Desara ® One Single Incision Sling 522 Study

Официальное название

Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence

Обзор

A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.

Подробное описание

This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 2 and 6 weeks, 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Вмешательства

• Устройство Desara® One Single Incision Sling
  Single incision sling
• Устройство Desara® Blue Transobturator Sling
  Standard mid-urethral sling

Первичные конечные точки

• Success rate of negative standing cough stress test (CST) [Срок оценки: 36 months]
• Device and Procedure-related serious adverse events [Срок оценки: 36 months]

Вторичные конечные точки (7)

• Composite outcome success rates [Срок оценки: 6 weeks, 6, 12, 18, 24, 36 months]
• Sexual Function Assessment [Срок оценки: 6 weeks, 6, 12, 18, 24, 36 months]
• Improvement in Incontinence [Срок оценки: 6 weeks, 6, 12, 18, 24, 36 months]
• Improvement in Urinary Symptoms [Срок оценки: 6 weeks, 6, 12, 18, 24, 36 months]
• Improvement in Urge and Stress Incontinence [Срок оценки: 6 weeks, 6, 12, 18, 24, 36 months]
• Subject pain assessment [Срок оценки: 6 weeks, 6, 12, 18, 24, 36 months]
• Time to void post-implant [Срок оценки: 6 weeks, 6, 12, 18, 24, 36 months]

Критерии участия

Критерии включения

• Female ≥ 18 of age.
• Subject agrees that she is willing and able to return for all study related procedures and evaluations.
• Subject has provided signed informed consent.
• Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound.
• Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
• Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:

• A hysterectomy or
• Tubal ligation or
• Is otherwise incapable of pregnancy or has
• Negative pregnancy test prior to study entry and has decided to cease childbearing
• Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
• Subject is eligible to undergo laparoscopic/robotic (with or without mesh) or vaginal (with or without mesh) apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh).

Критерии исключения

• Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
• Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
• Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
• Subject has a history of chronic opioid, or narcotic use for:

• pain or
• any other specified reason
• Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
• Subject is on chronic (> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
• Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose > 130mg/dl at screening/baseline.
• Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
• Subject has active UTI which requires treatment, as determined by the Investigator.
• Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
• Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
• The subject has had:

• any prior surgical stress urinary incontinence treatment or
• any prior surgery on their urethra or
• any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
• any previous pelvic floor mesh use or complication
• Subject has any of the following confounding conditions:

• bladder stones or tumors
• pathology that in the opinion of the Investigator would compromise implant placement
• pathology that would limit pelvic blood supply
• pathology that would require chemotherapy and systemic use of immunosuppressants
• Subject has abnormal bladder capacity <300 mL.
• Subject has a post void residual volume ≥ 150 mL on two different measurements. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)
• Subject has had previous radiation therapy or brachytherapy to the pelvis.
• Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, interfere with clinical outcomes, or impact analysis of this device.
• Subject has known reaction, sensitivity or allergy to polypropylene.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Valley Urogynecology Associates, Inc. — Phoenix
• University of Arizona College of Medicine — Tucson
• Urological Research Center Corp — Hialeah
• Women's Health Care Associates P.A. dba Rosemark Women Care Specialists — Idaho Falls
• CMB Research, LLC — Newburgh
• University of Louisville — Louisville
• Mt. Auburn Hospital Division of Urogynecology — Cambridge
• Specialty Clinical Research of St. Louis, LLC — St Louis
• … и ещё 7 центров

Идентификаторы

NCT: NCT04772131 · PS200005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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