This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Hospital de Mataró
Barcelona, Spain
Hospital de Viladecans
Barcelona, Spain
Hospital General de Granollers
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Effectiveness
Percentage of patients who are regarded as cured or improved one-year after surgery with both techniques based on the following criteria: * CURED: negative cough stress test and patient must be fully satisfied with the operation (no leaks, no voiding dysfunction, and no use of urinary protection); Patient Global Impresison of Improvement (PGI-I) scale must be "Very much better". * IMPROVED: cough stress test had to be negative and the patient moderately satisfied with the result of surgery due to an increase in urinary frequency and/or sporadic urgency episodes; PGI-I must be "Much better" or "A little better".
Time frame: One year
Number of participants with adverse events
Comparison of the intra- and postoperative complications between both procedures.
Time frame: Up to one year.
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Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Santa Caterina
Girona, Spain
Hospital General Riotinto
Huelva, Spain
Hospital Quiron Sagrado Corazon
Seville, Spain
Hospital Virgen del Rocío
Seville, Spain