Lipofilling as a Treatment for Vestibulodynia

Vestibulodynia Clinical Trial

Official title:

Adipose Derived Stem Cell Transplantation Via Lipofilling for Vestibulodynia: a Controlled Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431779
• Other study ID #: BC-01060
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 31, 2023
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Vestibulodynia requesting surgery Exclusion Criteria: -

Related Conditions & MeSH terms

• Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Procedure:
• Adipose 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.
• Surgical excision
Excision of painful areas

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Q-tip scores (Cotton swab assessment of vaginal pain) 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.	3 months after surgery