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NCT Number: NCT04557202

Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones: A Randomized Controlled Trial

To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.

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Key information

Conditions

Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Urology department - ain shams university

Cairo, 11361, Egypt

About this study

Objective: To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.

Patients and Methods: A randomized control trial was conducted at two high volume urological centers from September 2017 to December 2018. We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with single lower ureteric stones of size range between 0.5 and 2 cm

Exclusion criteria

  • Patients under the age of 18, pregnant women, or those with urinary tract infections, uncorrected bleeding disorders or coagulopathies, bilateral ureteric stones, single kidney, ureteral stricture, multiple ipsilateral ureteric stones were excluded from our study. Also, any patients who required ureteric stenting were excluded from our study.

Treatment and study plan

Tamsulosin Oral Capsule

Drug

To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.

Placebo

Drug

Placebo - control group

Primary outcomes

  1. Need for dilatation

    Time frame: intraoperative assessment

    ( to evaluate whether the ureteroscope will pass easily through the ureter if not , serial ureteric dilatation will be done and documented ) it is a yes or no evaluation

Secondary outcomes

  1. Time of operation (min)

    Time frame: intraoperative assessment

    duration of the procedure in minutes

  2. Lower urinary tract symptoms "LUTs"

    Time frame: early postoperative period ( 2 weeks)

    (frequency, urgency and dysuria) (Yes/NO)

  3. Need for analgesia

    Time frame: first day postoperative

    need for analgesics for postoperative pain according to the numeric rating scale (yes/no)

  4. Gross Hematuria

    Time frame: first day postoperative

    post operative hematuria (present or not )

  5. Fever

    Time frame: early postoperative (2 weeks)

    elevated body temperature post operative in degree Celsius

  6. hospital stay

    Time frame: from few hours up to 2 days postoperative

    duration in hours

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2020
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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