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

NCT ID: NCT02540525

Last Updated: 2015-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-07-31

Brief 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.

Conditions

Injury Due to Sling-shot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single incision mini-sling

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

Group Type: EXPERIMENTAL

Ophira

Intervention Type: DEVICE

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

Transobturator sling

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

Group Type: ACTIVE_COMPARATOR

Transobturator sling

Intervention Type: DEVICE

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.

Interventions

Ophira

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Unitape T plus

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Faculdade de Medicina do ABC

OTHER

Sponsor Role: lead

Responsible Party

Emerson Oliveira

Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EMERSON OLIVEIRA, PhD

Role: PRINCIPAL_INVESTIGATOR

FACULTY OF MEDICINE OF ABC

Locations

Faculty of Medicine of ABC

Santo André, São Paulo, Brazil

Countries

Brazil

References

Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

Reference Type: DERIVED

PMID: 37888839 (View on PubMed)

Other Identifiers

URO-2009

Identifier Type: -

Identifier Source: org_study_id