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RecruitingNCT07562282Updated May 1, 2026

Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg

An interventional study of Tamsulosin in Kidney Stone and Ureteric Stone, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 71 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Dec 2025, registered Apr 2026).
  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 71 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Kidney Stone
  • Ureteric Stone
03

In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's planned enrollment of 140 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Ain Shams University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 71 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)

    About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms

    Drug: Tamsulosin

  • Active comparator
    Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)

    About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms

    Drug: Tamsulosin

Interventions

  • DrugTamsulosin

    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.

    Also known as: Tadalafil

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Jul 2026, 7 months after the start.

Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 7 months is below that.

Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2026
First posted
May 1, 2026
StartActual
Dec 1, 2025
Primary completionEst.
Jul 1, 2026
CompletionEst.
Jul 10, 2026
Last update
May 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07562282
Lead sponsor
Ain Shams University
Responsible party
Ahmed Amr (Resident at Urology Department, Ain Shams University) — Principal investigator
First posted
May 1, 2026
Start date
Dec 1, 2025
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 10, 2026 (estimated)
Last update
May 1, 2026

Study contacts

Ahmed Amr Mohammed Mounier, MSc
Contact
160022@med.asu.edu.eg
+201111984645
Waleed Mousa, Professor
Contact
Waleedmousa@med.asu.edu.eg
+201067628771
Waleed Mousa, Professor
study director · Assistant Professor of Urology Department of Urology Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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