Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT02334878|
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress||Biological: Stem Cells,Mesenchymal Procedure: surgery (TVT)||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Bone Marrow-derived Mesenchymal Stem Cells Versus Tension-free Vaginal Tape for Treatment of Female Stress Urinary Incontinence: An Open-label Clinical Trial|
|Actual Study Start Date :||October 1, 2015|
|Actual Primary Completion Date :||October 30, 2016|
|Actual Study Completion Date :||December 1, 2016|
Experimental: Stem cells,Mesenchymal
Periurethral injection of autologous bone-marrow derived stem cells.
Biological: Stem Cells,Mesenchymal
The patient will be placed in lithotomy position. A Foley's catheter (size 18) will be inserted in the urethra, then under local anaesthesia; retrieved cells (total 20- 30 million cells per patient in 10cc syringe) will be injected into the submucosal tissue at the level of the proximal urethra just distal to the bladder neck (guided by stretch on the Foley's catheter), at 3,9,12 o'clock, injecting around 3.5 cc in each site.
Active Comparator: surgery (TVT)
Tension-free vaginal tape operation: a midurethral sling operation
Procedure: surgery (TVT)
A small midurethral incision will be made in the vaginal mucosa, then a polypropylene 40*1cm mesh tape attached to two curved trocars will be passed lateral to the urethra & through the endopelvic fascia into the retropubic space. The trocar will then be passed along the back of the pubic bone, through the rectus fascia, in two small suprapubic skin incisions, then the tension on the tape adjusted & the remaining tape cut off at the level of the skin.
- change in cough test & urodynamic study as a measure of efficacy of treatment [ Time Frame: before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection). ]cough test: as positive or negative leakage with cough. Urodynamic study: changes in abdominal leak point pressure, and changes in maximum urethral closure pressure
- Quality of life as measured by the Incontinence Quality of Life (I-QOL) Instrument Score [ Time Frame: before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection). ]
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): NCT02334878
|Maternity hospital, Ain Shams University|
|Study Chair:||Mohamed A El-Nazer, PhD||Ain Shams University Maternity Hospital|
|Study Director:||Abdel-Latif G El-Kholy, PhD||Ain Shams University Maternity Hospital|
|Study Director:||Mostafa F Gomaa, PhD||Ain Shams University Maternity Hospital|