Stress Urinary Incontinence, Urinary Retention After Procedure, Urinary Retention Postoperative
Conditions
Keywords
Stress urinary incontinence, Pubovaginal sling, Urinary retention
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).
Interventions
PROCEDURESling 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)
PROCEDURESling 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
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old and no improvement with conservative management
Exclusion criteria
* Prior anti incontinence surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling | 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups. | 1 month | Cure will be considered the answer NO to the 3rd question of Urogenital Distress Inventory and a negative cough test. |
Countries
Brazil
Contacts
Primary ContactAline Silva, MD
Outcome results
None listed