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Patient research anatomy and pessary therapy

Patient research anatomy and pessary therapy - PRAP-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41878
Enrollment
20
Registered
2015-09-03
Start date
2016-06-03
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

descensus prolapse

Interventions

Pessary therapy
Prolapse

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Women with an anterior vaginal wall prolaps and/or prolapse of the cervix minimal POP-Q stage II, who are minimal one year treated with pessarytherapy and have no more prolapse complaints and where the pessary shows a good corrections of the prolapse. - Woman with an anterior vaginal wall prolaps and/or prolapse of the cervix minimal POP-Q stage II, who choose pessarytherapie, but it is not possible to find a pessary that show a good correction of the prolapse and give no more prolapse complaints.

Exclusion criteria

Exclusion criteria: - Age of 18 years or more - Patients who are mentally incompetent - Patients with a posterior vaginal wall prolaps as leading part and where the posterior vaginal wall prolaps the indication is for therapy - Patients with former prolapse surgery - Contra-indications for MRI

Design outcomes

Primary

MeasureTime frame
Surface of the hiatus Pubococcygeal line, length cervix, transvaginal length, diameter and defect musculus levator ani

Secondary

MeasureTime frame
Possible secondary outcomes are: pubococcygeale line, cervix length , transvaginal length , diameter and defect musculuis levator ani in relation to a standard pessary. The final secondary outcomes, we can not determine yet. The final secondary outcomes will be explored during the analysis of the MRI images .

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)