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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

January 25, 2018
February 13, 2018
May 3, 2018
May 2018
December 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03431779 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Lipofilling as a Treatment for Vestibulodynia
Adipose Derived Stem Cell Transplantation Via Lipofilling for Vestibulodynia: a Controlled Intervention Study

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.

Not Provided
Interventional
Not Applicable
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
Vestibulodynia
  • 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.
  • Procedure: Surgical excision
    Excision of painful areas
  • 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.
    Intervention: Procedure: Adipose derived stem cell transplantation via lipofilling
  • Active Comparator: Surgical excision
    Excision of painful areas
    Intervention: Procedure: Surgical excision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
August 2020
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Vestibulodynia requesting surgery

Exclusion Criteria:

Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only female subjects can be included.
18 Years to 85 Years   (Adult, Older Adult)
No
Contact: Bernard Depypere +32 9 332 57 30 bernard.depyere@ugent.be
Belgium
 
 
NCT03431779
B670201734071
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Not Provided
University Hospital, Ghent
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP