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Lipofilling as a Treatment for Vestibulodynia

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ClinicalTrials.gov Identifier: NCT03431779
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Vestibulodynia Procedure: Adipose derived stem cell transplantation via lipofilling Procedure: Surgical excision Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose Derived Stem Cell Transplantation Via Lipofilling for Vestibulodynia: a Controlled Intervention Study
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: Surgical excision
Excision of painful areas
Procedure: Surgical excision
Excision of painful areas




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female subjects can be included.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vestibulodynia requesting surgery

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431779


Contacts
Contact: Bernard Depypere +32 9 332 57 30 bernard.depyere@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Bernard Depypere    +32 9 332 57 30    bernard.deypere@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03431779     History of Changes
Other Study ID Numbers: B670201734071
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis