Clinical trial NCT04602403: Does Tamsulosin Facilitate Semi-rigid Ureteroscopic
Official title: Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ureter Stone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of patients develop spontaneous expulsion of stone
timeFrame: up to 3 weeks pre operative
measure: Number of patients showing dilated ureteric orifice
timeFrame: intraoperative
measure: Number of patients need dilatation below stone
timeFrame: intraoperative
measure: Number of patients need dormia extraction or forceps without disintegration
timeFrame: intraoperative
measure: Time of operation from introduction of ureteroscope until stone extraction
timeFrame: intraoperative
Secondary outcomes:
measure: Rate of patients developed side effect from tamsulosin
timeFrame: up to 3 weeks pre operative
measure: Rate of patients developed complication
timeFrame: intraoperative
measure: Number of patients show failure of ureteroscopy
timeFrame: intraoperative
measure: Number of patients show residual stone post ureteroscopy
timeFrame: postoperative 4 weeks
Other outcomes:
Locations:
city: Asyūţ
country: Egypt
facility: Mahmoud Ahmed Gaber
state: Assiut
Study officials:
affiliation: Assiut University
name: ahmed m abdel hamed
role: STUDY_DIRECTOR
References: