A Phase 4 interventional study of PVDF transobturator tape and Polypropylene transobturator tape in Urinary Stress Incontinence, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 9 sites in Spain. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 4, Interventional, and Treatment
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.
658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.
This study's enrollment of 286 is above the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transobturator tension-free suburethral tape made of polyvinylidene fluoride.
Device: PVDF transobturator tape
Transobturator tension-free suburethral tape made of polypropylene.
Device: Polypropylene transobturator tape
Also known as: Dynamesh-SIS
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.
Change in subjective questionnaires of incontinence severity
Change in the punctuation of the following questionnaires comparing before surgery and one year after operation: * International consultation on Incontinence Urinary Questionnaire-Short Form (ICIQ-SF). * Sandvik severity index.
Time frame: One year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute