Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451061
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2007-03-21
Brief Title:
The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Most of the patients suffering from renal colic have a distal ureterolithiasis It had been demonstrated that α adrenoreceptors antagonists given to patients suffering from renal colic due to distal ureterolithiasis had increased the frequency of stone expulsion rate reduced the time to expulsion and reduced analgesics consumptionMost of the studies evaluated the efficacy of Tamsulosin which is a selective α 1A and α 1D adrenoreceptors antagonistThe lower intramural portion of the ureter where it passes through the detrusor muscle contains mostly α 1D and α 1A adrenergic receptors
Only one study these days describes the use of Alfuzosin which is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor for expulsion of distal ureteric stonesAlfuzosin is a drug with a proven efficacy and considered uroselective with high specificity and sensitivity for the treatment of BPH There was no significant difference in efficacy between the two α blockers Alfuzosin vs Tamsulosin concerning symptoms relief or flow improvement
The objective of this study is to compare patient who would receive the standard treatment for distal ureterolithiasis analgesics Rowatinex to patients who would receive also a non selective α blocker Alfuzosin or a selective α blocker Tamsulosin This in order to evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis
Only one study these days describes the use of Alfuzosin which is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor for expulsion of distal ureteric stonesAlfuzosin is a drug with a proven efficacy and considered uroselective with high specificity and sensitivity for the treatment of BPH There was no significant difference in efficacy between the two α blockers Alfuzosin vs Tamsulosin concerning symptoms relief or flow improvement
The objective of this study is to compare patient who would receive the standard treatment for distal ureterolithiasis analgesics Rowatinex to patients who would receive also a non selective α blocker Alfuzosin or a selective α blocker Tamsulosin This in order to evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis
Detailed Description:
The efficacy of alpha-blockers for expulsion of distal ureteral stones
Urolithiasis is estimated among 8-15 of the population in Europe and North America1-5 Patient who suffer from renal colic represent a very common reason for visiting the emergency room or for hospitalization The stones are usually located in the ureter mostly in its lower third
Some of the distal ureteral stone would pass spontaneously depending on a few factors such as the stones size location shape smooth muscle spasm submucosal edema and anatomy
Since renal colic is one of the most painful conditions the time until expulsion of the stone should be reduced as much as possible In case the stone obstructs and doesnt pass damage to the kidney might occur and surgical intervention should be considered However surgery and anesthesia are not risk free
The local reaction to obstructing ureterolithiasis manifests in ureteric smooth muscle contraction edema inflammation and pain The ureter contains α -adrenergic receptors in the smooth muscle layer along its entire length Since these receptors play an important role in ureteric contraction during renal colic several studies were performed in order to evaluate the effect of α receptors blockade These studies had demonstrated that different α blockers had increased the frequency of stone expulsion rate among patients with renal colic reduced the time to expulsion and reduced analgesics consumption
Most of the studies evaluated the efficacy of Tamsulosin which is a selective α 1A and α 1D adrenoreceptors antagonist The lower intramural portion of the ureter where it passes through the detrusor muscle contains mostly α 1D and α 1A adrenergic receptors
A common treatment these days to obstructive uropathy due to benign prostatic hypertrophy BPH is Alfuzosin Despite the fact that it is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor subtypes it is a drug with a proven efficacy and considered uroselective with high specificity and sensitivity for the treatment of BPH There was no significant difference in efficacy between the two α blockers Alfuzosin vs Tamsulosin concerning symptoms relief or flow improvement and side effects were similar
Only one study these days describes the use of Alfuzosin for expulsion of distal ureteric stones
The objective of this study is to compare patient who would receive the standard treatment for distal ureterolithiasis analgesics Rowatinex to patients who would receive also a non selective α blocker Alfuzosin or a selective α blocker Tamsulosin This in order to evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis
Materials and methods
Participants - Individuals who will be referred to the emergency room or be admitted to the urology department in Soroka hospital Beer-Sheva Israel because of acute renal colic The patient would be considered for the study only if the stone would be located in the distal ureter
This study is estimated to include 120 patients and last 6 months The patients would be divided randomly to three groups
A Patients with renal colic that would receive Abitren and Rowatinex B Same therapy plus Tamsulosin 04 mgdaily C Same therapy as A plus Alfuzosin 10 mgdaily
The treatment would last up to 4 weeks
The duration of the trial would be until expulsion of the stone but not longer than 4 weeks Patients who would not pass the stone spontaneously would be referred to intervention ESWL ureteric stent insertion ureteroscopy
Treatment discontinuation would be due to hospitalization intractable pain fever the need for an intervention
The α blockers treatment would be once daily until stone expulsion or up to four weeks
The initial treatment protocol would be the standard treatment - IV fluids and analgesics
Each patient would be initially evaluated by
physical examination
abdominal radiography
serum creatinine and leukocytes measurement
urinalysis
renal ultrasonography
blood pressure measurement
The follow up
The blood pressure measurements would be taken by the family physician two days and one week after the beginning of the treatment Four weeks after the treatment begins each patient would be checked in the out patient clinic Unenhanced CT scan serum creatinine and blood pressure measurement would be taken In case the patient would not pass the stone intervention would be scheduled
Urolithiasis is estimated among 8-15 of the population in Europe and North America1-5 Patient who suffer from renal colic represent a very common reason for visiting the emergency room or for hospitalization The stones are usually located in the ureter mostly in its lower third
Some of the distal ureteral stone would pass spontaneously depending on a few factors such as the stones size location shape smooth muscle spasm submucosal edema and anatomy
Since renal colic is one of the most painful conditions the time until expulsion of the stone should be reduced as much as possible In case the stone obstructs and doesnt pass damage to the kidney might occur and surgical intervention should be considered However surgery and anesthesia are not risk free
The local reaction to obstructing ureterolithiasis manifests in ureteric smooth muscle contraction edema inflammation and pain The ureter contains α -adrenergic receptors in the smooth muscle layer along its entire length Since these receptors play an important role in ureteric contraction during renal colic several studies were performed in order to evaluate the effect of α receptors blockade These studies had demonstrated that different α blockers had increased the frequency of stone expulsion rate among patients with renal colic reduced the time to expulsion and reduced analgesics consumption
Most of the studies evaluated the efficacy of Tamsulosin which is a selective α 1A and α 1D adrenoreceptors antagonist The lower intramural portion of the ureter where it passes through the detrusor muscle contains mostly α 1D and α 1A adrenergic receptors
A common treatment these days to obstructive uropathy due to benign prostatic hypertrophy BPH is Alfuzosin Despite the fact that it is an α adrenergic receptor blocker and not selective for any α 1 adrenergic receptor subtypes it is a drug with a proven efficacy and considered uroselective with high specificity and sensitivity for the treatment of BPH There was no significant difference in efficacy between the two α blockers Alfuzosin vs Tamsulosin concerning symptoms relief or flow improvement and side effects were similar
Only one study these days describes the use of Alfuzosin for expulsion of distal ureteric stones
The objective of this study is to compare patient who would receive the standard treatment for distal ureterolithiasis analgesics Rowatinex to patients who would receive also a non selective α blocker Alfuzosin or a selective α blocker Tamsulosin This in order to evaluate the efficacy of treatment with α blockers for expulsion of distal ureterolithiasis
Materials and methods
Participants - Individuals who will be referred to the emergency room or be admitted to the urology department in Soroka hospital Beer-Sheva Israel because of acute renal colic The patient would be considered for the study only if the stone would be located in the distal ureter
This study is estimated to include 120 patients and last 6 months The patients would be divided randomly to three groups
A Patients with renal colic that would receive Abitren and Rowatinex B Same therapy plus Tamsulosin 04 mgdaily C Same therapy as A plus Alfuzosin 10 mgdaily
The treatment would last up to 4 weeks
The duration of the trial would be until expulsion of the stone but not longer than 4 weeks Patients who would not pass the stone spontaneously would be referred to intervention ESWL ureteric stent insertion ureteroscopy
Treatment discontinuation would be due to hospitalization intractable pain fever the need for an intervention
The α blockers treatment would be once daily until stone expulsion or up to four weeks
The initial treatment protocol would be the standard treatment - IV fluids and analgesics
Each patient would be initially evaluated by
physical examination
abdominal radiography
serum creatinine and leukocytes measurement
urinalysis
renal ultrasonography
blood pressure measurement
The follow up
The blood pressure measurements would be taken by the family physician two days and one week after the beginning of the treatment Four weeks after the treatment begins each patient would be checked in the out patient clinic Unenhanced CT scan serum creatinine and blood pressure measurement would be taken In case the patient would not pass the stone intervention would be scheduled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None