The study comprises 2 parts.Part 1: Primary: to assess sexual functioning, sexual self image and psychological and relational functioning in MRKH women with surgical or non- surgical created neovaginas and their partners and make a comparison with…
ID
Source
Brief title
Condition
- Other condition
- Reproductive tract and breast disorders congenital
Synonym
Health condition
seksuele (dis)functie(s)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1
Sexual functioning within a heterosexual relationship, measured with validated
questionnaires ( * * Female sexual function index (FSFI), Female sexual
distress scale (FSDS), ; **International Index of erectile function (IIEF),
Male sexual distress scale (MSDS)).
Part 2
Genital sexual arousal, measured with vaginal photoplethysmography that
assesses changes in vaginal pulse amplitude (VPA), reflecting the phasic
changes in vaginal engorgement during an experimental session; subjective
sexual arousal measured through self-reported ratings of sexual arousal
collected after the neutral and the erotic stimuli;
Secondary outcome
Part 1:
Sexual self image measured with the Rosenberg*s Self Esteem Scale (RSES),
Sexual Esteem Scale (SES) and Female Genital Self-image Scale (FGSIS) (only for
* *) .
Psychological functioning assessed with the Symptom Checklist (SCL)-90 and
Hospital Anxiety and Depression Scale (HADS) ( for * * and **).
Relational functioning by assessment of relationship satisfaction using the
Maudsley Marital Questionniare (MMQ) ( for * * and **).
Evaluation of an association between sexual functioning of MRKH women and these
secundary outcome variables
Part 2:
Evaluation of a possible association between the kind of treatment ( surigal
versus non surgical) and changes in vaginal blood flow; an association between
the kind of surgery and vaginal blood flow responses will be examined
exploratorily.
Background summary
Surgical as well as non- surgical treatment is offered to create a neovagina in
women affected with the Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome (uterus
and vagina agenesis). Assessment of sexual functioning after treatment yields
conflicting results. It can be questioned whether sexual functioning of these
women is affected by hampered sexual self image, by impaired psychological or
relational functioning, by partners' sexual dysfunction or by a reduced sexual
response of their neovaginas from a physiological point of view.
Study objective
The study comprises 2 parts.
Part 1: Primary: to assess sexual functioning, sexual self image and
psychological and relational functioning in MRKH women with surgical or non-
surgical created neovaginas and their partners and make a comparison with the
results of age-matched women without the condition and their partners.
Secondary: to evaluate an association between sexual functioning and sexual
self image, psychological and relational functioning
Part 2: Primary: to investigate genital arousal using vaginal
photoplethysmography and subjective sexual arousal in pre-menopausal MRKH women
compared with age-matched women without the condition when confronted with
neutral and erotic film exerpts. Secondary: to evaluate differences in genital
and subjective sexual arousal responses between the surgically and
non-surgically reconstructed neovaginas and to explore an association between
vaginal blood flow responses and the kind of surgery that was performed to
create a neovagina
Study design
case control study
Study burden and risks
Part 1: All eligible MRKH women, age-matched control women and their partners,
who have consented for study participation complete a set of questionnaires
about socio-demographic variables, sexual functioning, sexual self image,
psychological and relational functioning via a personal portal on a licensed
version of Netquestionnaires 6.0 or are provided with the paper and pencil
version of the questionnaires.
Part 2: All female participants, MRKH and control women, will visit the
hospital (LUMC) one time and go through a 1-hour experimental session with
vaginal photoplethysmography. Before the start all women will undergo a
gynaecological examination to assess length of their (neo)-vagina.
Vaginal photoplethysmography does not cause harm or discomfort. Self-insertion
of the plethysmograph (with the size of a menstruation tampon) and completion
of questionnaires about sexual functioning and sexual self image may be
experienced as uncomfortable
Albinusdreef 2
Leiden 2333 AA
NL
Albinusdreef 2
Leiden 2333 AA
NL
Listed location countries
Age
Inclusion criteria
All participants must have a sexual relation with a male partner for at least six months. Furthermore,
Part 1, questionnaire study: All MRKH women with a neovagina, surgically as well as non surgically created, are invited. Control women are healthy females without the condition, age-matched with the study population. Via these women their partners are asked to participate.
Part 2: psychophysiological assessment:
Those MRKH as well as control women, participants of part 1 of the study, and aged between 18-45 years old.
Exclusion criteria
For part 1 & 2:
unable to speak, understand and write the Dutch language
pregnancy or lactation (control women only);Only for part 2
* the depth of the neovagina is too small to carry the probe for the photoplethysmographic device ( MRKH women only)
* having a disease that is known to affect genital response (such as Diabetes Mellitus, Multiple Sclerosis, Radical hysterectomy).
* current use or recent use (less than 4 weeks before participation) of medication that may affect genital responses.
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 | NL52000.058.15 |