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Use of acellular sling graft for Stress Urinary Incontinence

Investigating effectiveness of using tissue engineered skin instead of mesh in pubovaginal tape procedure in stress urinary incontinence

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201611278554N3
Enrollment
20
Registered
2017-05-28
Start date
2016-12-08
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Stress Uinary Incontinence. Stress incontinence

Interventions

Intervention 1: placement of de-cellularaized Sling tape using the classical pubovaginal sling anti incontinence procedure. Intervention 2: classical pubovaginal anti in?ontinence female procedure wit
Treatment - Surgery
placement of de-cellularaized Sling tape using the classical pubovaginal sling anti incontinence procedure
classical pubovaginal anti in?ontinence female procedure with use of synthetic mesh

Sponsors

Tehran University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 51 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Urinary 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

MeasureTime frame
Post-operative side effects. Timepoint: 12 months after surgery. Method of measurement: history taking and physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammadjavad mohseni

Pediatric Urology and regenerative medcine Research Center, Tehran university of medical sciences

mjmohseni.purc@gmail.com+98 21 6656 5400

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026