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Effects of vaginal prolapse surgery on innervation of the vagina.


- candidate number13196
- NTR NumberNTR3558
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2012
- Secondary IDsNL40356.018.12 / 2012_108; CCMO / METC AMC
- Public TitleEffects of vaginal prolapse surgery on innervation of the vagina.
- Scientific TitleEffects of vaginal prolapse surgery on innervation of the vagina.
- ACRONYMVIVA trial
- hypothesisVaginal 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.
- Healt Condition(s) or Problem(s) studiedSurgery, Prolapse, Vagina, Innervation
- Inclusion criteria1. Patients undergoing primary prolapse surgery because of vaginal prolapse stage ≥ 2 in either the anterior or posterior compartment;
2. Sexually active women, sexually active meaning:
A. Patients who are sexually active before surgery;
B. Patients who are not sexually active before surgery but plan to become sexually active after surgery.
- Exclusion criteria1. Previous pelvic surgery;
2. Previous pelvic irradiation;
3. Unwilling to return for follow-up or language barriers;
4. Presence of immunological / haematological disorders interfering with recovery after surgery;
5. Neurologic disorders, neuropathy;
6. Abnormal ultrasound findings of uterus or ovaries.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2012
- planned closingdate1-aug-2013
- Target number of participants10
- InterventionsVaginal nerve density will be 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.
- Primary outcomeThe 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.
- Secondary outcomePelvic floor function measured using the UDI-6, IIQ-7 and PISQ-12 questionnaires before and 6 months after surgery.
- TimepointsBiopsies will be taken before surgery and at 6 weeks and 6 months after surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRationale:
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.

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 population:
Sexually active women undergoing primary prolapse surgery because of single compartment vaginal prolapse stage 2 or more (ICS classification).

Main study parameters/endpoints:
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 outcomes: pelvic floor function measured using the UDI-6, IIQ-7 and PISQ-12 questionnaires before and 6 months after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
- Main changes (audit trail)
- RECORD2-aug-2012 - 13-aug-2012


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