Comparison of surgery and stem cell therapy in the treatment of women’s urinary incontinence
- Conditions
- Stress Urinary incontinence.Stress incontinence (female) (male)N39.3
- Registration Number
- IRCT20190517043609N2
- Lead Sponsor
- Kerman University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 30
Women at least 18 years old
history of SUI (Stress Urinary Incontinence)
Failure to respond to conservative managements after 3 months
Urine leak in the initial examination during coughing or Valsalva maneuver
persistent urinary tract infection (UTI)
proved Vesicouretral Reflux (VUR)
History of previous Stress urinary incontinence surgery
history of neurological diseases such as Cerebro Vascular Accident(CVA) ,muscular dystrophy or Multiple Sclerosis(MS)
Obesity (Body Mass Index(BMI)> 40)
Localized fibrosis and stiffness at the injection site in the cystoscopy
high grade cystocele and rectocele (equal to or more than 3 according to the pelvic organ prolapse quantification system (POP-Q)
Overactive bladder symptoms (Uninhibited contractions, low capacity, low compliance in urodynamic study)
Medium to severe bladder trabeculation and or open bladder neck in cystourethroscopy
Residue of urine > 100cc and or maximum flow rates of lower than 15 ml/s
Pregnant or intending future pregnancies
coagulation disorders
history of Bulking agent injection in urethra
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Examination of stress urinary. Timepoint: 1, 3, 6 and 12 months after the intervention ( surgery or stem cell injection). Method of measurement: International Urinary Incontinence Questionnaire(IIQ score).
- Secondary Outcome Measures
Name Time Method