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

NCT ID: NCT04465578

Last Updated: 2020-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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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

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Stress Urinary Incontinence Urinary Retention Postoperative Urinary Retention After Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Sling tension adjustment by classic technique

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Sling tension adjustment by height of 4 cm

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years old and no improvement with conservative management

Exclusion Criteria

* Prior anti incontinence surgery
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiago Rosito, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Aline Silva, MD

Role: CONTACT

+5551991911801

Facility Contacts

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Aline Silva, MD

Role: primary

+555133598286

Other Identifiers

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2020-0001

Identifier Type: -

Identifier Source: org_study_id

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