An interventional study of Adipose derived stem cell transplantation via lipofilling and Surgical excision in Vestibulodynia, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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.
117 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's enrollment of 9 is below the median of 46 across 89 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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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
Excision of painful areas
Procedure: Surgical excision
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
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.
Time frame: 3 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in May 2021, 36 months.
Of 32 non-industry interventional studies with no phase under Vulvodynia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's 36 months is close to that.
Counting every sponsor, half of 32 studies reached it within 36 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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