|
Recommendations and Research Priorities from the Vulvodynia
Workshop
(from Workshop Proceedings, published by the ORWH)
April 2-3, 1997
Lister Hill Auditorium, NIH
Bethesda, Maryland
Role of the ISSVD
- Refine the definition of vulvodynia
- time point for chronicity
- inclusion/exclusion criteria
- include a physical finding in definition
- Dissemination of definition
- Coordination of clinical trials
Multicenter Therapeutic Trials – I
- START!
- Need for coordinating center for access to patients
- Clinical trials group should:
- develop diagnostic criteria
- define subsets (e.g., psychological impairment)
- develop tools for measuring endpoints – pain, function,
psychological measures, quality of life measures
Multicenter Therapeutic Trials – II
- Intralesional IFN-a, capsaicin, topical anesthetics, low-oxalate
diet
- Undertake trials using multi-disciplinary approach with three
elements:
- low-dose tricyclics vs Flexoril
- aerobic exercise
- cognitive behavioral therapy
Pelvic Floor
- Develop, validate, standardize methods for evaluation of pelvic
floor
functions – establish normals
- Characterize abnormal pelvic floor activity in patients with
vulvar pain
- Evaluate the effect of treatment on vulvar pain and pelvic floor
functions
Epidemiology
- Conduct case-controlled or population studies
- Use existing data collection instruments and develop new vulvodynia-
specific questions as needed
- Identify group at high risk – will allow prospective studies
- Seek influence of psychosocial correlates (depression, anxiety,
trauma,
child abuse)
- Look into current models used by other pain groups
Surgical Therapy
- Conduct a retrospective, multicenter analysis of pooled surgical
cases
- Set up a prospective, randomized multicenter study
- Define population – stratify pain/functional levels
- Define surgical procedure(s)
- Define endpoints
- Develop audiovisual teaching aids – set up a working group
Clinical Studies
- Well-defined population – set up rigorous inclusion/exclusion
criteria
- Well-controlled – (placebo, randomized, double-blind, cross-over,
case-
controlled)
- Standardized clinical rating scales – "measure development"
for use
across multiple treatment studies
- Define endpoints
- Integrate psycho-sexual history
Infections
- Examine role of HSV and HPV with modern methods
- Evaluate role or past-present YEAST infection
- Define vaginal microflora – correlate with cytokines
*Women to be enrolled in vulvodynia studies should:
- be free from other infections
(BV, GC, chlamydia, trichomonas, HSV, candida)
- not have had any antibiotics in previous two weeks
Pain Research
- Develop animal model for neuropathic conditions of the pelvic
floor
- Using animal models, evaluate the sensory and motor pathways
and
central neural control of pelvic floor
- Look for evidence of sympathetic involvement
- afferent nerve sensitivity involvement
- tilt tables
- use agonists/antagonists
- Look for evidence of central sensitization – exquisite
sensory testing in the
vulva
|
