Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence
|ClinicalTrials.gov Identifier: NCT01355133|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Biological: Transurethral intrasphincteric autologous myoblast implantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transurethral Ultrasound-directed Injection of Autologous Myoblasts in Combination With Functional Electrical Stimulation in Patients With Intrinsic Urinary Sphincter Deficiency|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Biological: Transurethral intrasphincteric autologous myoblast implantation
- Change from baseline in Incontinence episode frequency (IEF) [ Time Frame: 6 months post-implantation ]The median percent change from baseline in IEF using the 3-day bladder diary analysis
- Change from baseline in Quality of Life (I-QOL) total score [ Time Frame: 6 months post-implantation ]Mean improvement from baseline for the Incontinence Quality of Life (I-QOL) total score
- Change from baseline in the Incontinence score [ Time Frame: 6 months post-implantation ]
- Time to onset of response [ Time Frame: Up to 6 months post-implantation (based on recordings at baseline, at implantation, at 6 weeks, 3 months and 6 months post-impalntation) ]Time to onset of response; time to maximum response; maintenance of response observed through changes in Incontinence episode frequency(IEF), Visual analog scale of the degree of suffering (VAS), Modified patient global impression of improvement(PGI-I*), fixed bladder stress test and I-QOL.
- Change from baseline in Fixed bladder stress test outcome [ Time Frame: Baseline, 6 months postimplantation. ]
- Rate for subsequent incontinence surgery [ Time Frame: 6 months post-implantation ]
- Change from baseline in Urodynamic evaluation [ Time Frame: 6 months post-implantation ]Cystometry, urethral pressure profile (UPP), 1-hour pad-test.
- Safety [ Time Frame: Up to 6 months post-implantation ]
Number of adverse events, patholgical lab values, vital signs and weight recordings. Number of immediate and delayed complications of cell injection, including surgical injury, scars, urinary tract infection, inflammation, pelvic pain, prolonged urinary retention, voiding dysfunction, de novo urge incontinence, hematuria, hyperplasia or tumours.
Any clinically significant findings based on physical examination, standard haematology, clinical chemistry and urinalysis profiles, Electrocardiogram (ECG), Blood Pressure (BP), pulse rate and adverse events recordings.
- Change from baseline in Urinary incontinence semiquantitative (UIS) [ Time Frame: 6 months post-implantation ]Amount of leaked urine measured semiqantitative from a 3-day bladder diary.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355133
|University Medical Center Ljubljana, Dept. of Gynecology|
|Ljubljana, Slovenia, 1000|