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TamsulosinNCT06999135

Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones

A study testing Silodosin in people with Tamsulosin and Silodosin, run by Fatima Jinnah Medical University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Tamsulosin, Silodosin, Medical Expulsive Therapy
What is being tested?
Silodosin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 sitePakistan
Study dates
1 Oct 2023to 15 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Previous treatment for the same stone (PCNL/ URS / push back)
  • Solitary Kidney
  • Prior JJ stent insertion
  • Bilateral ureteral stone

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Fatima Jinnah Medical University

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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.

Read the 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.

Being tested
Silodosin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SilodosinDrug

    Also called Sildat, Sildoso

    Silodosin is an oral medication primarily used to treat benign prostatic hyperplasia (BPH) by relaxing the muscles in the prostate and bladder neck to improve urine flow. It belongs to a class of drugs called alpha-1 adrenergic antagonists, which block receptors responsible for muscle contraction in these areas. This action helps relieve symptoms such as difficulty urinating, urgency, and weak urine stream. Silodosin is taken once daily with food and is known for its high selectivity for alpha-1A receptors, contributing to its effectiveness and safety profile

Study groups in NCT06999135
Study groupRoleWhat they receive
TAMSULOSINActive comparatorTamsulosin is an alpha-1 adrenergic receptor blocker commonly used to treat benign prostatic hyperplasia (BPH) by relaxing the smooth muscles in the prostate and bladder neck. In the context of medical expulsive therapy (MET), it helps facilitate the passage of ureteric stones by relaxing the smooth muscles of the lower ureter, reducing ureteric spasm, and easing stone expulsion. It is widely used due to its effectiveness and relatively well-tolerated side effect profile.
Receives: Drug: Silodosin
SilodosinExperimentalSilodosin is used as a medical expulsive therapy (MET) to facilitate the passage of distal ureteral stones, particularly those sized between 4 to 10 mm. It works by selectively blocking alpha-1A adrenergic receptors in the ureter, relaxing the smooth muscle, which helps stones pass more easily and quickly.
Receives: Drug: Silodosin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. STONE EXPULSION RATE

    This measure evaluates the proportion of patients who pass ureteral stones within specific time frames (0-14 days, 15-21 days, and 22-28 days) when treated with Silodosin versus Tamsulosin.

    Measured: 6 MONTHS

  2. TIME TO STONE EXPULSION

    Number of days from treatment initiation to confirmed stone passage, measured by imaging and patient report.

    Measured: 6MONTHS

Secondary outcomes (7)
  1. INCIDENCE OF ORTHOSTATIC HYPOTENSION

    Percentage of patients experiencing orthostatic hypotension, measured by clinical blood pressure monitoring.

    Measured: 6 months

  2. Incidence of Abnormal Ejaculation

    Percentage of patients reporting abnormal ejaculation, assessed via patient questionnaires.

    Measured: 6 months

  3. Incidence of Headache Percentage of patients reporting headaches, assessed via patient questionnaires.

    Percentage of patients reporting headaches, assessed via patient questionnaires.

    Measured: 6 months

  4. Analgesic Requirement:

    Percentage of patients requiring analgesics during treatment, recorded from prescription or patient report.

    Measured: 6 months

  5. Need for Auxiliary Procedures

    Percentage of patients requiring interventions such as ureteroscopy or lithotripsy, documented from clinical records.

    Measured: 6 months

  6. Stone Position and Laterality

    : Distribution of stone location (proximal, mid, distal ureter) and side (right or left), determined by imaging.

    Measured: 6 months

  7. Symptom Duration Prior to CT:

    Categorized duration of symptoms before diagnosis, collected from patient history.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start1 Oct 2023
  3. Primary completion1 Apr 2024
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06999135
Sponsor's protocol ID
No.31-Synopsis-FCPS-Pharma/FJ
Status last verified
May 2025
First submitted
17 Apr 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Itoh Y, Okada A, Yasui T, Hamamoto S, Hirose M, Kojima Y, Tozawa K, Sasaki S, Kohri K. Efficacy of selective alpha1A adrenoceptor antagonist silodosin in the medical expulsive therapy for ureteral stones. Int J Urol. 2011 Sep;18(9):672-4. doi: 10.1111/j.1442-2042.2011.02810.x. Epub 2011 Jun 26.

    PubMed 21707766
  • Thongprayoon C, Krambeck AE, Rule AD. Determining the true burden of kidney stone disease. Nat Rev Nephrol. 2020 Dec;16(12):736-746. doi: 10.1038/s41581-020-0320-7. Epub 2020 Aug 4.

    PubMed 32753740
  • Kino M, Hayashi T, Hino D, Nakada T, Kitoh H, Akakura K. Patients' poor performance status is an independent risk factor for urosepsis induced by kidney and ureteral stones. Urolithiasis. 2021 Oct;49(5):477-484. doi: 10.1007/s00240-021-01256-4. Epub 2021 Mar 23.

    PubMed 33755744
  • 17. REHMAN I, KHAN H, FAROOQ A, MAHMOOD A, DIN QAM, HABIB B. Study on Uroliths Composition in Tertiary Care Hospital of Pakistan. Magnesium. 2021;7:18-9.

  • Halinski A, Bhatti KH, Boeri L, Cloutier J, Davidoff K, Elqady A, Fryad G, Gadelmoula M, Hui H, Petkova K, Popov E, Rawa B, Saltirov I, Spivacow FR, Belthangady Monu Zeeshan Hameed, Trinchieri A, Buchholz N. Stone composition of renal stone formers from different global regions. Arch Ital Urol Androl. 2021 Oct 1;93(3):307-312. doi: 10.4081/aiua.2021.3.307.

    PubMed 34839635
  • Hsu YP, Hsu CW, Bai CH, Cheng SW, Chen KC, Chen C. Silodosin versus tamsulosin for medical expulsive treatment of ureteral stones: A systematic review and meta-analysis. PLoS One. 2018 Aug 28;13(8):e0203035. doi: 10.1371/journal.pone.0203035. eCollection 2018.

    PubMed 30153301
  • Rahman MJ, Faridi MS, Mibang N, Singh RS. Comparing tamsulosin, silodosin versus silodosin plus tadalafil as medical expulsive therapy for lower ureteric stones: A randomised trial. Arab J Urol. 2017 Dec 24;16(2):245-249. doi: 10.1016/j.aju.2017.11.012. eCollection 2018 Jun.

    PubMed 29892490
  • Sharma G, Pareek T, Kaundal P, Tyagi S, Singh S, Yashaswi T, Devan SK, Sharma AP. Comparison of efficacy of three commonly used alpha-blockers as medical expulsive therapy for distal ureter stones: A systematic review and network meta-analysis. Int Braz J Urol. 2022 Sep-Oct;48(5):742-759. doi: 10.1590/S1677-5538.IBJU.2020.0548.

    PubMed 34003612
  • Malin JM Jr, Deane RF, Boyarsky S. Characterisation of adrenergic receptors in human ureter. Br J Urol. 1970 Apr;42(2):171-4. doi: 10.1111/j.1464-410x.1970.tb10018.x. No abstract available.

    PubMed 5420156
  • Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. doi: 10.1016/s0022-5347(01)64173-9.

    PubMed 9334635
  • Ibrahim AI, Shetty SD, Awad RM, Patel KP. Prognostic factors in the conservative treatment of ureteric stones. Br J Urol. 1991 Apr;67(4):358-61. doi: 10.1111/j.1464-410x.1991.tb15161.x.

    PubMed 2032074
  • Pietropaolo A, Proietti S, Geraghty R, Skolarikos A, Papatsoris A, Liatsikos E, Somani BK. Trends of 'urolithiasis: interventions, simulation, and laser technology' over the last 16 years (2000-2015) as published in the literature (PubMed): a systematic review from European section of Uro-technology (ESUT). World J Urol. 2017 Nov;35(11):1651-1658. doi: 10.1007/s00345-017-2055-z. Epub 2017 Jun 7.

    PubMed 28593477
  • Hughes T, Ho HC, Pietropaolo A, Somani BK. Guideline of guidelines for kidney and bladder stones. Turk J Urol. 2020 Nov;46(Supp. 1):S104-S112. doi: 10.5152/tud.2020.20315. Epub 2020 Oct 9.

    PubMed 33052834
  • Strohmaier WL, Wrobel BM, Schubert G. Overweight, insulin resistance and blood pressure (parameters of the metabolic syndrome) in uric acid urolithiasis. Urol Res. 2012 Apr;40(2):171-5. doi: 10.1007/s00240-011-0403-9. Epub 2011 Aug 25.

    PubMed 21866382
  • Ahmed AF, Al-Sayed AY. Tamsulosin versus Alfuzosin in the Treatment of Patients with Distal Ureteral Stones: Prospective, Randomized, Comparative Study. Korean J Urol. 2010 Mar;51(3):193-7. doi: 10.4111/kju.2010.51.3.193. Epub 2010 Mar 19.

    PubMed 20414396

Questions about this trial

What is this clinical trial studying?

A study testing Silodosin in people with Tamsulosin and Silodosin, run by Fatima Jinnah Medical University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

STONE EXPULSION RATE (time frame: 6 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06999135, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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