Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi

NCT05977647 | Completed Phase 4

• 1 other identifier: GTZ-MSE-001-23
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

As a first treatment option for small-size ureteric stones, α-blockers are now being used for medical expulsive therapy (MET) instead of invasive procedures. There is high evidence of the therapeutic benefit of α-blockers in the treatment of Distal ureteric stone (DUS); also endorsed by international guidelines. However, limited data is available worldwide, on the effect of silodosin to treat DUS. A multi-center study is needed to confirm the efficacy and safety of therapy.

Conditions

Ureteric Stone of Lower Third of Ureter

Outcome Measures

Primary Outcomes (1)

• % of stone expulsion

  The primary outcome measure will be the passage of stone expulsion self-reported definitive passage of calculus or the first day of pain-free to 48 hours period with calculus absent of X - ray KUB.

  4 weeks

Secondary Outcomes (6)

• Time in days to stone expulsion

  4 weeks

• Frequency of pain reported by patients

  4 weeks

• Change in intensity of pain

  4 weeks

• Usage of analgesics

  4 weeks

• Frequency of ER visits

  4 weeks

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

Patients with lower ureteric stone will be randomized through permuted block randomization equally into two group. 120 patients will be on tamsulosin 0.4 mg once daily, therapy will be given for a maximum of 4 weeks.

Drug: Tamsulosin Oral Capsule

Silodosin

ACTIVE COMPARATOR

Patients with lower ureteric stone will be randomized through permuted block randomization equally into two group. 120 patients will be on Silodosin 8 mg once daily. Therapy will be given for a maximum of 4 weeks.

Drug: Tamsulosin Oral Capsule

Interventions

Tamsulosin Oral Capsule DRUG

Patient will be enrolled in one of study arm through randomization.

Also known as: silodosin Oral Capsule

Silodosin; Tamsulosin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults male and female aged 18 to 70 years
• Patients who give informed consent
• Stone located in the distal 1/3rd of ureter (Single, unilateral and radiopaque ureteral calculus 5 to 10 mm visible on the CT-KUB± X-ray KUB within the ureter
• Serum creatinine level within the normal range (adult men, 0.74 to 1.35 mg/dL \& 0.59 to 1.04 mg/dL)
• Ability to tolerate oral fluids and oral pain medication

You may not qualify if:

• Patients already taking an alpha-adrenergic antagonist medication for 4 weeks
• Evidence of any other renal stone simultaneously present or at any location
• Hydronephrosis Grade 3 (Moderate) \& Grade 4 (Severe) Patients with eGFR \<60 ml/min/1.73m2
• Signs of infection including temperature \>38ºC or Urinalysis with any of the following: Positive Leukocyte Esterase, Positive Nitrates, or White Blood Cell Count \>5/hfp in the setting of a positive urine culture (defined as a single isolated bacterial species population of \>100,000 CFU)
• Patients with chronic pain already undergoing treatment with narcotic medications or drug abusers
• Pregnant or lactating women
• Patient suffering from urinary tract infection, ureteral surgery, and existing DJ stents.
• Clinical jaundice
• Any forms of anatomical obstructions in the urinary tract
• The previously suffering from postural hypotension
• Any other disease jeopardizing participation in trial and could lead to increase patient health risks
• History of allergic reactions with the study drugs (Silodosin or Tamsulosin)

Sponsors & Collaborators

• Getz Pharma: lead

Study Sites (1)

North west general hospital

Peshawar, KPK, Pakistan

Location

MeSH Terms

Interventions

Tamsulosin; silodosin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Salman El Khalid, MBBS

  The Kidney Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into two groups. 1. A permuted block randomization technique will be used 2. A block represents a separate center/site of enrollment. 3. There will be 19 recruitment centers 4. Each center will enroll total 20-25 subjects

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 4, 2023
• Study Start: September 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)