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The aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the distance between the fixation knot and the aponeurosis of 4 cm.
A randomized double-blind clinical trial will be conducted in women over 18 years of age with stress urinary incontinence and indication for surgical treatment, who have not undergone previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of urinary retention and the rate of cure after the procedure will be evaluated. The incidence of urinary retention in 1 month postoperatively will be evaluated in the two different techniques (post-voiding residue \> 200ml or the need for intermittent bladder catheterization) and the cure rate for urinary incontinence (cough test and response "No" to the question 3 of the Urogenital Distress Inventory questionnaire).
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Start Date
February 10, 2020
Primary Completion Date
November 30, 2020
Completion Date
November 30, 2020
Last Updated
July 10, 2020
56
ESTIMATED participants
Sling tension adjustment by classic technique
PROCEDURE
Sling tension adjustment by height of 4 cm
PROCEDURE
Lead Sponsor
Hospital de Clinicas de Porto Alegre
NCT04597372
NCT07174349
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06706362