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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

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 - Sexual and physiological functioning of MRKH women and their partners

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44138
Enrollment
400
Registered
2016-10-17
Start date
2015-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

MRKH syndrome
sexual arousal response
sexual functioning

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)