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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465578
• Other study ID #: 2020-0001
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Aline Silva, MD
• Phone: +5551991911801
• Email: aline.urologia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and no improvement with conservative management

Exclusion Criteria:

• Prior anti incontinence surgery

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Retention
• Urinary Retention After Procedure
• Urinary Retention Postoperative

Intervention

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)
• 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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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