Sexual functioning in women with the Mayer-Rokitansky-Küster-Hauser syndrome (MRKH syndrome) and their partners and physiological sexual arousal responses in these women with a surgical or non-surgical created neovagina

Suspended

Conditions: seksuele (dis)functie(s)
Mayer-Rokitansku-Kuster-Hauser syndrome
Mullerian agenesis syndrome
10038608

Registration Number: NL-OMON44138

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 400

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p><br /><br>Part 1<br /><br>Sexual functioning within a heterosexual relationship, measured with validated<br /><br>questionnaires ( * * Female sexual function index (FSFI), Female sexual<br /><br>distress scale (FSDS), ; **International Index of erectile function (IIEF),<br /><br>Male sexual distress scale (MSDS)).<br /><br><br /><br>Part 2<br /><br>Genital sexual arousal, measured with vaginal photoplethysmography that<br /><br>assesses changes in vaginal pulse amplitude (VPA), reflecting the phasic<br /><br>changes in vaginal engorgement during an experimental session; subjective<br /><br>sexual arousal measured through self-reported ratings of sexual arousal<br /><br>collected after the neutral and the erotic stimuli; </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>Sexual self image measured with the Rosenbergs Self Esteem Scale (RSES),<br /><br>Sexual Esteem Scale (SES) and Female Genital Self-image Scale (FGSIS) (only for<br /><br> ) .<br /><br>Psychological functioning assessed with the Symptom Checklist (SCL)-90 and<br /><br>Hospital Anxiety and Depression Scale (HADS) ( for * and *).<br /><br>Relational functioning by assessment of relationship satisfaction using the<br /><br>Maudsley Marital Questionniare (MMQ) ( for * and **).<br /><br>Evaluation of an association between sexual functioning of MRKH women and these<br /><br>secundary outcome variables<br /><br><br /><br>Part 2:<br /><br>Evaluation of a possible association between the kind of treatment ( surigal<br /><br>versus non surgical) and changes in vaginal blood flow; an association between<br /><br>the kind of surgery and vaginal blood flow responses will be examined<br /><br>exploratorily.</p><br>