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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sling tension adjustment by classic technique | Active Comparator | 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 | Active Comparator | We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sling tension adjustment by classic technique | Procedure | We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aline Silva, MD | Contact | +5551991911801 | aline.urologia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tiago Rosito, Doctor | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| Sling tension adjustment by height of 4 cm | Procedure | We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm |
|
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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