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Comparison of surgery and stem cell therapy in the treatment of women’s urinary incontinence

Clinical trial of comparison of medium-term results of single incision mini-sling and stem cell therapy in the treatment of women’s stress urinary incontinence

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190517043609N2
Enrollment
30
Registered
2020-05-03
Start date
2016-10-10
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary incontinence. Stress incontinence (female) (male)

Interventions

Intervention 1: intervention group: In the stem cell injection group: After obtaining written consent, the mucosal tissue sample is separated from the volunteer patients by the physician and placed in

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahbube Mirzaie

Kerman University of Medical Sciences

mirzaeimahboubeh@yahoo.com+98 34 3132 5700

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026