Does Tamsulosin Facilitate Semi-rigid Ureteroscopic
- Conditions
- Ureter Stone
- Interventions
- Procedure: rigid ureteroscopy
- Registration Number
- NCT04602403
- Lead Sponsor
- Assiut University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Lower ureteral stone.
- Age: 18 - 75 years.
- normal renal function.
- single sided ureteral stone with normal other kideny.
- sign the informed consent.
- Be willing/able to adhere to follow up visits.
- Upper and middle ureteral stones.
- renal impairment.
- Age < 18 years or 75 < years.
- female who were pregnant
- bilateral ureteric stone or solitary kidney.
- urinary tract infection need drainage.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tamsulosin group rigid ureteroscopy people who given tamsulosin to know the effect on ureteroscopy and compare with the control group placebo group rigid ureteroscopy people who given placebo to become agroup of comparison with the other group
- Primary Outcome Measures
Name Time Method Number of patients need dilatation below stone intraoperative difficult introduce the ureteroscope and reach the stone
Number of patients showing dilated ureteric orifice intraoperative during ureteroscopy easy introduction in the ureter
Rate of patients develop spontaneous expulsion of stone up to 3 weeks pre operative the stone spontaneously expelled without intervension
Number of patients need dormia extraction or forceps without disintegration intraoperative that is due to dilated ureter so easy remove the stone
Time of operation from introduction of ureteroscope until stone extraction intraoperative to know how easy introduction and expulsion of the ureteroscope
- Secondary Outcome Measures
Name Time Method Rate of patients developed side effect from tamsulosin up to 3 weeks pre operative any side effect from alpha blocker
Rate of patients developed complication intraoperative any compliction during ureteroscopy such as perforation
Number of patients show residual stone post ureteroscopy postoperative 4 weeks difficulty in expulsion of all stones
Number of patients show failure of ureteroscopy intraoperative failed introduction or extraction of stone
Trial Locations
- Locations (1)
Mahmoud Ahmed Gaber
🇪🇬Asyūţ, Assiut, Egypt