The Efficacy and Safety of Adjunctive Alpha-blocker Therapy Before Flexible Ureteroscopy in the Management of Upper Ureteric Stones in Pediatrics Group

NCT07841340 | Completed DMC

• 1 other identifier: FMASU MS569/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A unique aspect of pediatric URS is the smaller ureteral diameter, which often results in failure to access the ureter during an initial URS attempt. Ureteral orifice navigation is often limited at the level of the ureteral orifice or intramural ureter. α1 adrenergic receptors are densely located at this level, and α-antagonists can reduce the tension of the intramural segment The purpose of this study was to evaluate if preoperative treatment with tamsulosin is associated with an increased rate of successful first-time ureteral orifice navigation in a school-age pediatric population, defined as patients 5-18 years old.

Conditions

Paediatric; Flexible Ureteroscopy

Keywords

paediatric; alpha blocker; flexible ureteroscopy; tamsulosin

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Successful Flexible Ureteroscope Negotiation Through the Ureteral Orifice in tamsulosin group versus non tamsulosin group

  Successful negotiation is defined as advancement of the flexible ureteroscope through the ureteral orifice and into the ureter sufficiently to allow performance of the intended ureteroscopic procedure. The outcome will be recorded as the number and percentage of participants with successful negotiation in each treatment group

  Intraoperative, during flexible ureteroscopy

Secondary Outcomes (2)

• Number of Participants with Intraoperative or Postoperative Complications Following Flexible Ureteroscopy

  From the beginning of flexible ureteroscopy until 1 month postoperatively

• Number of Participants with Tamsulosin-Related Adverse Events Following Preoperative Tamsulosin Administration.

  From initiation of tamsulosin until the day of surgery

Study Arms (2)

interventional

EXPERIMENTAL

Children with ureteric stones with age between 5:18 years will receive Tamsulosin 0.4 mg capsule for 5 days prior to Flexible uretroscopy

Drug: Tamsulosin

control

NO INTERVENTION

Children with ureteric stones with age between 5:18 years will not receive Tamsulosin 0.4 mg capsule prior to Flexible uretroscopy

Interventions

Tamsulosin DRUG

Children will receive Tamsulosin 0.4 mg ( alpha blocker) capsule for 5 days prior to Flexible uretroscopy

interventional

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 5:18 years
• Children with upper ureteric stones

You may not qualify if:

• Children with active urosepsis.
• Children with ureteral stricture
• Children with past history of ureteric endoscopy or stent application.
• Children with bilateral ureteral stones.
• Children with congenital anomalies e.g. solitary kidney, duplex system, ureterocele.
• Those with hypersensitivity to α-blockers.
• Known hypotensive or bradycardic patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams university

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children with ureteric stones ranging from 5-10 mm Age between 5:18 years

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 25, 2026
• Study Start: September 4, 2022
• Primary Completion: April 4, 2023
• Study Completion: September 1, 2024
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

EG (1)