How does tamsulosin help with kidney stones

Time limit is exhausted. All rights reserved. Disclaimer Website by Innov8 Place. June 29, These interventions were mostly based on poor methodologic studies and meta-analyses of these flawed studies Hollingsworth Over the past years, a small number of higher-quality RCTs have been published Ferre , Pickard , Furyk Outcomes: Primary: Stone passage based on visualization or capture by day 28 Secondary: Stone passed on follow up CT scan, Crossover to open-label tamsulosin, time to stone passage, return to work, use of analgesic medication, hospitalization, surgical intervention and repeated ED visit for urinary stones Intervention: Tamsulosin 0.

More patients in the placebo arm had multiple stones, more patients in the tamsulosin arm had distal ureteral stones Patients lost to follow up were excluded from the analysis. Instead, investigators could have included them with outcomes matching the null-hypothesis Target absolute difference may have been set too high.

A smaller but still clinically important difference may still be possible Self-reported adherence to study medication was Ye It is important to note that the idea that larger stones will benefit is based on secondary and exploratory analyses only.

Additionally, the Ye article is limited as only distal ureteral stones were included. A RDCT primarily examining larger stones is needed. This would increase radiation exposure and resource utilization with only a small portion of patients benefiting. Alpha blockers for treatment of ureteric stones: systematic review and meta-analysis. Citrate therapy also stabilizes existing stones and decreases the need for retreatment. These benefits come at the expense of upper gastrointestinal disturbances that lead to a higher dropout rate.

Tamsulosin promotes stone passage of distal ureteral stones that are 5 to 10 mm in size. You would need to treat five such patients to get one stone passage.

This is a good example of how a well-done study can lead to erroneous conclusions. The comparator most likely to be effective here—titrated morphine—was used at a low dose and found to be less effective than intramuscular diclofenac or intravenous paracetamol acetaminophen. Four hundred ninety-seven patients were evaluated for the primary outcome.

None of the secondary outcomes were significantly different. All analyses were performed according to the intention-to-treat principle, although patients lost to follow-up before stone passage were excluded from the analysis of final outcome. Conclusions and Relevance Tamsulosin did not significantly increase the stone passage rate compared with placebo. Our findings do not support the use of tamsulosin for symptomatic urinary stones smaller than 9 mm.

Guidelines for medical expulsive therapy for urinary stones may need to be revised. Trial Registration ClinicalTrials. This first phase allowed an assessment of the feasibility of recruitment and provided the opportunity to determine the rate of stone passage in the placebo group to revise our original estimate of the sample size for the trial.

The primary outcome was not analyzed at the end of phase 1. The second phase of the study was conducted from to at 6 emergency department recruiting sites, including the original site in phase 1. The data from participants enrolled in both phases were analyzed together. Both protocols were approved by the institutional review boards of the participating institution or institutions.

The study was registered at ClinicalTrials. SAS software version 9. Adults at least 18 years of age were eligible for the study if they presented to the emergency department with a symptomatic urinary stone determined by computed tomography CT to be less than 9 mm in diameter and located in the ureter. At each participating emergency department patients with a CT-confirmed ureteral stone were screened for eligibility during study enrollment hours approximately hours per week at each site.

The initial CT imaging was ordered as part of normal clinical care for emergency department patients with symptoms suggestive of renal colic. For patients determined to have multiple stones, one ureteral stone had to be identified as the symptomatic stone by the site principal investigator to be eligible. Full eligibility criteria for the study have been previously published in detail. Eligible patients were randomized to either tamsulosin at a dose of 0.

Both treatments consisted of identically encapsulated pills with identical packaging 1 bottle with 30 capsules per patient. Neither the participant nor the study staff knew to which group the participant was randomized. The randomization sequence was generated using the simple urn method, stratified by site.

Study participants enrolled in the second phase were also asked to undergo a follow-up CT scan after the day treatment period to determine whether their stone had passed based on this imaging modality.

Patients who had already received a second CT outside the study protocol with a confirmed passage of their stone were not asked to return for a follow-up CT. Secondary outcomes included an assessment of urinary stone passage, as determined by a follow-up CT scan after 28 days second phase only ; the number of participants who discontinued their assigned study medication and crossed over to open-label tamsulosin; the proportion of participants who returned to work; the rate of surgical procedures including lithotripsy ; the rate of hospitalization; the percentage who returned to the emergency department for ureteral stone—related symptoms; and the duration of pain defined by the time until participants reported stopping use of analgesic medication or the time to stone passage.

An outcome review committee composed of 3 urologists P. This committee was required to agree unanimously whether the symptomatic stone had passed and created an algorithm for categorizing the results as follows: In cases when stones were either not visualized or there were no stones on the symptomatic side, the participant was considered to have passed the stone. When the symptomatic stone was at the same location or lower in the ureter than the initial symptomatic stone, participants were considered not to have passed their stone.

In the 11 cases for which this algorithm did not yield a clear result, the CT scans were individually reviewed and a consensus was reached. Based on the placebo passage rate from the first phase of the study, the original target sample size of per treatment group was maintained.

Since only the passage rate in the placebo group of phase 1 data was obtained, the phase 1 participants were included in the overall sample. As a result, the final critical value for the primary outcome was adjusted, and a 2-tailed P value of less than.

For the primary outcome, we thus report a The primary outcome analysis was also adjusted for imbalances in baseline characteristics of the participants and recruitment sites using logistic regression. Continuous variables were compared using the Wilcoxon test. The time to stone passage and time to pain relief were analyzed using Kaplan-Meier survival curves and log-rank tests. For all secondary outcomes, a nominal P value of less than. The location of a stone in the lower ureter was defined as one found in either the distal ureter below the level of the sacroiliac vessels or the ureterovesical junction; those found in the upper ureter were located either in the renal pelvis, ureteropelvic junction, proximal ureter, or mid-ureter.

We randomized participants overall Figure : in the first phase and in the second phase. Their mean SD age was Symptomatic stones were most frequently observed either in the ureterovesical junction, One hundred ninety-six of the participants The mean SD diameter of the symptomatic urinary stone was 3. The baseline clinical and demographic characteristics of the 2 treatment groups were similar Table 1 except for age At the end of the day treatment period, the urinary stone passage rate of After adjusting for age and recruiting site, the difference between the urinary stone passage rates remained nonsignificant relative risk, 1.

The rates of treatment-related adverse effects were similar between treatment groups for the participants in phase 2 who had any contact after randomization, with the exception of increased ejaculatory dysfunction among men in the tamsulosin group Table 3. No serious adverse events were reported. Although there was a 6. Similarly, there was no difference between treatment groups for any of the secondary outcomes, including the number of participants who crossed over to open-label tamsulosin, the proportion of participants who returned to work within 28 days of enrollment, rate of surgery, rate of hospitalization, or return to the emergency department for urinary stones Table 2.

Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Kidney Stone. Drug: Flowmax Drug: placebo. Not Applicable. Study Type :.

Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :.