Medical therapy after shock wave lithotripsy

Phase 3

Withdrawn

Conditions: Medical expulsive therapy using diuretics and alpha-blockers after shock wave lithotripsy of kidney stones

Registration Number: 2024-510792-38-01

Lead Sponsor: Region Midtjylland

Brief Summary: We would like to evaluate the effect of combined alpha-blocker (Tamsulosin) and diuretic (Furosemid) in respect to clearance of stone fragments following ESWL. Our hypothesis is that a supplement of Tamsulosin along with Furosemid will increase the effectivity of the treatment. It will thereby reduce the number of ESWL treatments and will reduce pain intensity and the need for pain medication after ESWL.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not authorised

Sex: Not specified

Target Recruitment: 420

Inclusion Criteria

• Patients with kidney and proximally located ureteral stones with diameter < 2 cm • Patients >18 years • Able to understand the study procedures and willing to provide signed informed consent

Exclusion Criteria

• Symptoms of urinary tract infection • Ureteral or nephrostomy stent placement prior to the intervention • Multiple stones • Renal functional deterioration • Severe hydronephrosis • Hypotension • Solitary kidney • Ectopic kidney and other anatomical anomalies • Patients have other disorders such as heart disease, kidney failure • Positive pregnancy test or fertile women without safety contraception • Allergy to one of the ingredients in the trial medicine

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Stone clearance: A stone-free condition is defined as the complete absence of any stone or the presence of residual fragments smaller than 3 mm in diameter and should be evaluated 4 weeks after last treatment with Non-contrast CT.		• Stone clearance: A stone-free condition is defined as the complete absence of any stone or the presence of residual fragments smaller than 3 mm in diameter and should be evaluated 4 weeks after last treatment with Non-contrast CT.

Secondary Outcome Measures

Name	Time	Method
Clinical outcomes and success as measured in terms of stone-free rate after ESWL is strongly correlated to pain experienced during and after the treatment. The secondary outcomes will be: • Compare pain during and post ESWL period using a validated VAS. Combination of the two types of medicine is going to be evaluated on the degree of the pain relief. The intensity of their pain will be assessed in three phases; • During the two sessions of ESWL and 2 weeks after the last procedure.		Clinical outcomes and success as measured in terms of stone-free rate after ESWL is strongly correlated to pain experienced during and after the treatment. The secondary outcomes will be: • Compare pain during and post ESWL period using a validated VAS. Combination of the two types of medicine is going to be evaluated on the degree of the pain relief. The intensity of their pain will be assessed in three phases; • During the two sessions of ESWL and 2 weeks after the last procedure.

Trial Locations

Locations (1): Region Midtjylland
🇩🇰
Herning, Denmark
Region Midtjylland
🇩🇰Herning, Denmark
Sukru Oguzkan Topcu
Site contact
+4560884348
sukru.topcu@viborg.rm.dk