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Набор скоро начнётся NCT06606613

Cross-linked Hyaluronic Acid/dextranomer for the Treatment of Stress Urinary Incontinence

Фаза II С лечением Urinary Stress Incontinence (SI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intraurethral injection, Mid-urethral sling.
Кому может быть актуально
Состояния в реестре: Urinary Stress Incontinence (SI). Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Midurethral Sling Versus Cross-linked Hyaluronic Acid/dextranomer (CLHA/Dx) for the Treatment of Stress Urinary Incontinence

Обзор

The investigators aimed to evaluate the effectiveness and safety of intraurethral cross-linked hyaluronic acid/dextranomer (CLHA/Dx) injection for the treatment of stress urinary incontinence (SUI) in women.

Подробное описание

This single-center prospective pre-post interventional study was conducted between October 2025 and April 2025 with 60 women . Quality of life was evaluated with the Incontinence Quality of Life Scale (I-QoL) and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Incontinence status was assessed via the Stamey Incontinence Grade scale. The need for additional treatment (re-injection, other surgical approaches, etc.) was recorded.

Participants were followed up to 6 months after intervention. All outcomes of interest and complications were evaluated/recorded at three preplanned visits (postoperative 1st, 3rd, 6th, months).

Вмешательства

  • Процедура Intraurethral injection
    Procedure: Intraurethral injection Patients are positioned in the lithotomy position during the procedure. General and/or local anesthesia is administered depending on the investigator\'s preference. An applicator developed for intraurethral injection will be used. This device comprises a holder that is placed into and fixates the urethra (i.e., it distends the urethral circumference, thus smoothing out the longitudinal folds), allowing the use of four syringes to inject cross-linke
  • Процедура Mid-urethral sling
    Procedure: Starting with the dorsal lithotomy position, a foley catheter is inserted to the urethra. Starting with 1-1.5 cm below the urethral meatus, a 1.5-2 cm vertical incision is made. Following the dissection of anterior vaginal mucosa, pubocervical fascia should be dissected sharply . Dissection is continued laterally to the ischiopubic ramus. Starting downwards from the tendinous insertion of the adductor longus muscle at the level of clitoris, a 1cm incision is made close to the bone. T

Первичные конечные точки

  • Need for addtional treatment within the 3st month [Срок оценки: Within the 3 st month]
  • Need for addtional treatment within the 1st month [Срок оценки: Within the 1st month]
  • Need for addtional treatment within the 6 st month [Срок оценки: Within the 6 st month]
  • Presence of complication within 6 months after intervention [Срок оценки: Within 6 months after intervention]
  • Change in the Stamey Incontinence Grade at 6months [Срок оценки: Change from baseline at 6months.]
  • Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 [Срок оценки: Change from baseline at 3 month]
  • Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month [Срок оценки: Change from baseline at 1 month]
  • Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 month [Срок оценки: Change from baseline at 6 month]
  • Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months [Срок оценки: Change from baseline at 3 month]
  • Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months [Срок оценки: Change from baseline at 6 month]

Критерии участия

Критерии включения

  • Diagnosis of Stress Urinary Incontinence.
  • Presence of incontinence during the Valsalva maneuver.
  • Positive Marshall-Marchetti test result.
  • Post-void residual urine volume of ≤100 mL.

Критерии исключения

  • Temporary urinary incontinence.
  • Delirium.
  • Urinary tract infection.
  • Urethritis.
  • Pure urge incontinence.
  • Nocturnal enuresis.
  • Decreased bladder compliance or detrusor contraction observed in urodynamic -studies.
  • Leakage of urine with low bladder pressure.
  • Psychiatric conditions (severe depression and anxiety).
  • Body mass index (BMI) \> 35 kg/m².
  • Use of medications that may influence bladder storage or emptying.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • İzmir Bakircay University — Izmir

Идентификаторы

NCT: NCT06606613 · 170924

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗