Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery

Официальное название

The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study

Обзор

The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.

Подробное описание

The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo.

Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.

Вмешательства

• Препарат Tamsulosin
  Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
• Препарат Placebo
  Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.

Первичные конечные точки

• To determine the impact of Tamsulosin on duration of urinary retention [Срок оценки: Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course]

Вторичные конечные точки (2)

• To assess the impact of Tamsulosin on rates of urinary tract infection (UTI). [Срок оценки: Date of failed the retrograde voiding trial and up to 6 weeks.]
• To quantify the effect of Tamsulosin on patient quality of life. [Срок оценки: Prior to discharge and again at 2 weeks follow up]

Критерии участия

Критерии включения

• 18 years or older
• willing and able to provide informed consent
• postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
• Ability to speak and read English
• Tolerate pill ingestion

Критерии исключения

• allergy/intolerance to Tamsulosin or sulfa drugs
• preoperative history of urinary retention as defined by preoperative post void residual of >150mL
• current use of alpha antagonist medication for hypertension
• severe dementia
• end stage renal or liver disease
• history of severe heart failure or major cardiovascular event in the last 6 months

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• West Penn Hospital — Pittsburgh

Публикации

• Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743. PMID 31157716
• Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd. PMID 21860294
• Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3. PMID 22752014
• Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. d PMID 20175247
• K Ramakrishnan, J Mold. Urinary Catheters: A Review. The Internet Journal of Family Practice. 2004 Volume 3 Number 2.
• Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea. PMID 19352147
• Kuipers PW, Kamphuis ET, van Venrooij GE, van Roy JP, Ionescu TI, Knape JT, Kalkman CJ. Intrathecal opioids and lower urinary tract function: a urodynamic evaluation. Anesthesiology. 2004 Jun;100(6):1497-503. doi: 10.1097/00000542-200406000-00023. PMID 15166570
• Darrah DM, Griebling TL, Silverstein JH. Postoperative urinary retention. Anesthesiol Clin. 2009 Sep;27(3):465-84, table of contents. doi: 10.1016/j.anclin.2009.07.010. PMID 19825487

Идентификаторы

NCT: NCT04597372 · IRB00264995

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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