Clinical trial NCT06999135: Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones
Official title: Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tamsulosin
Silodosin
Medical Expulsive Therapy
Lead sponsor: Fatima Jinnah Medical University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness and side effect profiles of Tamsulosin and Silodosin in medical expulsive therapy (MET) for ureteric stones. Conducted as a randomized control trial at Sir Ganga Ram Hospital, Lahore, 180 patients were analyzed-89 on Tamsulosin and 93 on Silodosin. Results showed that Silodosin had a higher stone expulsion rate, especially within 14 days, and fewer side effects compared to Tamsulosin. Common side effects included orthostatic hypotension, abnormal ejaculation, and headaches, with Silodosin showing a better overall safety profile.

Detailed description: This study was designed as a prospective, randomized, open-label, controlled trial conducted at the Urology Department of Sir Ganga Ram Hospital, Lahore, over a period of 12 months. Ethical approval was obtained from the institutional review board, and written informed consent was secured from all participants.

Participants included adults aged 18 to 60 years with a single, unilateral ureteric stone measuring 5 to 10 mm, confirmed by non-contrast CT scan. Patients with a history of ureteral surgery, congenital anomalies, severe renal impairment (serum creatinine above 1.5 mg/dL), pregnancy, lactation, urinary tract infection, or those using calcium channel blockers or other alpha-blockers were excluded. A total of 180 eligible patients were randomized into two groups: 89 patients received Tamsulosin 0.4 mg daily, while 93 patients received Silodosin 8 mg daily.

Both groups received standard analgesia with diclofenac sodium 50 mg as needed and were advised to maintain adequate hydration. Treatment continued until stone expulsion or for a maximum of 28 days. Patients were monitored weekly through clinical evaluation and imaging (ultrasound or X-ray), and adverse events such as dizziness, ejaculatory dysfunction, and headaches were recorded using standardized questionnaires.

Data analysis was performed using SPSS version 25.0. Continuous variables were compared using Student's t-test, while categorical variables were assessed with Chi-square or Fisher's exact test. A p-value of less than 0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Patients between ages 18 years - 55 years.
* Solitary unilateral ureteral stone
* Stone sizes less than 10 mm measured on non-contrast computed tomography of kidney, ureter and bladder.
* Stones being treated primarily with medical expulsive therapy
* Radio opaque Stone

Exclusion Criteria:

* Pregnancy
* Untreated UTI
* Bleeding disorders
* Obstruction distal to stone
* Serum Creatinine \> 1.3 mg/dl in males and \> 1.2 mg/dl in females.
* Congenital renal anomaly/ skeletal malformation
* Previous treatment for the same stone (PCNL/ URS / push back)
* Solitary Kidney
* Prior JJ stent insertion
* Bilateral ureteral stone

Primary outcomes:
measure: STONE EXPULSION RATE
timeFrame: 6 MONTHS
measure: TIME TO STONE EXPULSION
timeFrame: 6MONTHS
Secondary outcomes:
measure: INCIDENCE OF ORTHOSTATIC HYPOTENSION
timeFrame: 6 months
measure: Incidence of Abnormal Ejaculation
timeFrame: 6 months
measure: Incidence of Headache Percentage of patients reporting headaches, assessed via patient questionnaires.
timeFrame: 6 months
measure: Analgesic Requirement:
timeFrame: 6 months
measure: Need for Auxiliary Procedures
timeFrame: 6 months
measure: Stone Position and Laterality
timeFrame: 6 months
measure: Symptom Duration Prior to CT:
timeFrame: 6 months
Other outcomes:
measure: BMI
timeFrame: 6 MONTHS
Locations:
city: Lahore
country: Pakistan
facility: Fatima Jinnah Medical University
state: Punjab
Study officials:
affiliation: FATIMA JINNAH MEDICAL UNIVERSITY LAHORE
name: PROF MUNIZA QAYYUM, PHD PHARMACOLOGY
role: STUDY_CHAIR
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