Adipose Derived Stem Cell Transplantation Via Lipofilling for Vestibulodynia: a Controlled Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vestibulodynia
- Sponsor
- University Hospital, Ghent
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Q-tip scores (Cotton swab assessment of vaginal pain) 3 months after surgery
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Vestibulodynia requesting surgery
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Q-tip scores (Cotton swab assessment of vaginal pain) 3 months after surgery
Time Frame: 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.