1. To assess the effects of prolapse surgery on vaginal nerve density2. To measure the association between changes in vaginal nerve density and changes in pelvic floor function
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effects of prolapse surgery on vaginal nerve density quantified in vaginal
epithelial layer biopsies (diameter 4 mm) taken before surgery and at 6 weeks
and 6 months after surgery. Biopsies will be taken from the vaginal epithelial
layer at both the operated compartment and the opposite vaginal wall.
Secondary outcome
Pelvic floor function measured using the UDI-6, IIQ-7 and PISQ-12
questionnaires before and 6 months after surgery.
Background summary
Vaginal prolapse surgery is intended to restore abnormal pelvic floor function
by restoring anatomical abnormalities of the vagina and its surrounding
visceral organs. The surgical trauma that occurs during such correction may
result in damage to vaginal innervation and vascularisation which could explain
why pelvic floor dysfunction persists or develops in some patients who undergo
vaginal prolapse surgery. Our group developed a validated technique to measure
the sensibility of the vaginal wall. It is possible that this technique
measures more than the vaginal sensibility alone because measurements can be
influenced by other neurological or emotional factors like concentration,
sensibility input from other parts of the body, anticipation to a stimulus etc.
To objectively assess the effect of surgical trauma on the vaginal sensibility
we propose a study where we will measure the vaginal nerve density before and
after prolapse surgery.
Study objective
1. To assess the effects of prolapse surgery on vaginal nerve density
2. To measure the association between changes in vaginal nerve density and
changes in pelvic floor function
Study design
An observational prospective pilot study
Study burden and risks
Before surgery biopsies will be taken under general anaesthesia therefore
causing no extra burden. Surgery time will not be prolonged and there is no
expectation that taking two biopsies will influence prolapse surgery. During
the follow-up at six weeks (routine post-operative consultation) and six months
(one extra visit) after surgery two biopsies will be taken under local
anaesthesia in a controlled clinical setting. Informed consent will be
obtained.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Patients undergoing primary prolapse surgery because of vaginal prolapse stage * 2 in either the anterior or posterior compartment.
- Sexually active women, sexually active meaning:
o Patients who are sexually active before surgery
o Patients who are not sexually active before surgery but plan to become sexually active after surgery
Exclusion criteria
- Previous pelvic surgery
- Previous pelvic irradiation
- Unwilling to return for follow-up or language barriers
- Presence of immunological / haematological disorders interfering with recovery after surgery
- Neurologic disorders, neuropathy
- Abnormal ultrasound findings of uterus or ovaries.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL40356.018.12 |
| OMON | NL-OMON22450 |