BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)

Официальное название

BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair

Обзор

The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.

Подробное описание

This will be a double-blinded, non-inferiority, controlled trial utilizing a 1:1 randomization scheme to assign patients to each treatment arm (PAHG vs. RP-MUS). Patients undergoing PAHG will be given sham incisions in order to mask the type of SUI procedure they underwent. This will consist of two "earring-hole" sized superficial scratches in the epidermis and fibrin glue applied to the expected suprapubic exit sites for the RP-MUS. Sham incisions are not associated with an increased risk of infection and are considered low risk. Validated symptom questionnaires will be administered to the patient by a study investigator prior to surgery and at 1, 6, 12, and 24 months. At the final study visit, patients will be un-blinded and provided information on which SUI procedure they underwent. Unless it is necessary for subsequent care, as in the case of a procedure specific complication like a mesh erosion, patients who might require additional intervention for recurrent SUI during the study period will remain blinded to their initial treatment assignment. If patients request this information, they will be informed that they would need to exit the study, however their data would still be analyzed as part of the intention to treat protocol. Data of patients who dropout will be analyzed in the same manner. Pelvic organ prolapse procedures will be limited to native tissue repairs only and may include either or both apical and non-apical repair procedures; selection of appropriate POP repair procedure will be at the surgeon's discretion. All randomized patients will complete surveys at 12 and 24 months will assess patient recovery, satisfaction with care, and calibrating surveyed and clinically assessed outcomes to their daily life experiences. Based on prior similar studies, this number is sufficient to ensure saturation of themes83. Between 8 to 20 participants in each arm will be randomly selected from across all sites to participate in individual semi-structured telephone interviews preoperatively, at 12 months and at 24 months after surgery.

Вмешательства

• Устройство RP-MUS
  a standard urethral sling placement for treatment of stress urinary incontinence
• Процедура PAHG
  A standard 2 mL dose injection of bulkamid (order and number will be at the discretion of the surgeon) will be given. Patients undergoing PAHG will be given sham incisions consisting of superficial suprapubic epidermal scratches with a needle and fibrin glue at expected sling exit sites.

Первичные конечные точки

• Bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI) [Срок оценки: 24 months postoperatively]

Вторичные конечные точки (7)

• Change in bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI) [Срок оценки: 1, 6 and 12 months postoperatively]
• Change in patient assessment of improvement as measured by the Patient Global Impression of Improvement (PGI-I) [Срок оценки: 1 month, 6 months, 12 months and 24 months postoperatively]
• Number of retreatment for SUI as measured by medical record review/patient report [Срок оценки: up to 24 months post operatively]
• Change in Lower urinary tract dysfunction research network symptom index-29 (LURN-SI-29) [Срок оценки: preoperatively, 1, 6, 12 and 24 months postoperatively]
• Change in Female Sexual Function Inventory (FSFI) [Срок оценки: preoperatively, 1, 6, 12 and 24 months postoperatively]
• Average of Perioperative morbidity [Срок оценки: Up 24 months postoperatively]
• Pelvic organ prolapse recurrence (POP-Q) [Срок оценки: preoperatively, 1, 6, 12 and 24 months postoperatively]

Критерии участия

Критерии включения

• Women ≥ 18 years of age.
• Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR).
• Proof of positive testing for SUI via cough stress test (CST) and/or Urodynamic (UDS) testing,
• Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG)

Критерии исключения

• Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue
• Patient anticipating difficulty with completing 24-month follow-up
• Anticipation of pregnancy within subsequent 24-months or <18 months post-partum
• Hemoglobin A1c >10.0% within the past 3-months
• Current smoker > 1 pack per week
• History of neurogenic bladder
• Current use of any catheterization including but not limited to, intermittent catheterization, indwelling Foley catheter, or suprapubic catheter
• Post-void residual >150 mL felt to not be due to obstruction for prolapse
• Prior history of any anti-incontinence procedure including but not limited to any synthetic sling, fascial sling, Burch colposuspension or its variants, and urethral bulking
• Previous history of any pelvic radiation
• Patient receiving a planned concurrent procedure at the time of prolapse repair.

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 · 1 центр

• University Hospitals Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT06754046 · STUDY20241497

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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