Lipofilling as a Treatment for Vestibulodynia

Ghent University Hospital (UZ)

Status: Completed

Conditions: Vestibulodynia

Treatments: Procedure: Surgical excision; Procedure: Adipose derived stem cell transplantation via lipofilling

Study type: Interventional

Funder types: Other

Identifiers

NCT03431779

BC-01060

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vestibulodynia requesting surgery

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Adipose derived stem cell transplantation via lipofilling

Experimental group

Description:

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.

Treatment:

Procedure: Adipose derived stem cell transplantation via lipofilling

Surgical excision

Active Comparator group

Description:

Excision of painful areas

Treatment:

Procedure: Surgical excision