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Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.
Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.
Ureteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.
Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo group | Placebo Comparator | people who given placebo to become agroup of comparison with the other group |
|
| tamsulosin group | Active Comparator | people who given tamsulosin to know the effect on ureteroscopy and compare with the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rigid ureteroscopy | Procedure | endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients develop spontaneous expulsion of stone | the stone spontaneously expelled without intervension | up to 3 weeks pre operative |
| Number of patients showing dilated ureteric orifice | during ureteroscopy easy introduction in the ureter | intraoperative |
| Number of patients need dilatation below stone | difficult introduce the ureteroscope and reach the stone | intraoperative |
| Number of patients need dormia extraction or forceps without disintegration | that is due to dilated ureter so easy remove the stone | intraoperative |
| Time of operation from introduction of ureteroscope until stone extraction | to know how easy introduction and expulsion of the ureteroscope | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients developed side effect from tamsulosin | any side effect from alpha blocker | up to 3 weeks pre operative |
| Rate of patients developed complication | any compliction during ureteroscopy such as perforation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mahmoud a gaber | Contact | +201129248656 | aboshika52@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ahmed m abdel hamed | Assiut University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahmoud Ahmed Gaber | Recruiting | Asyut | Asyut Governorate | 71511 | Egypt |
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| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| intraoperative |
| Number of patients show failure of ureteroscopy | failed introduction or extraction of stone | intraoperative |
| Number of patients show residual stone post ureteroscopy | difficulty in expulsion of all stones | postoperative 4 weeks |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |