Does Tamsulosin Facilitate Semi-rigid Ureteroscopic

Assiut University

Status: Unknown

Conditions: Ureter Stone

Treatments: Procedure: rigid ureteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04602403

tamsulosin and uretroscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

people who given placebo to become agroup of comparison with the other group

Treatment:

Procedure: rigid ureteroscopy

tamsulosin group

Active Comparator group

Description:

people who given tamsulosin to know the effect on ureteroscopy and compare with the control group

Treatment:

Procedure: rigid ureteroscopy