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Does Tamsulosin Facilitate Semi-rigid Ureteroscopic

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ClinicalTrials.gov Identifier: NCT04602403
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Ahmed Gaber, Assiut University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ureter Stone Procedure: rigid ureteroscopy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : October 15, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo group
people who given placebo to become agroup of comparison with the other group
 Procedure: rigid ureteroscopy
endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser
Other Name: endoscopic treatment of ureteric stone
Active Comparator: tamsulosin group
people who given tamsulosin to know the effect on ureteroscopy and compare with the control group
 Procedure: rigid ureteroscopy
endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser
Other Name: endoscopic treatment of ureteric stone


Outcome Measures
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Primary Outcome Measures :
  1. Rate of patients develop spontaneous expulsion of stone [ Time Frame: up to 3 weeks pre operative ]
    the stone spontaneously expelled without intervension

  2. Number of patients showing dilated ureteric orifice [ Time Frame: intraoperative ]
    during ureteroscopy easy introduction in the ureter

  3. Number of patients need dilatation below stone [ Time Frame: intraoperative ]
    difficult introduce the ureteroscope and reach the stone

  4. Number of patients need dormia extraction or forceps without disintegration [ Time Frame: intraoperative ]
    that is due to dilated ureter so easy remove the stone

  5. Time of operation from introduction of ureteroscope until stone extraction [ Time Frame: intraoperative ]
    to know how easy introduction and expulsion of the ureteroscope


Secondary Outcome Measures :
  1. Rate of patients developed side effect from tamsulosin [ Time Frame: up to 3 weeks pre operative ]
    any side effect from alpha blocker

  2. Rate of patients developed complication [ Time Frame: intraoperative ]
    any compliction during ureteroscopy such as perforation

  3. Number of patients show failure of ureteroscopy [ Time Frame: intraoperative ]
    failed introduction or extraction of stone

  4. Number of patients show residual stone post ureteroscopy [ Time Frame: postoperative 4 weeks ]
    difficulty in expulsion of all stones


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602403


Contacts
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Contact: mahmoud a gaber +201129248656 aboshika52@gmail.com

Locations
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Egypt
Mahmoud Ahmed Gaber Recruiting
Asyūţ, Assiut, Egypt, 71511
Contact: mahmoud a gaber, ph    +201129248656    aboshika52@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: ahmed m abdel hamed Assiut University
More Information
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Responsible Party: Mahmoud Ahmed Gaber, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04602403    
Other Study ID Numbers: tamsulosin and uretroscopy
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Ureteral Diseases
Urologic Diseases
 Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical