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Pelvic organ prolapse, self-image and acceptance

Pelvic organ prolapse, self-image and acceptance: a multi-center and cross-sectional observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24158
Enrollment
189
Registered
2019-07-26
Start date
2019-08-05
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

Pelvic organ prolaps and diabetes mellitus type 2

Interventions

none

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All groups: Women, 40 - 70 years of age, in a heterosexual relationship with sexual contact including penetration Pelvic organ prolaps group: • Pelvic organ prolapse POP-Q stadium 2, no further differentiation in stadium Diabetes mellitus type 2 group: • Subjects have diabetes mellitus type 2. Healthy women group Male partner from every group: • 40 - 70 years of age.

Exclusion criteria

Exclusion criteria: All groups: subjects that are not able to give informed consent and subjects who do not understand Dutch Diabetes mellitus type 2 group: • Polyneuropathy caused by diabetes mellitus • Macro vasculopathies caused by diabetes mellitus, defined as: - Cerebrovascular accident - Myocardial infarction - Peripheral vascular disease - Suspicion of vasculopathies by clinician on the basis of physical examination and anamnesis • Primary hypogonadism Healthy women group: • Subjects with pelvic organ prolapse or diabetes mellitus. Male partners from every group: • Pre-existing sexual dysfunction including erectile dysfunction

Design outcomes

Primary

MeasureTime frame
1.To determine if and in what way the pelvic organ prolapse influences the sexual function and the self-image of the patient 2.To compare the POP group and the control group on level of sexual function and (sexual) self-concept and to determine whether potential differences are specific to the POP group or can be attributed to disease awareness by comparing the sexual function and (sexual) self-concept between patients with POP and controls, and compare the results to differences between patients with diabetes mellitus type 2 and controls.

Secondary

MeasureTime frame
1. To determine the level of agreement between the self-concept of the female participant and the self-concept as perceived by the partner 2. To determine whether level of agreement between female participant and partner is associated with quality of life, relationship and sexual outcomes. 3. To determine whether the quality of life is related to the symptoms of pelvic organ prolapse or chronic disease. 4. To compare the self-image of the women with the self-image of their partners 5. To compare the quality of life of the partner of the chronic disease group with the quality of life of the partner of the healthy control group

Contacts

Public ContactCarlijn Smeets

Radboud UMC

carlijn.smeets@radboudumc.nl+31648666090

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)