Lipofilling as a Treatment for Vestibulodynia
- Conditions
- Vestibulodynia
- Registration Number
- NCT03431779
- Lead Sponsor
- University Hospital, Ghent
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9
- Vestibulodynia requesting surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ghent University Hospital
🇧🇪Ghent, Belgium
Ghent University Hospital🇧🇪Ghent, Belgium