Objective(s): The primary objective of this study is to asses the dynamic vaginal pressure profile in two groups: 1) women diagnosed with dyspareunia and, 2) women with primary vaginismus. The secondary goal is to assess vaginal reflexes in women…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Vaginal dynamic pressures, vaginal reflexes.
Secondary outcome
Not applicable.
Background summary
Female sexual pain disorders are divided into two groups, dyspareunia and
primary vaginismus. Both diagnoses are based on clinical symptoms. The
assumption that dyspareunia and primary vaginismus are indeed two distinct
types of sexual pain disorders has been challenged, since patients often have
features of both conditions.
At the University Medical Center in Groningen a new technique with advanced
micro sensors has been developed to measure absolute dynamic vaginal pressure
in different segments of the vaginal canal, and to measure vaginal reflexes as
well. At this moment norms for absolute and dynamic vaginal pressure and
vaginal reflexes in asymptomatic women are being determined in a number of
asymptomatic women.
We hypothesize that absolute and dynamic vaginal pressure measurements can be a
valuable tool to differentiate between dyspareunia and primary vaginismus. We
hypothesize that in the future, based on the vaginal pressure profile,
dyspareunia can be distinguished from primary vaginismus. Moreover, detailed
knowledge about the vaginal pressure profile, and vaginal reflexes in both
groups can lead to more effective treatments.
Study objective
Objective(s): The primary objective of this study is to asses the dynamic
vaginal pressure profile in two groups: 1) women diagnosed with dyspareunia
and, 2) women with primary vaginismus. The secondary goal is to assess vaginal
reflexes in women diagnosed with dyspareunia and women with primary vaginismus.
Study design
Study design: An explorative study.
Study burden and risks
For both study groups there are no risks associated with participation in this
study. For the vaginal tests, a thin catheter will be placed in the vaginal
canal. In addition, a small balloon will be placed in the vaginal canal and the
balloon will slowly be 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.
Hanzeplein 1 1
Groningen 9700 RB
NL
Hanzeplein 1 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
• Women diagnosed with dyspareunia or primary vaginismus
• Subjects aged between 18-45 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
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 | NL41571.042.12 |