Stress Urinary Incontinence Clinical Trial
Official title:
Effectiveness and Safety of Cell-Assisted Lipotransfer for the Treatment of Stress Urinary Incontinence Via Endoscopically-Assisted Administration of Fat Tissue Micrografts Enriched by Autologous Adipose-Derived Regenerative Cells
Autologous washed and homogenized fat micrograft harvested from the patient's front abdominal wall enriched with adipose-derived regenerative cells (ADRC) derived by enzyme-treatment of a portion of the harvested fat. Fat tissue micrograft mixed with ADRC will be administered one-time endoscopically into submucosal layer of urethra under eye control. This is a single arm study with no control. All patients receive cell therapy.
Fat tissue obtainment. Subjects will undergo liposuction under local anesthesia. In this
procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline
infused into the adipose compartment to minimize blood loss and contamination of the tissue
by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced
into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe
and under gentle suction moved through the adipose compartment, mechanically disrupting the
fat tissue. Aspirate volume - approximately 150 cc. Procedure time - 30 minutes.
ADRC isolation. Aspirated fat tissue placed into sterile tubes with transport medium and
delivered into the laboratory within 15 minutes. To isolate the ADRC, part of lipoaspirate
(approximately 100 cc) washed extensively with equal volumes of phosphate-buffered saline
and digested with collagenase. After enzyme activity neutralization decomposed fat tissue
eliminated and ADRC washed 3 times with saline. Cells divided into 3 portions. First portion
used for counting, viability and sterility assessment. Second portion prepared for freezing
in liquid nitrogen. Third portion mixed with fat micrograft.
Fat tissue enriched micrograft preparation. Obtained fat tissue (approximately 20-30 cc)
washed repeatedly. Aspirated fat settled down in syringes placed in vertical position, after
that liquid fraction eliminated. Syringes with fat filled up with Ringer's solution and
procedure of settlement repeated 3-5 times. Washed fat placed on metallic mesh and mashed up
using metallic spatula. Homogenized fat mixed with prepared ADRC and collected in syringe
for further injection. Ratio fat micrograft/fat for ADRC estimated according to aspirate
volume and usually forms 1:10. For example, ADRC obtained from 100 cc of fat tissue should
be mixed with 10 cc of fat micrograft.
Fat micrograft preparation is also possible in Puregraft System (Cytori Therapeutics Inc) -
closed disposable system for fat tissue selective washing.
Periurethral injection of fat micrograft enriched with ADRC Urethra punctured several times
circle-wise at the bulbomembranous region at a depth of 5 mm under endoscopic vision and
0.5-1 mL of fat micrograft enriched with ADRC injected each time. Total volume of solution
injected - approximately 8 mL. After fat micrograft injected, urethral balloon catheter
placed and removed the following day.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04829357 -
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
|
||
Completed |
NCT05493735 -
Lidocaine for Pessary Check Pain Reduction
|
Phase 3 | |
Completed |
NCT04512053 -
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
|
Phase 2 | |
Active, not recruiting |
NCT06224335 -
Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
|
||
Recruiting |
NCT05304312 -
The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women
|
N/A | |
Not yet recruiting |
NCT05527665 -
Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
|
||
Not yet recruiting |
NCT04558762 -
Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
|
||
Withdrawn |
NCT02524366 -
A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement
|
N/A | |
Completed |
NCT01924728 -
Efficacy of Magnetic Stimulation for Stress Urinary Incontinence
|
N/A | |
Completed |
NCT01676662 -
Solace European Confirmatory Trial
|
N/A | |
Unknown status |
NCT01455779 -
Lyrette: Renewing Continence Objective and Subjective Efficacy Study
|
N/A | |
Terminated |
NCT01029106 -
Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)
|
N/A | |
Completed |
NCT01123096 -
Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?
|
N/A | |
Completed |
NCT01770691 -
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
|
N/A | |
Withdrawn |
NCT00573703 -
Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence
|
Phase 4 | |
Completed |
NCT00234754 -
Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women
|
N/A | |
Completed |
NCT00441454 -
Retropubic vs. Transobturator Tension-free Vaginal Tape
|
N/A | |
Completed |
NCT03985345 -
Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.
|
N/A | |
Active, not recruiting |
NCT03671694 -
Laser Vaginal Treatment for SUI
|
N/A | |
Completed |
NCT04097288 -
Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects
|
Phase 1 |