Silodosin Versus Tamsulosin for Treatment of Ureteral Stones

NCT02369744 | Terminated Phase 4 Results

• 1 other identifier: HN 4441
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency Department (ED) visits. These stones can get caught in the ureter (the tube connecting the kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as the obstructing stone meets certain conditions and the patient isn't too sick, the patient is usually sent home to try and pass the stone without surgery. This treatment is known as medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin, which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a drug in the same class of tamsulosin, but which is thought to have a more selective action and a quicker onset, which would theoretically make it better for aiding in kidney stone passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs to see how quickly they result in stone passage. Subjects are patients presenting to the ED with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is that silodosin will have decreased time to stone passage compared to tamsulosin. Subjects who qualify and consent are randomized to a two-week course of either silodosin or tamsulosin. They are also given prescriptions for standard of care medications for pain and nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind them of their follow-up appointment, ask about adverse events, and determine if their stone has passed. They have a follow-up visit with study staff at the end of their two week treatment to collect their pain diary, pill count, adverse events, and to determine if their stone has passed. Study participation ends after this follow-up visit.

Conditions

Ureteral Calculus; Ureterolithiasis; Ureteral Stone

Keywords

Ureteral calculus; Ureterolithiasis; Ureteral stone; Kidney stone; Medical expulsive therapy; tamsulosin; silodosin; rapaflo; flomax

Outcome Measures

Primary Outcomes (1)

• Time to Stone Passage

  The primary outcome measure will be the time it takes for the stone to pass. Stone passage will be defined as the subject self-reporting passage of a stone that is consistent with their imaging, or resolution of their pain to suggest unseen passage of their stone. This outcome will be measured from the initial emergency department visit, and gathered at the one-week follow-up call as well as the two-week follow-up visit.

  at 2 weeks

Secondary Outcomes (3)

• Use of Pain Medication

  at 2 weeks

• Outpatient Treatment Failure

  at 2 weeks

• Adverse Hemodynamic Reaction

  at 2 weeks

Study Arms (2)

Silodosin

ACTIVE COMPARATOR

Subjects in the Silodosin Group will be given silodosin 8 mg tablets, one tablet to be taken PO each day for two weeks.

Drug: Silodosin

Tamsulosin

ACTIVE COMPARATOR

Subjects in the Tamsulosin Group will be given tamsulosin 0.4 mg tablets, one tablet to be taken PO each day for two weeks.

Drug: Tamsulosin

Interventions

Silodosin DRUG

8mg tablet, 1 tab PO daily for 2 weeks

Also known as: Rapaflo

Silodosin

Tamsulosin DRUG

0.4 mg Tab, 1 tab PO daily for 2 weeks

Also known as: Flomax

Tamsulosin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 to 70 years
• Non-diabetic
• Unilateral ureteral calculus 4 to 10 mm visible on CT scan within the ureter
• Serum creatinine level within normal range
• Ability to tolerate oral fluids and oral pain medication
• Ability to make informed medical decisions regarding consent
• Willingness to follow up in the ER in two weeks

You may not qualify if:

• Adults unable to consent
• Age \<18
• Signs of infection including Temperature \>38º C or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count \>5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of \>100,000 CFU)
• Patients with chronic pain already undergoing treatment with narcotic medications
• Patients already taking an alpha adrenergic antagonist medication
• Pregnant women
• Prisoners
• No working phone number

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (8)

• Hollingsworth JM, Rogers MA, Kaufman SR, Bradford TJ, Saint S, Wei JT, Hollenbeck BK. Medical therapy to facilitate urinary stone passage: a meta-analysis. Lancet. 2006 Sep 30;368(9542):1171-9. doi: 10.1016/S0140-6736(06)69474-9.

  PMID: 17011944 BACKGROUND

• Parsons JK, Hergan LA, Sakamoto K, Lakin C. Efficacy of alpha-blockers for the treatment of ureteral stones. J Urol. 2007 Mar;177(3):983-7; discussion 987. doi: 10.1016/j.juro.2006.10.023.

  PMID: 17296392 BACKGROUND

• Pedro RN, Hinck B, Hendlin K, Feia K, Canales BK, Monga M. Alfuzosin stone expulsion therapy for distal ureteral calculi: a double-blind, placebo controlled study. J Urol. 2008 Jun;179(6):2244-7; discussion 2247. doi: 10.1016/j.juro.2008.01.141. Epub 2008 Apr 18.

  PMID: 18423747 BACKGROUND

• Steinberg PL. Re: Karim Bensalah, Margaret Pearle and Yair Lotan. Cost-effectiveness of medical expulsive therapy using alpha-blockers for the treatment of distal ureteral stones. Eur urol 2008;53:411-9. Eur Urol. 2008 Aug;54(2):469; author reply 469. doi: 10.1016/j.eururo.2008.01.077. Epub 2008 Feb 4. No abstract available.

  PMID: 18281146 BACKGROUND

• Hermanns T, Sauermann P, Rufibach K, Frauenfelder T, Sulser T, Strebel RT. Is there a role for tamsulosin in the treatment of distal ureteral stones of 7 mm or less? Results of a randomised, double-blind, placebo-controlled trial. Eur Urol. 2009 Sep;56(3):407-12. doi: 10.1016/j.eururo.2009.03.076. Epub 2009 Apr 3.

  PMID: 19375849 BACKGROUND

• Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck AC, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Turk C, Wolf JS Jr; American Urological Association Education and Research, Inc; European Association of Urology. 2007 Guideline for the management of ureteral calculi. Eur Urol. 2007 Dec;52(6):1610-31. doi: 10.1016/j.eururo.2007.09.039. No abstract available.

  PMID: 18074433 BACKGROUND

• Kobayashi S, Tomiyama Y, Hoyano Y, Yamazaki Y, Sasaki S, Kohri K. Effects of silodosin and naftopidil on the distal ureter and cardiovascular system in anesthetized dogs: comparison of potential medications for distal ureteral stone passage. J Urol. 2010 Jan;183(1):357-61. doi: 10.1016/j.juro.2009.08.106.

  PMID: 19914658 BACKGROUND

• H Lepor et al. Double-Blind, Randomized, Parallel-Group Study To Define Electrocardiographic Effects Of Silodosin. Journal of Urology 179(4), May 2008

  BACKGROUND

MeSH Terms

Conditions

Ureteral Calculi; Ureterolithiasis; Kidney Calculi

Interventions

silodosin; Tamsulosin

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

0 Participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available

Results Point of Contact

• Title: Kamran Mohiuddin; Director ED Clinical Research
• Organization: Albert Einstein Medical Center

MOHIUDDK@EISNTEIN.EDU

2154562313

Study Officials

• William Boroughf, DO

  Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

• James Gardner, MD

  Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: February 24, 2015
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 23, 2020
• Results First Posted: March 19, 2020

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)