Lipofilling as a Treatment for Vestibulodynia

NCT03431779 | Completed

• 1 other identifier: BC-01060
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibulodynia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Adipose derived stem cell transplantation via lipofilling

EXPERIMENTAL

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.

Procedure: Adipose derived stem cell transplantation via lipofilling

Surgical excision

ACTIVE COMPARATOR

Excision of painful areas

Procedure: Surgical excision

Interventions

Adipose derived stem cell transplantation via lipofilling PROCEDURE

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.

Adipose derived stem cell transplantation via lipofilling

Surgical excision PROCEDURE

Excision of painful areas

Surgical excision

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Only female subjects can be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vestibulodynia requesting surgery

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: However, subjects in the lipofilling group will be able to undergo surgery (excision) 3 months after the lipofilling of this intervention did not have the requested effect.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 13, 2018
• Study Start: April 17, 2018
• Primary Completion: May 14, 2021
• Study Completion: May 31, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)