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

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Urinary Retention Postoperative; Stress Urinary Incontinence; Urinary Retention After Procedure

Treatments: Procedure: Sling tension adjustment by classic technique; Procedure: Sling tension adjustment by height of 4 cm

Study type: Interventional

Funder types: Other

Identifiers

NCT04465578

2020-0001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 56 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old and no improvement with conservative management

Exclusion criteria

• Prior anti incontinence surgery

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Sling tension adjustment by classic technique

Active Comparator group

Description:

We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)

Treatment:

Procedure: Sling tension adjustment by classic technique

Sling tension adjustment by height of 4 cm

Active Comparator group

Description:

We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm

Treatment:

Procedure: Sling tension adjustment by height of 4 cm