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se of acellular sling graft for Stress Urinary Incontinence

Phase 2
Recruiting
Conditions
Stress Uinary Incontinence.
Stress incontinence
Registration Number
IRCT201611278554N3
Lead Sponsor
Tehran University Of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
20
Inclusion Criteria

Inclusion criterion: Women in the range of 30 to 50 years of age with complaint of urine leakage on exertion, effort, sneezing or coughing that urodynamic showed severe SUI type3(Abdominal Leak Point Pressure (ALPP)<60 cmH2O)
Exclusion criteria: Any patient with pelvic organ prolapse (POP) greater than stage 2 according to POP-Q classification; secondary cause of SUI; overactive bladder that in urodynamic study was counted as unsuitable; history of previous anti-incontinence procedure; history of smoking; history of pelvic radiation; any clue of high post voiding residue (PVR)

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
rinary incontinency. Timepoint: before and 12 months after surgery. Method of measurement: ICQ questionnaire.;Abdominal leak point pressure. Timepoint: before and 12 months after operation. Method of measurement: urodynamic study.
Secondary Outcome Measures
NameTimeMethod
Post-operative side effects. Timepoint: 12 months after surgery. Method of measurement: history taking and physical examination.
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