
Women with a history of pelvic floor trauma/operations
Women with sexual transmitted diseases
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 | NL39767.042.12 |