Objective: To determine the effect of a MiniArc procedure on female sexual function in relation to the surgical procedure and it's treatment result. Also to evaluate the determinants of this effect.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
seksuele functie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A. To determine the effect of a MiniArc procedure on female sexual function in
relation to the surgical procedure and it's treatment result.
B. Also to evaluate the determinants/causal factors of this effect.
Secondary outcome
Parameters/outcome:
• anwsers to the general questions
• the (subjective) treatment result
• total score FSFI preoperatively compared to postoperatively
• subscores of the GRISS preoperatively compared to postoperatively
• subscores of the GRISS of the partner preoperatively compared to
postoperatively
• anwsers to the questions about sexuality by the partners preoperatively
compared to postoperatively
Background summary
Background: Surgical treatment of stress urinary incontinence may have a
positive or negative effect on female sexual function. The MiniArc procedure is
a relatively new procedure and has a 'single incision approach' which is
minimal invasive.
The effect of the MiniArc procedure on female sexual function has not yet been
evaluated.
Study objective
Objective: To determine the effect of a MiniArc procedure on female sexual
function in relation to the surgical procedure and it's treatment result. Also
to evaluate the determinants of this effect.
Study design
Methods: Prospective multicentre questionnaire study.
Materials: Questionnaires. First general questions, then the validated Female
Sexual Function Index, the Female Sexual Distress Scale and the Golombok Rust
Inventory of Sexual Satisfaction. Also a questionnaire for the partner of the
patient (Golombok Rust Inventory of Sexual Satisfaction for men).
Study burden and risks
Not burden or risks.
Albinusdreef 2
2333 ZA, Leiden
Nederland
Albinusdreef 2
2333 ZA, Leiden
Nederland
Listed location countries
Age
Inclusion criteria
- female patients who will undergo the MiniArc procedure for stress urinary incontinence
- >18 years old
- in a relationship with a partner
Exclusion criteria
- medical histery of vaginal surgery
- <18 years old
- patients who do not speak Dutch
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 | NL26877.058.09 |