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

NCT04557202 | Completed Phase 3 DMC

• 1 other identifier: fwa00001989
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones

Keywords

Uretroscopic lithotripsy; non-stented; alpha1-blocker; LUTS; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Need for dilatation

  ( 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

  intraoperative assessment

Secondary Outcomes (6)

• Time of operation (min)

  intraoperative assessment

• Lower urinary tract symptoms "LUTs"

  early postoperative period ( 2 weeks)

• Need for analgesia

  first day postoperative

• Gross Hematuria

  first day postoperative

• Fever

  early postoperative (2 weeks)

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Tamsulosin Oral Capsule

Group B

PLACEBO COMPARATOR

62 patients who underwent non-stented ureteroscopy and laser and received placebo.

Drug: Placebo

Interventions

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.

Group A

Placebo DRUG

Placebo - control group

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Urology department - ain shams university

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients were blinded to the type of intervention, as well as the data collector
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of Urology - ain shams university

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 21, 2020
• Study Start: September 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

EG (1)