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To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
Objective: To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
Patients and Methods: A randomized control trial was conducted at two high volume urological centers from September 2017 to December 2018. We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively |
|
| Group B | Placebo Comparator | 62 patients who underwent non-stented ureteroscopy and laser and received placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin Oral Capsule | Drug | To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones. |
| Measure | Description | Time Frame |
|---|---|---|
| Need for dilatation | ( to evaluate whether the ureteroscope will pass easily through the ureter if not , serial ureteric dilatation will be done and documented ) it is a yes or no evaluation | intraoperative assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Time of operation (min) | duration of the procedure in minutes | intraoperative assessment |
| Lower urinary tract symptoms "LUTs" | (frequency, urgency and dysuria) (Yes/NO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology department - ain shams university | Cairo | 11361 | Egypt |
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We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.
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patients were blinded to the type of intervention, as well as the data collector
| Placebo | Drug | Placebo - control group |
|
| early postoperative period ( 2 weeks) |
| Need for analgesia | need for analgesics for postoperative pain according to the numeric rating scale (yes/no) | first day postoperative |
| Gross Hematuria | post operative hematuria (present or not ) | first day postoperative |
| Fever | elevated body temperature post operative in degree Celsius | early postoperative (2 weeks) |
| hospital stay | duration in hours | from few hours up to 2 days postoperative |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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