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

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

1. 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.

2. 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.

Study Overview

• Status: Completed
• Conditions: Injury Due to Sling-shot
• Intervention / Treatment: Device: Ophira; Device: Transobturator sling

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Santo André, São Paulo, Brazil, 09060-650
      • FACULTY OF MEDICINE OF ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single incision mini-sling; Experimental group: surgery to treat stress urinary incontinence with the Ophira mini sling systemt®	Device: Ophira; The procedure will be perfomed with a single incision in anterior wall vagina
Active Comparator: Transobturator sling; Control group: surgery to treat stress urinary incontinence with the Unitape T Plus®.	Device: Transobturator sling; 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.; Other Names: Unitape T plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Comparison of the intra- and postoperative complications between procedures	0, 1, 6 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 22, 2014
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: stress incontinence; transobturator sling; single-incision mini-sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: URO-2009