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Urinary Tract Calculi VI: Surgical Management01:25

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Procedures for Kidney StonesMedical intervention is necessary when kidney stones or renal calculi are too large to pass spontaneously (typically greater than 5 millimeters) when stones are accompanied by symptomatic infection (such as fever or pyelonephritis), when they impair kidney function, or when they cause persistent symptoms like severe pain, nausea, or urinary retention. Additionally, patients with only one kidney or those who cannot be treated with medical management also require...
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The BASIS trial compares transurethral bulking agent injections and single incision slings for stress urinary incontinence. Results will offer level 1 evidence on these minimally invasive treatments.

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Area of Science:

  • Urology
  • Minimally Invasive Surgery
  • Female Pelvic Medicine

Background:

  • Transurethral bulking agent (TBA) injections and single incision slings (SIS) are increasingly used for primary stress urinary incontinence (SUI).
  • Comparative trials evaluating these minimally invasive options are lacking.

Purpose of the Study:

  • To describe the study design and rationale for the Transurethral Bulking Agent Injection versus Single-Incision Sling for Stress Urinary Incontinence (BASIS) trial.
  • To provide level 1 evidence on the comparative effectiveness of TBA injections and SIS for primary SUI.

Main Methods:

  • A multicentered, double-blind, randomized controlled superiority trial comparing TBA (Bulkamid) with SIS (Solyx).
  • Eligible participants are women with primary, stress-predominant SUI suitable for office-based anesthesia.
  • Primary outcome is Patient Global Impression of Improvement; secondary outcomes include objective/subjective success, retreatment, adverse events, and cost-effectiveness.

Main Results:

  • The BASIS trial is designed to enroll 358 participants with a 36-month follow-up period.
  • The study will evaluate efficacy, safety, and cost-effectiveness of TBA injections versus SIS.
  • Feasibility of an office-based anesthesia protocol will also be assessed.

Conclusions:

  • Results from the BASIS study will provide crucial level 1 evidence on two leading minimally invasive treatments for primary SUI.
  • Long-term safety data and 3-year outcomes will aid clinical decision-making for SUI management.