Kidney StoneNCT07562282
Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
A study testing Tamsulosin in people with Kidney Stone and Ureteric Stone, run by Ain Shams University at 1 site in Egypt.
Trial summary
Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Kidney Stone, Ureteric Stone
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 10 Jul 2026
- Phase
- Interventional
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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.
Who cannot join
- Patients younger than 18 years of age were excluded.
- Patients with a history of prostate or bladder surgery were excluded.
- Patients with prior lower urinary tract procedures were excluded.
- Patients with cancer were excluded.
- Patients with neurological conditions were excluded.
- Patients with a history of pelvic radiation were excluded.
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- Patients with diabetes were excluded.
- Patients with kidney dysfunction (acute or chronic) were excluded.
- Patients with a solitary kidney were excluded.
- Patients with congenital urinary anomalies were excluded.
- Patients taking the following medications were excluded:
- α-blockers
- beta-blockers
- calcium channel blockers
- 5-alpha reductase inhibitors
- PDE5 inhibitors
- anticholinergics
- nitrates
- Patients with cardiac issues were excluded.
- Patients with residual stone fragments after surgery were excluded.
- Patients with multiple or bilateral ureteral stones were excluded.
- Patients with long-term or bilateral stents requiring frequent changes were excluded.
- Patients with interstitial cystitis were excluded.
- Patients with chronic cystitis were excluded.
- Patients with prostatitis were excluded.
- Pregnant women were excluded.
- Breastfeeding women were excluded.
- Patients unavailable for follow-up were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo, Abbasia
Hisham Arafa, Lecturer, +201001921334, Hishamarafa1988@gmail.com
About this study
Official title: Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms
Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life.
Pharmacological management with alpha-blockers such as Tamsulosin and phosphodiesterase-5 inhibitors (PDE5i) such as Tadalafil has shown promise in reducing SRS. While low-dose Tadalafil (2.5 mg) has not been explored, its comparative effectiveness against the standard 5 mg dose when combined with Tamsulosin remains under-researched. This study aims to evaluate the difference in reduction of SRS between Tamsulosin with Tadalafil in standard and half dosage.
Read the detailed description
Ureteral stents are commonly used for temporary drainage in various urological procedures. Despite their usefulness, they are frequently associated with bothersome symptoms collectively termed as "stent-related symptoms" (SRS),These symptoms include flank pain, lower urinary tract symptoms (LUTS), hematuria, dysuria, urgency, frequency, and sexual dysfunction.
The exact pathophysiology of SRS is multifactorial, involving local irritation, vesicoureteral reflux, and smooth muscle spasm.
Various pharmacological agents have been studied to alleviate these symptoms, with alpha-blockers and PDE-5 inhibitors showing promising results .
Tamsulosin, a selective al-blocker, reduces bladder neck and distal ureteral smooth muscle tone, alleviating irritative urinary symptoms.
Tadalafil, a PDE-5 inhibitor, has been shown to improve LUTS through its smooth muscle relaxation and increased perfusion effects. While both have been studied individually and in combination, the optimal dose of Tadalafil in combination therapy is yet to be clearly established
- Conditions
- Kidney Stone, Ureteric Stone
- Being tested
- Tamsulosin
- Medical subject headings
- Kidney Calculi, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Tadalafil
Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg) | Active comparator | About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms Receives: Drug: Tamsulosin |
| Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg) | Active comparator | About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Ureteral Stent Symptoms
Evaluation of Ureteral Stent Symptoms postoperatively using Questionnaire (USSQ) score after treatment (from 1 to 5) as: 1 is best relief of symptoms but 5 is worsen relief of symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Dec 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Amr, Ain Shams University
- Investigators
- Waleed Mousa, Professor, Study director, Assistant Professor of Urology Department of Urology Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562282
- Sponsor's protocol ID
- Ureteric Stent
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided