Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

Pontificia Universidad Catolica de Chile

Status and phase: Terminated; Phase 4

Conditions: Urolithiasis; Ureteral Calculi; Ureterolithiasis

Treatments: Drug: Tamsulosin Hydrochloride 0.4 milligrams; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03614052

171229002

Details and patient eligibility

About

This a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients.

Full description

Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis.

Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with urolithiasis undergoing to endoscopic ureterolithotomy

Exclusion criteria

• Patients with previous ureteral catheter

  • Patients with allergy to tamsulosin

  • Patients currently in treatment with tamsulosin for other disease different than ureterolithiasis

  • Multiple ureterolithiasis

  • Patients with impairment of their mental status

    • Patients with open surgeries in the affected ureter or urinary diversion
    • Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14 participants in 2 patient groups, including a placebo group

tamsulosin hydrochloride

Experimental group

Description:

Tamsulosin hydrochloride 0,4 mg tablets by mouth per day for 5 days before ureteroscopy

Treatment:

Drug: Tamsulosin Hydrochloride 0.4 milligrams

Placebo oral tablet

Placebo Comparator group

Description:

Placebo oral tablets by mouth per day for 5 days before ureteroscopy

Treatment:

Drug: Placebo Oral Tablet