Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.

Not Applicable

• Conditions: Urinary Retention After Procedure; Stress Urinary Incontinence; Urinary Retention Postoperative
• Interventions: Procedure: Sling tension adjustment by classic technique; Procedure: Sling tension adjustment by height of 4 cm

• Registration Number: NCT04465578
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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 Timeline

• Study Start: 2020-02-10
• Status Verified: 2020-07
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• 18 years old and no improvement with conservative management

Exclusion Criteria

• Prior anti incontinence surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sling tension adjustment by classic technique	Sling tension adjustment by classic technique	We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)
Sling tension adjustment by height of 4 cm	Sling tension adjustment by height of 4 cm	We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm

Primary Outcome Measures

Name	Time	Method
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling	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 Outcome Measures

Name	Time	Method
To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.	1 month	Cure will be considered the answer "NO" to the 3rd question of Urogenital Distress Inventory and a negative cough test.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil