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

Study Overview
=================
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).

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and no improvement with conservative management Exclusion Criteria: Prior anti incontinence surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sling tension adjustment by classic technique<br>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<br>* We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)<br>|
| Active Comparator: Sling tension adjustment by height of 4 cm<br>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<br>* We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress urinary incontinence, Pubovaginal sling, Urinary retention