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OpenTrials
Completed

NCT Number: NCT06955533

Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms

This study was a randomized clinical trial conducted on 64 Egyptian patients from the outpatient clinic at Ain Shams University Hospital over a six-month period from 3/2024 to 9/2024.The study population was randomized into 2 groups. Group A included 32 patients with stent related symptoms receiving double doses of tamsulosin (Tamsulin® 0.4 mg 2 capsules taken together per day) and Solifenacin 10mg (Sofenacin® 10mg tab taken once daily).Group B included 32 patients with stent related symptoms receiving a standard dose of tamsulosin (0.4 mg once daily) and solifenacin (5 mg once daily).

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Key information

Conditions

Stent Related Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • We included patients older than18 years of age, with presence of a double-J (DJ) stent in place, suffering from lower urinary tract symptoms (LUTS).Patients younger than 18 years of age, patients with a history of prostate or bladder surgery, lower urinary tract procedures, cancer, neurological conditions, pelvic radiation, diabetes, kidney dysfunction (acute or chronic), a solitary kidney, congenital urinary anomalies, or those taking medications such as α-blockers, beta-blockers, calcium channel blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, anticholinergics, or nitrates were excluded. Additionally, patients with cardiac issues, residual stone fragments after surgery, multiple or bilateral ureteral stones, long-term or bilateral stents requiring frequent changes, interstitial cystitis, chronic cystitis, prostatitis, pregnant or breastfeeding women, and those unavailable for follow-up were also excluded from the study.

Exclusion criteria

-

Treatment and study plan

Double dose tamsulosin and solifenacin

Drug

Odd number

Single dose tamsulosin and solifenacin

Drug

Even number

Primary outcomes

  1. Improvement of ussq

    Time frame: 2 weeks

    This is a pilot study aiming to evaluate the effectiveness of Double dose versus standard dose of tamsulosin with solifenacin in relieving stent related symptoms.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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