Trials / Unknown
UnknownNCT04465578
Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Hospital de Clinicas de Porto Alegre · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
| PROCEDURE | 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 |
Timeline
- Start date
- 2020-02-10
- Primary completion
- 2020-11-30
- Completion
- 2020-11-30
- First posted
- 2020-07-10
- Last updated
- 2020-07-10
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04465578. Inclusion in this directory is not an endorsement.