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Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

Primary Purpose

Injury Due to Sling-shot

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Ophira

Transobturator sling

About this trial

This is an interventional treatment trial for Injury Due to Sling-shot focused on measuring stress incontinence, transobturator sling, single-incision mini-sling

Eligibility Criteria

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

Inclusion Criteria:

Patients aged over 18 years
Clinical and urodynamic diagnosis of stress urinary incontinence
Absence of associated neurological diseases
No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)

Exclusion Criteria:

urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction
Coagulopathies
Pregnancy
History of sensitivity to foreign body
Acute Urinary Tract Infection
Sequelae of high exposure to ionizing radiation
Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting
anesthetic contraindication to the procedure
Vulvovaginitis: presence of vaginal discharge with laboratory proven infection

Sites / Locations

Faculty of Medicine of ABC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single incision mini-sling

Transobturator sling

Arm Description

Experimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt®

Control group: surgery to treat stress urinary incontinence with the Unitape T Plus®.

Outcomes

Primary Outcome Measures

Comparison of the cure rates between the mini sling and classical transobturator tapes

Percentage of patients who are regarded as cured or improved based on the following criteria: Negative Cough Stress test 1 year after surgery Pad Test < 2 g 1 year after surgery

Secondary Outcome Measures

Number of participants with adverse events

Comparison of the intra- and postoperative complications between procedures

Full Information

NCT ID

NCT02540525

First Posted

February 22, 2014

Last Updated

September 1, 2015

Sponsor

Faculdade de Medicina do ABC

1. Study Identification

Unique Protocol Identification Number

NCT02540525

Brief Title

Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

Official Title

Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Faculdade de Medicina do ABC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

OBJECTIVE: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment. METHODS: This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Injury Due to Sling-shot

Keywords

stress incontinence, transobturator sling, single-incision mini-sling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single incision mini-sling

Arm Type

Experimental

Arm Description

Experimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt®

Arm Title

Transobturator sling

Arm Type

Active Comparator

Arm Description

Control group: surgery to treat stress urinary incontinence with the Unitape T Plus®.

Intervention Type

Device

Intervention Name(s)

Ophira

Intervention Description

The procedure will be perfomed with a single incision in anterior wall vagina

Intervention Type

Device

Intervention Name(s)

Transobturator sling

Other Intervention Name(s)

Unitape T plus

Intervention Description

Safyre T Plus ® system uses two helical needles for securing an average urethral sling mesh polypropylene soft tissue below the pubic bone by means of spinal anesthesia. Short form of the sling implantation is carried out as follows: a small longitudinal incision in the anterior vaginal wall approximately 2 cm is performed at 1 cm from the urethral meatus. Takes place below minimum dissection toward the lower branch of the ischium, and with the aid of the needle obturator and perforated membrane (outside-in maneuver). After that, the sling is attached to the needle carrying the same path. Subsequently, the passage of the needle is held in contraleral side. The procedure finishes performing the adjustment of the track with the aid of Kelly forceps type.

Primary Outcome Measure Information:

Title

Comparison of the cure rates between the mini sling and classical transobturator tapes

Description

Percentage of patients who are regarded as cured or improved based on the following criteria: Negative Cough Stress test 1 year after surgery Pad Test < 2 g 1 year after surgery

Time Frame

Up to one year

Secondary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Comparison of the intra- and postoperative complications between procedures

Time Frame

0, 1, 6 and 12 months after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged over 18 years Clinical and urodynamic diagnosis of stress urinary incontinence Absence of associated neurological diseases No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts) Exclusion Criteria: urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction Coagulopathies Pregnancy History of sensitivity to foreign body Acute Urinary Tract Infection Sequelae of high exposure to ionizing radiation Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting anesthetic contraindication to the procedure Vulvovaginitis: presence of vaginal discharge with laboratory proven infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

EMERSON OLIVEIRA, PhD

Organizational Affiliation

FACULTY OF MEDICINE OF ABC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine of ABC

City

Santo André

State/Province

São Paulo

ZIP/Postal Code

09060-650

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence

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