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Completed

NCT Number: NCT02540525

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

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.

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Key information

Conditions

Injury Due to Sling-shot Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine of ABC

Santo André, São Paulo, 09060-650, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ophira

Device

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

Transobturator sling

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.

Other names: Unitape T plus

Primary outcomes

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

    Time frame: Up to one year

    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 outcomes

  1. Number of participants with adverse events

    Time frame: 0, 1, 6 and 12 months after surgery

    Comparison of the intra- and postoperative complications between procedures

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2015
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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