Lipofilling as a Treatment for Vestibulodynia

Not Applicable

Completed

• Conditions: Vestibulodynia
• Interventions: Procedure: Surgical excision; Procedure: Adipose derived stem cell transplantation via lipofilling

• 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

Study Timeline

• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-13
• Study Start: 2018-04-17
• Primary Completion: 2021-05-14
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

• Vestibulodynia requesting surgery

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical excision	Surgical excision	Excision of painful areas
Adipose derived stem cell transplantation via lipofilling	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.

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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium