Primary Objective: 1. To determine if and in what way the pelvic organ prolapse influences the sexual function and the self-image of the patient2. To compare the POP group and the control group on level of sexual function and (sexual) self-concept…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Pelvic organ prolapse (POP) is a very common disorder among women. Studies show
that patients with POP report sexual dysfunction. A study shows that genital
self-image is associated with sexual dysfunction. POP directly involves the
female genitals and is likely to affect sexual identity. This may become a
threat to the sense of the self-concept, which may explain women*s fear and
negative experiences in sex. Despite its heuristic and clinical significance,
the sexual self-concept has received little research attention so far. It is
plausible to assume that not only POP, but also other chronic disease
influences the self-image and sexual functioning, therefore we want to
determine whether the sexual self-concept in relation to sexual function and
sexual experiences is specific to POP, or rather determined by general factors
related to being chronically ill. It is known that men with diabetes Mellitus
(DM) suffer from sexual dysfunction, the sexual function of women with DM on
the other hand is less known. The aim of this study is to determine whether and
to which extent the pelvic organ prolapse is associated with poor sexual
function in heterosexual couples and assess if it is comparable to patients
with diabetes mellitus when compared to healthy controls.
Study objective
Primary Objective:
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 Objectives:
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
Study design
This study is a cross-sectional, observational study in patients and their
partners with POP, diabetes mellitus type 2, and healthy controls.
Study burden and risks
not applicable
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
• Heterosexual relationship
• 40 - 70 years of age.
• Pelvic organ prolapse POP-Q stadium 2 or more
Exclusion criteria
• Subject that are not able to give informed consent
• Subjects who do not understand the Dutch lanquage
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL66252.091.19 |