Vestibulodynia
Conditions
Brief summary
The investigators would like to investigate if lipofilling with its adipose derived stem cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than vestibulectomy. The investigators expect the study to be successful because of the anti-inflammatory effects of the ADSC and its effectiveness -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia or post mastectomy pain syndrome. Method: A controlled intervention study: one group receiving golden standard therapy 'vestibulectomy' and one group receiving vestibular lipofilling.
Interventions
PROCEDUREAdipose derived stem cell transplantation via lipofilling
Liposuction of 60cc abdominal fat with its adipose derived stem cells which will be reinjected (10-20 cc) in the vestibular area after centrifugation for 3 minutes at 1000 rpm and decantation of oil and red blood cells.
PROCEDURESurgical excision
Excision of painful areas
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
However, subjects in the lipofilling group will be able to undergo surgery (excision) 3 months after the lipofilling of this intervention did not have the requested effect.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Vestibulodynia requesting surgery
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Q-tip scores (Cotton swab assessment of vaginal pain) 3 months after surgery | 3 months after surgery | Very light pressure along specific points in the area of the vulvar vestibule and where there is tenderness, asking the patient to characterize the tenderness on a scale of 0-10, whether it's no pain or exquisite pain and then plotting that on a diagram. Most physicians will find that in women with vestibulitis, the tenderness is most pronounced just below the hymenal margin and around the orifices of the so-called Bartholin gland ducts. |
Countries
Belgium
Outcome results
None listed