Prolapse
Conditions
Interventions
 
N/A (de pelvic floor function will be investigated to gain insights in the support mechanism of a pessary) 
Sponsors
Ziekenhuis Groep Twente (ZGT)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet the following criteria: o Good knowledge of Dutch language o Women >=18 years of age o Signed informed consent Additional inclusion criteria for the different groups: - Successful pessary fitting (*happy pessary users*): o Symptomatic stage >=2 POP on POP-Q (physical examination) o Continued ring pessary (open or closed/supported) usage for >=3 months - Unsuccessful pessary fitting (*unhappy pessary users*): o Symptomatic stage >=2 POP on POP-Q o Unsuccessful fitting of a ring pessary (open or closed/supported): dropping out of the pessary within 7 days or discontinuation due to uncomfortable fit. - Healthy volunteers: o Parous (at least 1 vaginal delivery)
Exclusion criteria
Exclusion criteria: Previous prolapse surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the difference in pelvic floor muscle function between POP patients with successful pessary fitting, with unsuccessful pessary fitting, and healthy volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints: • The differences, correlations, and relations between in pelvic floor muscle function measurements tools: 4D TPUS derived strain and myofeedback measurements (MAPLe) • Relationship between the functional measurements (TPUS, MAPLe and TMSI) and the clinical symptoms (PFIQ-7 and PDFI-20) • Anatomical differences between POP patients with successful pessary fitting, with unsuccessful pessary fitting, and healthy volunteers | — |
Countries
Netherlands
Contacts
Public ContactJ.A. Simmering
Ziekenhuis Groep Twente (ZGT)
Outcome results
None listed