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

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 Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence; Urinary Retention Postoperative; Urinary Retention After Procedure
• Intervention / Treatment: Procedure: Sling tension adjustment by classic technique; Procedure: Sling tension adjustment by height 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 Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: Aline Silva, MD; Phone Number: +555133598286; Email: aline.urologia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18 years old and no improvement with conservative management

Exclusion Criteria:

• Prior anti incontinence surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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)
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling	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.	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Tiago Rosito, Doctor, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Stress urinary incontinence; Urinary retention; Pubovaginal sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Retention
• Other Study ID Numbers: 2020-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No