Prospective study on the treatment of congenital vaginal agenesis or vaginal hypoplasia - genital reconstruction, gynecological and urological aspects, psychosexual and social aspects and quality of life

Prospective study on the treatment of congenital vaginal agenesis or vaginal hypoplasia - genital reconstruction, gynecological and urological aspects, psychosexual and social aspects and quality of life - Prospective study treatment of congenital vaginal agenesis/hypoplasia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36303

Enrollment

545

Registered

2011-01-17

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Disorders of sex development hermaphroditism intersex

Interventions

Enlargement of the vagina by a self dilatation procedure

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Vaginal depth at the end of treatment Capability of penile-vaginal intercourse .	—

Secondary

Measure	Time frame
Satisfaction with sexual functioning	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)