Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

NCT00209131 | Terminated Results

• 1 other identifier: 0128-2005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Conditions

Urolithiasis

Keywords

urolithiasis

Outcome Measures

Primary Outcomes (1)

• Time to Passage of Stone Fragments

  Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.

  2 weeks and 3 months

Secondary Outcomes (1)

• Medical Evaluation

  2 weeks and 3 months

Study Arms (2)

Flomax

EXPERIMENTAL

Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.

Drug: Flomax

Sugar pill

PLACEBO COMPARATOR

Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.

Drug: Sugar pill

Interventions

Flomax DRUG

0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.

Also known as: Tamsulosin

Flomax

Sugar pill DRUG

Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.

Also known as: Placebo pill

Sugar pill

Eligibility Criteria

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

You may qualify if:

• Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.

You may not qualify if:

• Contraindications to Flomax
• Patients with renal impairment (serum creatinine above 2.0)
• Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)
• Use of other oral alpha blockers

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Tamsulosin; Sugars

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study was terminated due to turnovers of personnel to assist with recruitment and execution of the study.Recruitment was strained and patients recruited could not be followed up in a timely fashion to adhere to protocol. Thus, no data was generated.

Results Point of Contact

• Title: Dr. Kenneth Ogan
• Organization: Emory University

kogan@emory.edu

404-778-4898

Study Officials

• Kenneth Ogan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 28, 2013
• Results First Posted: July 9, 2012

Record last verified: 2013-09

Locations

US (1)