Evaluation study on the effectiveness of a new developed vaginal dilatation programme for medical-psychological treatment of vaginal hypoplasia / agenesis.
ID
Source
Brief title
Condition
- Reproductive tract and breast disorders congenital
- Congenital reproductive tract and breast disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vaginal depth at the end of treatment
Capability of penile-vaginal intercourse
.
Secondary outcome
Satisfaction with sexual functioning
Background summary
Females with DSD, such as 46 XX Mayer-Rokistansky-Kuestner-Hauser syndroom,
congenital adrenal hyperplasia, 46 XY and androgen insensitivity, disorders in
the biosynthesis of testosterone and different types of gonadal dysgenesis have
been born with vaginal hypoplasia or agenesis. In these women penile-vaginal
intercourse will be impossible. For the large majority of men and women,
engagements in sexual relationships contribute significantly to their quality
of life. Females with DSD experience such needs too. Before entering such
relationships, they need a treatment to normalise the functionality of their
vagina's.
A functional vagina can be created by surgical vaginoplasty and vaginal
dilatation. At present, guidelines for medical treatment have not been
developed. There is consensus that psychological counselling should be offered
to these women, but guidelines for psychological counselling neither have been
developed. The gender team of UZ Gent and the ErasmusMC team for diagnostics
and treatment of disorders of sex development have developed a treatment
existing in both medical treatment and psychological counselling.
Study objective
Evaluation study on the effectiveness of a new developed vaginal dilatation
programme for medical-psychological treatment of vaginal hypoplasia / agenesis.
Study design
Prospectieve studie in women with DSD en vaginal hypoplasia/agenesis who wish
to have a functional vagina. A programme of treatment have been designed
including education, instruction for self dilatation, psychological counselling
in the first to 4th untill the 12th months after the start of the treatment in
order to optimalize success of treatment
Intervention
Enlargement of the vagina by a self dilatation procedure
Study burden and risks
The psychological interview on motivation and psychosexual development, to fill
out questionnaires on (psycho)sexual functioning, self dilatation and
gynecological examinations can be a psychological burden.
Postbus 2060
3000 CB Rotterdam
NL
Postbus 2060
3000 CB Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Females with a disorder in sex development (DSD) and vaginal hypoplasia / aplasia
46 XY, and assigned and raised female
46, XX and assigned and raised female
Exclusion criteria
- female DSD patients who will not start vaginal dilatation therapy
- moderate to severe mental retardation (IQ below 55)
- younger than 12 years of age
Design
Recruitment
Medical products/devices used
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 | NL32973.078.10 |