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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2020

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).

Interventions

  • Procedure: 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)
  • Procedure: 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

Arms, Groups and Cohorts

  • Active Comparator: 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)
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years old and no improvement with conservative management Exclusion Criteria:

  • Prior anti incontinence surgery

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital de Clinicas de Porto Alegre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tiago Rosito, Doctor, Principal Investigator, Hospital de Clinicas de Porto Alegre
  • Overall Contact(s)
    • Aline Silva, MD, +5551991911801, aline.urologia@gmail.com

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