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

NCT04465578 | Unknown

• 1 other identifier: 2020-0001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Urinary Retention Postoperative; Urinary Retention After Procedure

Keywords

Stress urinary incontinence; Pubovaginal sling; Urinary retention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.

  1 month

Study Arms (2)

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)

Procedure: Sling tension adjustment by classic technique

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

Procedure: Sling tension adjustment by height of 4 cm

Interventions

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)

Sling tension adjustment by classic technique

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

Sling tension adjustment by height of 4 cm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and no improvement with conservative management

You may not qualify if:

• Prior anti incontinence surgery

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Retention

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiago Rosito, Doctor

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aline Silva, MD

CONTACT

+5551991911801; aline.urologia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: February 10, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)