Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Официальное название

A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Обзор

This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).

Подробное описание

The BASIS trial is a multicentered, double-blind, randomized controlled, surgical trial with two active interventions, 1) a transurethral bulking agent (TBA) or 2) a single-incision sling (SIS). Both interventions are FDA-approved treatment options for urinary incontinence and will be used in line with their approved use. Participants will be randomly assigned to one of the interventions. A total of 358 women will be randomized 1:1 to TBA or SIS.

All participants will have data including demographics, medical history, and quality of life assessments as they relate to urinary incontinence collected at baseline. After undergoing treatment (either transurethral bulking agent or single-incision sling), participants will be asked to return to the clinic at 2-4 weeks, 3 months, and 12 months with additional follow-ups at 6 months, 24 months, and 36 months done over the phone.

The primary outcome of the BASIS trial is subjective success measured by PGI-I for TBA vs. SIS at 12 months.

Secondary outcomes include assessments of 1) retreatment rates within 12 months; 2) validated, objective measures of condition improvement through 36 months; 3) objective success at 3 and 12 months as measured by standardized cough stress test; 4) functional outcomes (activity level, perceived recover, sexual function, etc.); 5) quality of life assessments; 6) operative procedure data and adverse events; 7) pain and functional activity, need for sedation and anesthesia, de novo or worsening symptoms; 8) medical resource use (additional medications, procedures, or therapies); and 9) healthy utility measures.

Вмешательства

• Устройство Solyx Single-incision Sling
  Minimally invasive mesh device placed to treat stress urinary incontinence.
• Устройство Bulkamid Transurethral Bulking Agent
  Minimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed

Первичные конечные точки

• Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months. [Срок оценки: At 12 months post-intervention.]

Вторичные конечные точки (12)

• Rates of retreatment [Срок оценки: From intervention to 12 months post-intervention.]
• Change in Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF] score [Срок оценки: From intervention to 36 months post-intervention.]
• Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS [Срок оценки: From 3 months to 36 months post-intervention.]
• Condition improvement measured by Patient Global Symptom Control [PGSC] for TBA vs. SIS [Срок оценки: From interventions to 36 months post-intervention.]
• Condition improvement measured by Patient Global Impression of Severity [PGI-S] for TBA vs. SIS [Срок оценки: From intervention to 36 months post-intervention.]
• Condition improvement measured by Urogenital Distress Inventory - Long Form [UDI-LF] for TBA vs. SIS [Срок оценки: From intervention to 36 months post-intervention.]
• Objective success by standardized cough testing [Срок оценки: From 3 to 12 months post-intervention.]
• New or worsening urge incontinence function [Срок оценки: From intervention to 36 months post-intervention.]
• Sexual functional measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised [PISQ-IR] for TBA vs. SIS [Срок оценки: From intervention to 36 months post-intervention.]
• Quality of life improvement measured by Incontinence Impact Questionnaire - Long Form [IIQ-LF] for TBA vs. SIS [Срок оценки: From baseline to 36 months post-intervention.]
• Quality of life improvement measured by 36-Item Short Form Health Survey [SF-36] for TBA vs. SIS [Срок оценки: From baseline to 36 months post-intervention.]
• Quality of life improvement measured by Decision Regret Scale- Satisfaction with Decision Scale [DRS-SDS] for TBA vs. SIS [Срок оценки: From baseline to 36 months post-intervention.]

Критерии участия

Критерии включения

• Women ≥ 21 years
• For > 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required.
• A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months.
• Normal PVR < 150 mL
• Candidate for either study procedure as determined by treating surgeon
• Available for up to 3 years.
• Agrees to randomization.

Критерии исключения

• Anterior/apical vaginal prolapse beyond the hymen (>0 on POPQ)
• Urge-predominant mixed UI despite stable therapy
• Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment.
• Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months.
• Malignancy or history of radiation of the pelvis
• Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year
• Incomplete emptying (PVR > 150mL)
• Prior anti-incontinence procedure
• Neurogenic bladder
• Unwilling to continue current UUI treatment until completion of primary outcome at 12 months
• Prior adverse reaction to synthetic mesh or urethral bulking material
• Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.)
• Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 7 центров

• University of California at San Diego — La Jolla
• Kaiser Permanente -- San Diego — San Diego
• University of Chicago — Chicago
• Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham
• University of Pennsylvania — Philadelphia
• Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstru — Providence
• University of Texas Southwestern Medical Center — Dallas

Публикации

• Lukacz ES, Menefee SA, Carper B, Collins S, McMillian K, Florian-Rodriguez M, Rardin C, Weidner AC, Harvie HS, Alexander B, Mazloomdoost D; NICHD Pelvic Floor Disorders Network. Design of Transurethral Bulking Agent Injection Versus Single-Incision Sling Trial. Urogynecology (Phila). 2026 Feb 1;32(2):131-141. doi: 10.1097/SPV.0000000000001702. PMID 41428458

Идентификаторы

NCT: NCT06480227 · PFDN-33P01 · UG1HD069013 · UG1HD054214 · UG1HD041267 · UG1HD054241 · UG1HD110057 · UG1HD069010 · U24HD069031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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