Effect of Preoperative Tamsulosin on Postoperative Urinary Retention

NCT05753670 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: EH22-470
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 25-30% of patients experience postoperative urinary retention after female pelvic surgery with mid-urethral sling placement. These patients are discharged home with a foley catheter for a few days. Despite being common, many patients consider being discharged home with a foley catheter as a complication of surgery and as the worst part of their experience. Previous studies have demonstrated that 3-5 days of preoperative tamsulosin (a safe and low-cost medication) have been shown to improve postoperative urinary retention rates. Although it takes tamsulosin 5 days to reach a steady-state in a patient, it reaches peak blood volume in 4-5 hours in a fasting patient. The effect of a single dose of preoperative tamsulosin on postoperative urinary retention has not been studied, however would be substantially easier for patients than multiple days of preoperative doses. In this study, the investigators would like to give patients preoperative tamsulosin versus placebo. The investigators would then evaluate for postoperative urinary retention. Previous studies have demonstrated a postoperative urinary retention rate decrease of 65-88% after various tamsulosin protocols. However, the effect of single preoperative dose of tamusloin on postoperative urinary retention has yet to be studied in female pelvic surgery. The investigators hypothesize that a single preoperative dose of tamsulosin will decrease the number of patients with postoperative urinary retention and therefore discharged with a foley catheter. Our goal is to improve patient outcomes and satisfaction postoperatively.

Conditions

Postoperative Retention of Urine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Urinary Retention

  Determine the postoperative urinary retention rates after preoperative administration of tamsulosin compared with placebo. This will be determined immediately postoperative in the postoperative recovery room based on whether patients pass or fail their voiding trial described above. The result will be documented in electronic medical records and obtained from chart review.

  Immediate postoperative evaluation (1 day)

Secondary Outcomes (3)

• Number of Participants With Postoperative Urinary Tract Infection (UTI)

  Chart review of 30 days postoperative after surgery

• Number of Participants With Unplanned Admission or Unplanned Healthcare Encounter

  Chart review of 30 days postoperative after surgery

• Number of Participants With Postoperative Hypotension or Syncope

  Immediate postoperative evaluation (1 day)

Study Arms (2)

Tamsulosin

EXPERIMENTAL

Subjects randomized to the experimental arm will receive a single dose of 0.4mg Tamsulosin tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Drug: Placebo

Interventions

Tamsulosin DRUG

Subjects randomized to the experimental arm will receive a single dose of 0.4mg Tamsulosin tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Tamsulosin

Placebo DRUG

Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mid-urethral sling placement

You may not qualify if:

• Age \<18
• Planned combined cases with colorectal surgery, general surgery, or gynecology-oncology
• Planned sling revision or history of prior sling placement
• Known history of urinary retention
• Concomitant intravesical botulinum injections
• Known contraindication to tamsulosin

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• Wang R, Won S, Haviland MJ, Von Bargen E, Hacker MR, Li J, Lefevre R. Voiding trial outcome following pelvic floor repair without incontinence procedures. Int Urogynecol J. 2016 Aug;27(8):1215-20. doi: 10.1007/s00192-016-2975-y. Epub 2016 Feb 17.

  PMID: 26886553 BACKGROUND

• Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.

  PMID: 20727543 BACKGROUND

• Pomajzl AJ, Siref LE. Postoperative Urinary Retention. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK549844/

  PMID: 31751034 BACKGROUND

• Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.

  PMID: 14710061 BACKGROUND

• Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.

  PMID: 25434837 BACKGROUND

• Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):348-355. doi: 10.1097/AOG.0000000000001472.

  PMID: 27399998 BACKGROUND

• Meyer LE, Brown JN. Tamsulosin for voiding dysfunction in women. Int Urol Nephrol. 2012 Dec;44(6):1649-56. doi: 10.1007/s11255-012-0275-0. Epub 2012 Sep 16.

  PMID: 22983886 BACKGROUND

• 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.

  PMID: 33894146 BACKGROUND

• Livne PM, Kaplan B, Ovadia Y, Servadio C. Prevention of post-hysterectomy urinary retention by alpha-adrenergic blocker. Acta Obstet Gynecol Scand. 1983;62(4):337-40. doi: 10.3109/00016348309156234.

  PMID: 6138916 BACKGROUND

• 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.

  PMID: 24642148 BACKGROUND

• Chapman GC, Sheyn D, Petrikovets A, Mahajan ST, El-Nashar S, Pollard R, Mangel JM. Tamsulosin to Prevent Postoperative Urinary Retention After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Nov;26(11):682-687. doi: 10.1097/SPV.0000000000000650.

  PMID: 30418263 BACKGROUND

• Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.

  PMID: 22741052 BACKGROUND

• Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. doi: 10.2165/00003495-199652060-00012.

  PMID: 8957159 BACKGROUND

• Buckley BS, Sanders CD, Spineli L, Deng Q, Kwong JS. Conservative interventions for treating functional daytime urinary incontinence in children. Cochrane Database Syst Rev. 2019 Sep 18;9(9):CD012367. doi: 10.1002/14651858.CD012367.pub2.

  PMID: 31532563 BACKGROUND

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. Ghazaleh Rostami Nia
• Organization: Endeavor Health

GRostamiNia@northshore.org

847-570-4729

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will occur by simple randomization with a computer-generated random number list. The patient will be randomized to one of the two groups (preoperative tamsulosin 0.4mg tablet versus placebo). This random number list will be sent directly from the statistician to the pharmacy. The clinician will place an order for the preoperative trial medication and the pharmacy will dispense either a single tablet of tamsulosin 0.4mg or placebo to the preoperative holding area according to the randomization list that the pharmacy has been provided by the statistician. The trial medication will be sent from the pharmacy to the preoperative area to be taken prior to surgery. The clinicians, preoperative and postoperative nursing staff, and the patients will be blinded to the trial group and medication.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Division of Urogynecology, NorthShore University HealthSystem

Model Details: This is a prospective randomized, double-blinded, placebo- controlled trial of patients who are undergoing elective mid-urethral sling placement with the Center for Pelvic Health at the Northshore University Health System. Written consent will be obtained. Patients who are undergoing a mid-urethral sling placement will be enrolled (after an informed consent discussion) to receive either a single tablet of tamsulosin 0.4mg or a placebo in the preoperative holding area on the day of their scheduled surgery.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: March 3, 2023
• Study Start: July 1, 2023
• Primary Completion: May 2, 2024
• Study Completion: June 2, 2024
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)