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

Primary Purpose

Stress Urinary Incontinence, Urinary Retention Postoperative, Urinary Retention After Procedure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sling tension adjustment by classic technique
Sling tension adjustment by height of 4 cm
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stress Urinary Incontinence focused on measuring Stress urinary incontinence, Pubovaginal sling, Urinary retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years old and no improvement with conservative management

Exclusion Criteria:

  • Prior anti incontinence surgery

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sling tension adjustment by classic technique

Sling tension adjustment by height of 4 cm

Arm Description

We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 7, 2020
Last Updated
July 7, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04465578
Brief Title
Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
Official Title
Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Urinary Retention Postoperative, Urinary Retention After Procedure
Keywords
Stress urinary incontinence, Pubovaginal sling, Urinary retention

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sling tension adjustment by classic technique
Arm Type
Active Comparator
Arm Description
We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)
Arm Title
Sling tension adjustment by height of 4 cm
Arm Type
Active Comparator
Arm Description
We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm
Intervention Type
Procedure
Intervention Name(s)
Sling tension adjustment by classic technique
Intervention Description
We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)
Intervention Type
Procedure
Intervention Name(s)
Sling tension adjustment by height of 4 cm
Intervention Description
We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm
Primary Outcome Measure Information:
Title
To evaluate the incidence of urinary retention in short-term after fascial pubovaginal sling
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
To evaluate the incidence of curing stress urinary incontinence in short-term after fascial pubovaginal sling in both groups.
Description
Cure will be considered the answer "NO" to the 3rd question of Urogenital Distress Inventory and a negative cough test.
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old and no improvement with conservative management Exclusion Criteria: Prior anti incontinence surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Silva, MD
Phone
+5551991911801
Email
aline.urologia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiago Rosito, Doctor
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline Silva, MD
Phone
+555133598286
Email
aline.urologia@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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