Does Tamsulosin Facilitate Semi-rigid Ureteroscopic

NCT04602403 | Unknown DMC

• 1 other identifier: tamsulosin and uretroscopy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureter Stone

Outcome Measures

Primary Outcomes (5)

• Rate of patients develop spontaneous expulsion of stone

  the stone spontaneously expelled without intervension

  up to 3 weeks pre operative

• Number of patients showing dilated ureteric orifice

  during ureteroscopy easy introduction in the ureter

  intraoperative

• Number of patients need dilatation below stone

  difficult introduce the ureteroscope and reach the stone

  intraoperative

• Number of patients need dormia extraction or forceps without disintegration

  that is due to dilated ureter so easy remove the stone

  intraoperative

• Time of operation from introduction of ureteroscope until stone extraction

  to know how easy introduction and expulsion of the ureteroscope

  intraoperative

Secondary Outcomes (4)

• Rate of patients developed side effect from tamsulosin

  up to 3 weeks pre operative

• Rate of patients developed complication

  intraoperative

• Number of patients show failure of ureteroscopy

  intraoperative

• Number of patients show residual stone post ureteroscopy

  postoperative 4 weeks

Study Arms (2)

placebo group

PLACEBO COMPARATOR

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

Procedure: rigid ureteroscopy

tamsulosin group

ACTIVE COMPARATOR

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

Procedure: rigid ureteroscopy

Interventions

rigid ureteroscopy PROCEDURE

endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser

Also known as: endoscopic treatment of ureteric stone

placebo group; tamsulosin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Mahmoud Ahmed Gaber

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• ahmed m abdel hamed

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

mahmoud a gaber

CONTACT

+201129248656; aboshika52@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 26, 2020
• Study Start: October 15, 2020
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

EG (1)