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Lipofilling as a Treatment for Vestibulodynia

Primary Purpose

Vestibulodynia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Adipose derived stem cell transplantation via lipofilling
Surgical excision
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibulodynia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Vestibulodynia requesting surgery

Exclusion Criteria:

-

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adipose derived stem cell transplantation via lipofilling

Surgical excision

Arm 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.

Excision of painful areas

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2018
Last Updated
July 14, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03431779
Brief Title
Lipofilling as a Treatment for Vestibulodynia
Official Title
Adipose Derived Stem Cell Transplantation Via Lipofilling for Vestibulodynia: a Controlled Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibulodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adipose derived stem cell transplantation via lipofilling
Arm Type
Experimental
Arm 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.
Arm Title
Surgical excision
Arm Type
Active Comparator
Arm Description
Excision of painful areas
Intervention Type
Procedure
Intervention Name(s)
Adipose derived stem cell transplantation via lipofilling
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Surgical excision
Intervention Description
Excision of painful areas
Primary Outcome Measure Information:
Title
Q-tip scores (Cotton swab assessment of vaginal pain) 3 months after surgery
Description
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.
Time Frame
3 months after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female subjects can be included.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vestibulodynia requesting surgery Exclusion Criteria: -
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lipofilling as a Treatment for Vestibulodynia

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