1. Investigate the effects of gynecological pelvic surgery on vaginal innervation, vaginal vascularisation and pelvic floor tonus. 2. Investigate the effects of gynecological pelvic surgery on sexual and psychological well-being. 3. Investigate the…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective outcome measurements; vaginal innervation, vaginal vascularisation,
pelvic floor tonus.
Secondary outcome
Subjective outcome measurements; sexual well-being, presence of depression,
quality of lifre related to micturition and defecation.
Background summary
Little knowledge is available about the pathophysiological changes occurring
after gynecological pelvic surgery. Subjective changes measured by
questionnaires provide little insight into these pathophysiological changes.
More evidence about the pathophysiology of altered pelvic floor function may
help to modify surgical techniques and thus ultimately improve post-operative
pelvic floor function In the proposed study we measure vaginal innnervation,
vaginal vascularisation and pelvic floor tonus before and 6 months after
hysterectomy or prolapse surgery. Changes will be related to subjective changes
in sexual well-being.
Study objective
1. Investigate the effects of gynecological pelvic surgery on vaginal
innervation, vaginal vascularisation and pelvic floor tonus.
2. Investigate the effects of gynecological pelvic surgery on sexual and
psychological well-being.
3. Investigate the relation between vaginal innervation, vaginal
vascularisation and pelvic floor tonus on one side and changes in sexual and
psychological well-being on the other side.
Study design
A pilot study will be perforned in 10 women undergoing vaginal prolapse
surgery, 10 women undergoing vaginal hysterectomy and 10 women undergoing
abdominal hysterectomy.
Study burden and risks
Patients visit 4 times the hospital. Each visit takes 90 minutes during which
time questionnaires are completed. During 2 of the 4 visits also measurements
are performed. Measurements are performed using a vaginal probe. This probe is
inserted by the patient self. Vaginal innervation, vaginal vascularisation and
pelvic floor tonus are measured both with and without administration of a
visual erotic stimulus. These measurements are proven tob e safe, not painful
and are reported to be not bothersome by women participating in similar
studies.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Patients planned to undergo prolapse surgery.
2. Patiente planned to undergo hysterectomy.
Exclusion criteria
1. Patients with previous pelvic surgery.
2. Patients with traumatic sexual experiences.
3. Patiens with history of a 3rd or 4th degree perineal tear.
4. Age < 18 years
5. Previous median laparotomy / other large surgical scar
6. History of bowel resection of vulva surgery.
7. Diabetes Mellitus
8. Preëxistent sexual disfunction.
9. Medical treatment which may affect the sexual response. (psychofarmaca, antihypertensiva)
10. Depressive disorder (a score of > 20 on the Beck Depression Inventory
11. (severe) post-operative complication
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 | NL16529.018.07 |