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

NCT06955533 | Completed DMC

• 1 other identifier: FMASU MS23/ 2023
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stent Related Symptoms

Outcome Measures

Primary Outcomes (1)

• Improvement of ussq

  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.

  2 weeks

Study Arms (2)

Double dose tamsulosin ans solifenacin

ACTIVE COMPARATOR

Drug: Double dose tamsulosin and solifenacin

Single dose tamsulosin and solifenacin

ACTIVE COMPARATOR

Drug: Single dose tamsulosin and solifenacin

Interventions

Double dose tamsulosin and solifenacin DRUG

Odd number

Double dose tamsulosin ans solifenacin

Single dose tamsulosin and solifenacin DRUG

Even number

Single dose tamsulosin and solifenacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

MeSH Terms

Interventions

Solifenacin Succinate; Tamsulosin

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: H arafa

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 2, 2025

Record last verified: 2024-04

Locations

EG (1)