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

NCT04597372 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB00264995
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Retention Postoperative

Outcome Measures

Primary Outcomes (1)

• To determine the impact of Tamsulosin on duration of urinary retention

  The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.

  Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course

Secondary Outcomes (2)

• To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).

  Date of failed the retrograde voiding trial and up to 6 weeks.

• To quantify the effect of Tamsulosin on patient quality of life.

  Prior to discharge and again at 2 weeks follow up

Study Arms (2)

Tamsulosin

EXPERIMENTAL

10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR

10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Drug: Placebo

Interventions

Tamsulosin DRUG

Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.

Tamsulosin

Placebo DRUG

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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Johns Hopkins University: collaborator

Study Sites (1)

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Related Publications (21)

• 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

• 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 BACKGROUND

• 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. doi: 10.1086/650482.

  PMID: 20175247 BACKGROUND

• K Ramakrishnan, J Mold. Urinary Catheters: A Review. The Internet Journal of Family Practice. 2004 Volume 3 Number 2.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Lose G, Lindholm P. Prophylactic phenoxybenzamine in the prevention of postoperative retention of urine after vaginal repair: a prospective randomized double-blind trial. Int J Gynaecol Obstet. 1985 Sep;23(4):315-20. doi: 10.1016/0020-7292(85)90026-8.

  PMID: 2866119 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

• Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.

  PMID: 18082216 BACKGROUND

• Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998 Jun;51(6):892-900. doi: 10.1016/s0090-4295(98)00126-5.

  PMID: 9609623 BACKGROUND

• FDA Prescription Drug Advisory Rule for Tamsulosin. NDA 020579.C.F.R. Accessed 4/3/20. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020579

  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

• Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol. 1998 Nov;160(5):1701-6.

  PMID: 9783935 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

• Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005 Aug;14(6):1523-32. doi: 10.1007/s11136-004-7713-0.

  PMID: 16110932 BACKGROUND

• Harvie HS, Honeycutt AA, Neuwahl SJ, Barber MD, Richter HE, Visco AG, Sung VW, Shepherd JP, Rogers RG, Jakus-Waldman S, Mazloomdoost D; NICHD Pelvic Floor Disorders Network. Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse. Am J Obstet Gynecol. 2019 Mar;220(3):265.e1-265.e11. doi: 10.1016/j.ajog.2018.11.1094. Epub 2018 Nov 22.

  PMID: 30471259 BACKGROUND

• Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102.

  PMID: 30741813 BACKGROUND

• Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110.

  PMID: 25185611 BACKGROUND

• Clinicaltrial.gov. Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders Accessed 4/3/20: https://clinicaltrials.gov/ct2/show/NCT04232683?term=tamsulosin&draw=2&rank=1

  BACKGROUND

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lindsay Turner, MD

  Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Turner

CONTACT

(412)-330-4567; lindsay.turner@AHN.ORG

AHN Clinical Trials Contact

CONTACT

(412)-330-4567; clinicaltrials@ahn.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urogynecology, Principal Investigator

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 22, 2020
• Study Start: November 3, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)