Clinical trial NCT03524339: Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
Official title: Perioperative Administration of Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Retention
Lower Urinary Tract Symptoms
Stress Urinary Incontinence
Pelvic Organ Prolapse
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a placebo controlled randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years or older as well as willing and able to provide informed consent
* Patients must be undergoing a scheduled surgery for pelvic organ prolapse or urinary incontinence
* Standard postoperative plan must include admission to the hospital with foley catheterization overnight the night after surgery, and planned removal of foley catheter and active voiding trial on postoperative day 1.

Exclusion Criteria:

* Patient unable or unwilling to provide informed consent
* Severe allergy to sulfa drugs
* Known allergy to tamsulosin or another alpha antagonist medication
* History of urinary retention
* Planned bladder catheterization greater than 24 hours after surgery
* Current use of alpha antagonist medication for hypertension
* End stage renal or liver disease

Primary outcomes:
measure: Postoperative Urinary Retention
timeFrame: Within 72 hours of surgery
Secondary outcomes:
measure: International Prostate Symptom Score
timeFrame: Within 1 week of surgery
measure: Postoperative Urinary Tract Infection
timeFrame: Within 6 weeks after surgery
measure: Sent Home With Catheterization
timeFrame: within 6 weeks of surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals Case Western Reserve University
name: Graham Chapman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hakvoort RA, Dijkgraaf MG, Burger MP, Emanuel MH, Roovers JP. Predicting short-term urinary retention after vaginal prolapse surgery. Neurourol Urodyn. 2009;28(3):225-8. doi: 10.1002/nau.20636.
citation: Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16.
citation: Espaillat-Rijo L, Siff L, Alas AN, Chadi SA, Zimberg S, Vaish S, Davila GW, Barber M, Hurtado EA. Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1378-1383. doi: 10.1097/AOG.0000000000001750.
citation: FitzGerald MP, Brubaker L. The etiology of urinary retention after surgery for genuine stress incontinence. Neurourol Urodyn. 2001;20(1):13-21. doi: 10.1002/1520-6777(2001)20:13.0.co;2-r.
citation: Reitz A, Haferkamp A, Kyburz T, Knapp PA, Wefer B, Schurch B. The effect of tamsulosin on the resting tone and the contractile behaviour of the female urethra: a functional urodynamic study in healthy women. Eur Urol. 2004 Aug;46(2):235-40; discussion 240. doi: 10.1016/j.eururo.2004.04.009.
citation: Pummangura N, Kochakarn W. Efficacy of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) in women. Asian J Surg. 2007 Apr;30(2):131-7. doi: 10.1016/S1015-9584(09)60146-9.
citation: Zhang HL, Huang ZG, Qiu Y, Cheng X, Zou XQ, Liu TT. Tamsulosin for treatment of lower urinary tract symptoms in women: a systematic review and meta-analysis. Int J Impot Res. 2017 Jul;29(4):148-156. doi: 10.1038/ijir.2017.12. Epub 2017 Apr 20.
citation: Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05.
citation: Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A. Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Int Braz J Urol. 2016 May-Jun;42(3):578-84. doi: 10.1590/S1677-5538.IBJU.2015.0256.
citation: Poylin V, Curran T, Cataldo T, Nagle D. Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. Int J Colorectal Dis. 2015 Sep;30(9):1223-8. doi: 10.1007/s00384-015-2294-7. Epub 2015 Jun 23.
citation: Chapman GC, Sheyn D, Slopnick EA, Roberts K, El-Nashar SA, Henderson JW, Mangel J, Hijaz AK, Pollard RR, Mahajan ST. Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2021 Sep;225(3):274.e1-274.e11. doi: 10.1016/j.ajog.2021.04.236. Epub 2021 Apr 21.