Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years old and no improvement with conservative management
Exclusion Criteria
- •Prior anti incontinence surgery
Outcomes
Primary Outcomes
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
Time Frame: 1 month
Urinary retention will be considered the need for bladder catheterization or post-voiding residue\> 200ml after 1 month), in patients with tension adjustment by the classic technique x node height to the abdominal rectus fascia of 4cm.
Secondary Outcomes
- To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.(1 month)