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Идёт набор NCT07377929

Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms

— Наблюдательное Benign Prostatic Hypertrophy (BPH) Lower Urinary Track Symptoms

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: Survey using a questionnaire..
Кому может быть актуально
Состояния в реестре: Benign Prostatic Hypertrophy (BPH), Lower Urinary Track Symptoms. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Patients with longstanding obstructive lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH) can also develop symptoms of overactive bladder syndrome (OAB). Transurethral resection of the prostate (TURP) and Transurethral Waterjet Ablation of the Prostate (Aquablation) are amongst the gold standard surgical treatments for BPH. However, in the immediate post-operative period, TURP and Aquablation can also include OAB-like symptoms, including urinary frequency and urgency. For men with baseline OAB symptoms, this initial worsening of symptoms can be distressing. Botox is an FDA approved medication with on-label indications to treat overactive bladder. The purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP or Aquablation.

Вмешательства

  • Другое Survey using a questionnaire.
    * 1 week post-operative visit for: trial of void, to assess for rates of postoperative urinary retention. * 4 and 12 week post-operative visits for: post void residual assessment via bladder scan, AUA symptom score, PGI-I, UDI-6, and VM Post Procedure questionnaires will be administered * Hospitalization readmission rates, urinary retention episodes will also be recorded.

Первичные конечные точки

  • To identify whether concurrent Botox and TURP or Aquablation are effective at reducing post-operative irritative voiding symptoms. [Срок оценки: 4 months]
Вторичные конечные точки (2)
  • To identify whether concurrent Botox and TURP or Aquablation lead to longer hospitalizations. [Срок оценки: 4 months]
  • To identify whether concurrent Botox and TURP or Aquablation lead to higher rates of urinary retention. [Срок оценки: 4 months]

Критерии участия

Критерии включения

  • Male >= 18 years of age and being scheduled to undergo TURP or Aquablation and Botox procedure.
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Критерии исключения

  • Non-English speaking
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • History of receiving Botox in the bladder, within the previous 12 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Virginia Mason Franciscan Health — Seattle

Публикации

  • Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206. PMID 7780440
  • Yap TL, Cromwell DA, Brown C, van der Meulen J, Emberton M. The relationship between objective frequency-volume chart data and the I-PSS in men with lower urinary tract symptoms. Eur Urol. 2007 Sep;52(3):811-8. doi: 10.1016/j.eururo.2007.01.013. Epub 2007 Jan 12. PMID 17276583
  • Palnaes Hansen C, Klarskov P. The accuracy of the frequency-volume chart: comparison of self-reported and measured volumes. Br J Urol. 1998 May;81(5):709-11. doi: 10.1046/j.1464-410x.1998.00627.x. PMID 9634046
  • Zillioux J, Welk B, Suskind AM, Gormley EA, Goldman HB. SUFU white paper on overactive bladder anticholinergic medications and dementia risk. Neurourol Urodyn. 2022 Nov;41(8):1928-1933. doi: 10.1002/nau.25037. Epub 2022 Sep 6. PMID 36066046
  • Al-Shaiji TF. Intradetrusor injection of botulinum toxin for the management of refractory overactive bladder syndrome: an update. Surg Innov. 2013 Aug;20(4):351-5. doi: 10.1177/1553350612460125. Epub 2012 Sep 10. PMID 22964263
  • Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.07 PMID 23098785
  • Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8. PMID 31039103
  • Kim SJ, Al Hussein Alawamlh O, Chughtai B, Lee RK. Lower Urinary Tract Symptoms Following Transurethral Resection of Prostate. Curr Urol Rep. 2018 Aug 20;19(10):85. doi: 10.1007/s11934-018-0838-4. PMID 30128964

Идентификаторы

NCT: NCT07377929 · IRB24-069

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗