Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00744198
• Date of registration: 26/08/2008
• Prospective Registration: Yes
• Primary sponsor: University Magna Graecia
• Public title: Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence
• Scientific title: A Comparison in Terms of Efficacy and Safety Among Three Different Materials for Trans-obturator Correction of Urinary Stress Incontinence: Autologous, Synthetic and Biological Sling
• Date of first enrolment: August 2012
• Target sample size: 8
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00744198
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Fulvio Zullo, MD
• Affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

• Name: Stefano Palomba, MD
• Affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

• Name: Ingrid Tomaino, MD

• Name: Stefano Palomba, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Genuine stress urinary incontinence by self report, examination and test

- Urethral hypermobility

- Eligible for all three surgical procedures

- Ambulatory

Exclusion Criteria:

- Pregnancy

- <12 months post-partum

- Systemic disease and/or drugs known to affect bladder function

- Current chemotherapy or radiation therapy

- Urethral diverticulum, augmentation cytoplasty, or artificial sphincter

- Recent pelvic surgery

- Severe genuine stress incontinence (loss of urine with minimal physical activity)
with associated prolapse equal to or more than second degree

- Previous pelvic or anti-incontinence surgery

- History of severe abdominopelvic infections

- Known extensive abdominopelvic adhesions

- Detrusor instability and/or intrinsic sphincter dysfunction

- Other gynaecologic pathologies (eg, fibroids, ovarian cysts)

- BMI >30



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Stress Urinary Incontinence

Intervention(s)

Procedure: Autologous transobturator tape procedure

Procedure: Biological transobturator tape procedure

Procedure: Synthetic transobturator tape procedure

Primary Outcome(s)

Cure rate [Time Frame: 12 months]

Secondary Outcome(s)

Recurrence rate [Time Frame: 12 months]

Sexual function [Time Frame: 12 months]

Failure rate [Time Frame: 12 months]

Quality of life [Time Frame: 12 months]

Intra-operative complication rate [Time Frame: one day]

Postoperative complications rate [Time Frame: 12 months]

Secondary ID(s)

02/2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors