Does Tamsulosin Facilitate Semi-rigid Ureteroscopic

NCT ID: NCT04602403

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-10-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ureter Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo group

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

Group Type PLACEBO_COMPARATOR

rigid ureteroscopy

Intervention Type PROCEDURE

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

tamsulosin group

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

Group Type ACTIVE_COMPARATOR

rigid ureteroscopy

Intervention Type PROCEDURE

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

Interventions

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rigid ureteroscopy

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

Intervention Type PROCEDURE

Other Intervention Names

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endoscopic treatment of ureteric stone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Ahmed Gaber

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed m abdel hamed

Role: STUDY_DIRECTOR

Assiut University

Locations

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Mahmoud Ahmed Gaber

Asyut, Asyut Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mahmoud a gaber

Role: CONTACT

+201129248656

Facility Contacts

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mahmoud a gaber, ph

Role: primary

+201129248656

Other Identifiers

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tamsulosin and uretroscopy

Identifier Type: -

Identifier Source: org_study_id