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

Injury Due to Sling-shot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540525
• Other study ID #: URO-2009
• Status: Completed
• Phase: N/A
• First received: February 22, 2014
• Last updated: September 1, 2015
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Injury Due to Sling-shot
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Ophira
The procedure will be perfomed with a single incision in anterior wall vagina
• 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.

Locations

Country	Name	City	State
Brazil	Faculty of Medicine of ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with adverse events	Comparison of the intra- and postoperative complications between procedures	0, 1, 6 and 12 months after surgery	Yes