Effectiveness of Silodosin versus Tadalafil as medical expulsive therapy for lower ureteric calculi - A Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Effectiveness of Silodosin versus Tadalafil as medical expulsive therapy for lower ureteric calculi
Study Overview
Brief Summary
After correction from the IRC&IEC, convenient sampling of patients attending opd services
during the study period mentioned, fulfilling the inclusion and exclusion criteria as listed will be
recruited for the study, after obtaining informed written consent under the guidance of the guide and
co-guide.
The nature, purpose and their roles in the study will be explained in detail, including the information
that their non-participation in the study would not affect the quality of their treatment that they are to receive and that they are free to exit the study at any time. After assuring that their responses would
remain confidential, an informed written consent for the same shall be obtained from all participants
Data will be collected using a pre-tested semi-structured proforma to collect sociodemographic details
about the patients participating in the study.
Patients based on convenience sampling will be divided into group A & group B .
Both the groups detailed history will be taken and routine investigation like Hb,TC,DC,ECG, RFT, Urine Routine , Urine Culture, X-Ray KUB, USG KUB and CT-KUB will be taken .
Participants were then randomly assigned into two groups, Group A and Group B. Patients in Group A received Silodosin 8 mg once daily, while those in Group B received Tadalafil 5 mg once daily. The assigned medication was continued until stone expulsion or for a maximum duration of four weeks. Throughout the study, all patients underwent regular assessments, including physical examinations, blood urea and serum creatinine levels, urine culture, and repeat radiological investigations as needed. In addition to the allocated treatment, patients were advised to increase fluid intake and were prescribed Diclofenac 50 mg orally during pain episodes.Patients were followed up for a period of four weeks, during which the primary and secondary endpoints were evaluated. The primary endpoint was the stone expulsion rate, while secondary endpoints included stone expulsion time, defined as the number of days from randomization to the confirmed expulsion of the stone, intervention rates such as the need for ureteroscopy in cases where spontaneous expulsion did not occur, the number of pain episodes experienced by the patient, and adverse effects associated with MET. Stone expulsion was confirmed through CT-KUB and X-ray KUB.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
Inclusion Criteria
- •Patient from 18 years to 60 years Both Genders Patients with ureteric calculi of size 5 to 10 mm in greatest dimension confirmed by CT-KUB and X-Ray KUB .
Exclusion Criteria
- •Patients not willing for study Patients with functional / anatomical abnormalities in ureter Patients with multiple ureteric stone Patients with Bilateral Ureteric stones Pregnant and Lactating mothers Patients with vertigo , cardiac abnormalities, hypotension.
Outcomes
Primary Outcomes
Effectiveness of Silodosin versus Tadalafil as medical expulsive therapy for lower ureteric calculi
Time Frame: Expulsion of ureteric calculi at 0,2and 4 weeks
Secondary Outcomes
- to find out difference in duration of time in Silodosin versus Tadalafil as medical expulsive therapy for lower ureteric calculi(Expulsion of ureteric calculi at 0,2 & 4 weeks)