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Pelvic organ prolapse, self-image and acceptance

Pelvic organ prolapse, self-image and acceptance - PROSA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48949
Enrollment
195
Registered
2019-07-17
Start date
2020-01-14
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

cystocele Pelvic organ prolapse

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Heterosexual relationship • 40 - 70 years of age. • Pelvic organ prolapse POP-Q stadium 2 or more

Exclusion criteria

Exclusion criteria: • Subject that are not able to give informed consent • Subjects who do not understand the Dutch lanquage

Design outcomes

Primary

MeasureTime frame
Study parameters/endpoints To assess the study outcomes, a questionnaire will be completed both by the patient and her partner. We will make sure that both partners complete the questionnaires independently to limit issues of social desirability or positive partner biases. Because being in a heterosexual relationship is one of the inclusion criteria, the questionnaire for the partner is specific to male participants. Main study parameter/endpoint The main study endpoint is the score on the Female Sexual Function Index (FSFI), for women in the POP group, the DM type 2 group, and the control group.

Secondary

MeasureTime frame
Secondary study parameters/endpoints Sexual function in men with the international index of erectile function (IIEF), body image using the Body Image Scale and genital body image using the female genital self-image scale (FGSIS), sexual distress with the Female Sexual Distress Scale (FSDS-R), sexual self-concept measured using an adapted version of the Sexual Self Scale of Snell, self-esteem using the Rosenberg Self-Esteem Scale, Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS), and Quality of Life (QoL) measured using the SF-36.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)