Effect of Furosemide on ESWL Outcomes for Renal and Ureteral Calculi

NCT05270421 | Unknown Phase 3

• 1 other identifier: 21179-01-01-98
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients. The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.

Conditions

Urolithiasis; Nephrolithiasis; Urinary Calculi; Ureterolithiasis

Keywords

Urolithiasis; Nephrolithiasis; ESWL

Outcome Measures

Primary Outcomes (2)

• Stone-free rate

  The absence of a stone ≥ 4 mm

  2 weeks after intervention

• Stone-free rate

  The absence of a stone ≥ 4 mm

  3 months after intervention

Secondary Outcomes (3)

• Renal colic on VAS of 0-10

  24 hours after intervention

• Number of participants with need for re-ESWL

  Within 3 months after intervention

• Number of participants with need for surgery

  Within 3 months after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

40 mg of furosemide IV + IV midazolam + 1000 ml of normal saline 30 minutes before ESWL \+ Standard ESWL

Drug: Furosemide 40 mg; Other: Conventional Treatment

Control Group

ACTIVE COMPARATOR

IV midazolam + 1000 ml of normal saline 30 minutes before ESWL \+ Standard ESWL

Other: Conventional Treatment

Interventions

Furosemide 40 mg DRUG

Standard ESWL + Furosemide 40 mg

Intervention Group

Conventional Treatment OTHER

Standard ESWL

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 60 years
• Patients with renal or ureteral calculi referred by attending urologists to the ESWL Clinic of Shahid Faghihi Hospital, affiliated to Shiraz University of Medical Sciences (Shiraz, Iran)

You may not qualify if:

• An anatomic anomaly in urinary system
• Coagulopathy
• Untreated urinary tract infection
• Prior urologic surgery
• Simultaneous unilateral renal and ureteral stones
• Kidney failure (serum creatinine \> 1.8 mg/dl)
• Cardiovascular disease
• Hypertension
• Morbid obesity (BMI \> 40 kg/m2)
• History of allergy to furosemide, glibenclamide, hydrochlorothiazide, or acetazolamide.
• Pregnancy
• Single kidney

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Shahid Faghihi Hospital

Shiraz, Fars, 71348-14336, Iran

RECRUITING

Related Publications (10)

• Liu Y, Chen Y, Liao B, Luo D, Wang K, Li H, Zeng G. Epidemiology of urolithiasis in Asia. Asian J Urol. 2018 Oct;5(4):205-214. doi: 10.1016/j.ajur.2018.08.007. Epub 2018 Sep 6.

  PMID: 30364478 BACKGROUND

• Safarinejad MR. Adult urolithiasis in a population-based study in Iran: prevalence, incidence, and associated risk factors. Urol Res. 2007 Apr;35(2):73-82. doi: 10.1007/s00240-007-0084-6. Epub 2007 Mar 15.

  PMID: 17361397 BACKGROUND

• Ketabchi AA, Aziziolahi GA. Prevalence of symptomatic urinary calculi in Kerman, Iran. Urol J. 2008 Summer;5(3):156-60.

  PMID: 18825621 BACKGROUND

• Basiri A, Shakhssalim N, Khoshdel AR, Ghahestani SM, Basiri H. The demographic profile of urolithiasis in Iran: a nationwide epidemiologic study. Int Urol Nephrol. 2010 Mar;42(1):119-26. doi: 10.1007/s11255-009-9588-z. Epub 2009 Jun 12.

  PMID: 19521794 BACKGROUND

• Sabharwal S, Jeyaseelan L, Panda A, Gnanaraj L, Kekre NS, Devasia A. A prospective randomised double-blind placebo-controlled trial to assess the effect of diuretics on shockwave lithotripsy of calculi. Arab J Urol. 2017 Jul 8;15(4):289-293. doi: 10.1016/j.aju.2017.04.003. eCollection 2017 Dec.

  PMID: 29234530 BACKGROUND

• Hosseini MM, Shakeri S, Manaheji F, Aminsharifi A, Ezatzadegan S, Pakfetrat M, Basiratnia M, Hosseini M. Stone composition in patients who undergo renal stone surgery: review of 423 stone analyses in southern iran. Iran J Med Sci. 2014 Jan;39(1):75-6. No abstract available.

  PMID: 24453399 BACKGROUND

• McAdams S, Shukla AR. Pediatric extracorporeal shock wave lithotripsy: Predicting successful outcomes. Indian J Urol. 2010 Oct;26(4):544-8. doi: 10.4103/0970-1591.74457.

  PMID: 21369388 BACKGROUND

• Azm TA, Higazy H. Effect of diuresis on extracorporeal shockwave lithotripsy treatment of ureteric calculi. Scand J Urol Nephrol. 2002;36(3):209-12. doi: 10.1080/003655902320131893.

  PMID: 12201937 BACKGROUND

• Zomorrodi A, Golivandan J, Samady J. Effect of diuretics on ureteral stone therapy with extracorporeal shock wave lithotripsy. Saudi J Kidney Dis Transpl. 2008 May;19(3):397-400.

  PMID: 18445899 BACKGROUND

• Sohu S, Soomro MH, Mangrio RH, Shaikh AA, Mirani A, Chand K, Jalbani MH. Efficacy of extracorporeal shockwave lithotripsy with furosemide and hydration in renal stone management: A randomised controlled trial. Arab J Urol. 2019 Jul 24;17(4):279-284. doi: 10.1080/2090598X.2019.1645262. eCollection 2019.

  PMID: 31723445 BACKGROUND

MeSH Terms

Conditions

Urolithiasis; Nephrolithiasis; Urinary Calculi; Ureterolithiasis

Interventions

Furosemide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Dariush Irani, MD

  Department of Urology, School of Medicine, Shiraz University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Seyed Hossein Hosseini, MD

CONTACT

+989177016614; shhosseini_6687@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Using block randomization, the patients are randomly assigned to one of two groups by a statistician outside of the research group. The codes for each group remain unknown to the researchers until after statistical analysis, with only the nurse and physician in charge of delivering the therapy and monitoring the patients being made aware.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 500 patients will be randomly and equally divided into the intervention and control groups.

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 8, 2022
• Study Start: July 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: July 30, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We plan to publish the study protocol within six months.
• Access Criteria: Supporting data will be made available upon reasonable request. All inquiries should be sent to Dr. Seyed Hossein Hosseini.

Locations

IR (1)