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Trial details
Efficacy of levocetirizine IN reducing Double J stent-related symptoms: A double-blind pilot randomized controlled trial
Current status:
Approved
|
Date registered:
29/10/2025
|
Date last updated:
28/10/2025
Trial version(s)
Current: 20/07/2025
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Main Information
Primary registry identifying number
LBCTR2025105754
Protocol number
CR: 3/2024
MOH registration number
*
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
01/10/2024
Primary sponsor
N/A
Primary sponsor: Country of origin
Lebanon
Public title
Efficacy of levocetirizine IN reducing Double J stent-related symptoms: A double-blind pilot randomized controlled trial
Acronym
Scientific title
Efficacy of levocetirizine IN reducing Double J stent-related symptoms: A double-blind pilot randomized controlled trial
Acronym
Brief summary of the study: English
Efficacy of Levocetirizine in Reducing Double J Stent–Related Symptoms: A Double‑Blind Pilot Randomized Controlled Trial Background and Rationale: Double‑J (DJ) ureteral stents are commonly used to ensure urinary drainage but often cause bothersome symptoms such as dysuria, urgency, frequency, and flank pain, which impair patients’ quality of life. The exact pathophysiology of these symptoms remains unclear, but histamine release and local immune‑mediated mechanisms may play a role. Cetirizine, a second‑generation H1‑antihistamine with predominant renal excretion, could reduce stent‑related inflammation and irritation. Objectives: To evaluate the efficacy and safety of levocetirizine (XYZAL 5 mg) compared to placebo in reducing DJ stent–related symptoms and improving quality of life in adult patients undergoing ureteral stenting for obstructive ureteral disease. Study Design: This is a double‑blind, placebo‑controlled, pilot randomized clinical trial conducted at five urological clinics at CHU Notre Dame des Secours (Jbeil‑Byblos, Lebanon) between March 2024 and March 2025. Eligible adult patients (>18 years) undergoing DJ stent placement will be randomized using sealed opaque envelopes into two groups: Group A: placebo once daily plus standard care. Group B: levocetirizine 5 mg once daily plus standard care. Treatment starts ≥2 hours pre‑operatively and continues until stent removal (maximum 3 weeks). Assessments: At stent removal (≤3 weeks), patients will undergo ureteroscopy for macroscopic evaluation (inflammation, calcification) and complete validated questionnaires (USSQ and Visual Analogue Scale for pain). Safety and tolerability will also be assessed.
Brief summary of the study: Arabic
فعالية الليفوسيتريزين في تخفيف الأعراض الناتجة عن دعامة الحالب (Double‑J): تجربة عشوائية مضبوطة مزدوجة التعمية الخلفية والدافع: تُستخدم دعامات الحالب من نوع Double‑J بشكل واسع لضمان تصريف البول، إلا أنها غالبًا ما تسبب أعراضًا مزعجة مثل حرقة البول، وتكرار التبول، والإلحاح البولي، وألم الخاصرة، مما يؤثر سلبًا على نوعية حياة المرضى. لا تزال الآلية المسببة لهذه الأعراض غير واضحة تمامًا، لكن يُعتقد أن إفراز الهيستامين والآليات المناعية الموضعية تلعب دورًا في ذلك. قد يساهم دواء السيتريزين، وهو من مضادات الهيستامين من الجيل الثاني ويُطرح بشكل رئيسي عبر الكلى، في تخفيف التهيج والالتهاب الناتج عن الدعامة. الأهداف: تقييم فعالية وسلامة دواء ليفوسيتريزين (XYZAL 5 ملغ) مقارنةً بالدواء الوهمي في تخفيف الأعراض المرتبطة بدعامات الحالب وتحسين نوعية الحياة لدى المرضى البالغين الذين خضعوا لتركيب دعامة بسبب انسداد في الحالب. تصميم الدراسة: دراسة سريرية أولية عشوائية مزدوجة التعمية ومضبوطة بالدواء الوهمي، تُجرى في خمسة عيادات مسالك بولية في مستشفى جامعة سيدة المعونات الجامعي (جبيل – لبنان) بين آذار 2024 وآذار 2025. يتم توزيع المرضى البالغين المؤهلين (>18 سنة) عشوائيًا بواسطة أظرف مغلقة إلى مجموعتين: المجموعة أ: حبة دواء وهمي يوميًا مع العناية القياسية. المجموعة ب: حبة ليفوسيتريزين 5 ملغ يوميًا مع العناية القياسية. يبدأ العلاج قبل العملية بساعتين على الأقل ويستمر حتى إزالة الدعامة (بحد أقصى 3 أسابيع). التقييمات: عند إزالة الدعامة (≤3 أسابيع)، يخضع المرضى لتنظير الحالب لتقييم المظهر العياني (التهاب، تكلسات) ويكملون استبيانات معتمدة (استبيان أعراض الدعامة USSQ ومقياس بصري للألم VAS). كما يتم تقييم السلامة والتحمل.
Health conditions/problem studied: Specify
Obstructive ureteral disease requiring temporary urinary drainage with a double‑J ureteral stent Associated double‑J stent–related lower urinary tract symptoms (dysuria, frequency, urgency, flank pain) and stent‑related discomfort
Interventions: Specify
Group B (Experimental Group): Levocetirizine (XYZAL) 5 mg oral tablet once daily Administration starts at least 2 hours pre‑operatively and continues daily until stent removal (maximum 3 weeks) Given in addition to standard post‑operative analgesic and anti‑inflammatory treatment Group A (Control Group): Placebo oral tablet once daily Administration starts at least 2 hours pre‑operatively and continues daily until stent removal (maximum 3 weeks) Given in addition to standard post‑operative analgesic and anti‑inflammatory treatment
Key inclusion and exclusion criteria: Inclusion criteria
Adults aged 18 years or older. Patients who underwent double J ureteral stent placement for obstructive ureteral disease at CHU-NDS. Patients who are able and willing to provide written informed consent. Patients capable of complying with study procedures and follow‑up requirements.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
80
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion criteria: Radiation-induced ureteritis Pregnancy or breastfeading Malignancy or extrinsic ureter obstruction Known allergy or CI to the study drugs Previous ureteral stenting Patient taking anti-allergic in the previous month Refusal to provide consent
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Placebo
Study phase
2 to 3
Study design: Purpose
Prevention
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
USA. EU. ME.AUS
Name of IMP
Levocetirizine dihydrochloride (brand name: XYZAL)
Year of authorization
2001
Type of IMP
Others
Type of IMP: Specify
Authorized medicinal product (second‑generation H1‑receptor antagonist antihistamine)
Pharmaceutical class
Levocetirizine (XYZAL): Second‑generation H1‑receptor antagonist (antihistamine).
Therapeutic indication
Levocetirizine (XYZAL) is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and chronic idiopathic urticaria.
Therapeutic benefit
As a second‑generation H1‑antihistamine, levocetirizine: Reduces histamine‑mediated symptoms such as sneezing, rhinorrhea, nasal congestion, and itching. Provides long‑lasting relief (24‑hour efficacy with once‑daily dosing). Has minimal sedative effects compared to first‑generation antihistamines. Improves patient quality of life by decreasing allergic symptoms and related discomfort.
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
60
Actual enrollment target size
85
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/03/2025
Date of study closure: Type
Anticipated
Date of study closure: Date
31/03/2026
Recruitment status
Complete
Date of completion
27/10/2025
IPD sharing statement plan
No
IPD sharing statement description
Individual participant data (IPD) from this study will not be shared. This decision is due to privacy and confidentiality concerns, as sharing de‑identified raw data may still carry a risk of re‑identification of participants. Therefore, to fully comply with data protection regulations and ensure participant privacy, IPD will not be made available.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Not sponsored
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
rodrigue
saad
byblos
Lebanon
71240014
rodriguesaad@usek.edu.lb
supervisor
Scientific
marc
elias
byblos
Lebanon
70445079
marc_elias@live.com
study conductor
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
CHU-NDS
Marc Elias. Rodrigue Saad
Urology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Notre Dame des Secours Centre Hospitalier Universitaire
01/10/2024
Marc Elias
marc_elias@live.com
70445079
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
ureteral obstruction
Urinary calculus, unspecified (N20.9)
lithiasis, double J stent
Interventions
Intervention
Description
Keyword
Double J placement + giving ,edication
placement of double J + giving either xyal 5mg daily or olacebo than double j removal and evaluationg irritating symptoms
double J stent, lithiasis, antihistamin
Primary Outcomes
Name
Time points
Measure
Ureteral inflammation
uponureteroscopy
macroscopically (inflammed or no)
double J stent
upon ureteroscopy
calcified or no
USSQ
after ureteroscopy
ureteral stent symptoms questionnaire
Key Secondary Outcomes
Name
Time points
Measure
VAS
upon ureteroscopy
visual analogue pain scale
Trial Results
Summary results in Lebanon
This Lebanese pilot randomized controlled trial at Notre Dame des Secours University Hospital and Bcharre Hospital demonstrated that a 5 mg daily dose of levocetirizine, initiated pre-emptively at least 2 hours before surgery and continued for the entire stenting period, significantly reduced double-J stent-related morbidity and pain compared to placebo. Efficacy was confirmed through validated patient-reported outcomes (USSQ and VAS) and objective intraoperative findings of reduced ureteral inflammation. The study highlights that prophylactic, continuous antihistamine therapy targeting a potential allergic-inflammatory pathway is a well-tolerated and effective strategy for managing the pervasive problem of stent-related discomfort in the Lebanese population.
Study results globally
This is the first study to investigate the efficacy of pre-emptive and continuous administration of levocetirizine, a renally-excreted antihistamine, for the specific purpose of reducing double-J stent symptoms. It builds on a previous proof-of-concept trial by introducing key methodological refinements in drug selection, timing, and objective assessment.
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
This multi-center pilot RCT enrolled 82 adult patients (aged 18-80 years) from five urological clinics in Lebanon who underwent double-J stent placement for obstructive ureteral disease. After excluding 3 patients, 79 participants were included and randomized into two groups using a sealed opaque envelope technique: Group A (Control): n=40, received once-daily placebo + standard analgesic therapy. Group B (Intervention): n=39, received once-daily levocetirizine 5 mg + standard analgesic therapy. Key Inclusion/Exclusion: Exclusion Criteria: Included known allergy to the study drug, radiation-induced ureteritis, malignancy, previous stenting, pregnancy, end-stage renal disease, solitary kidney, and recent use of anti-allergic medications. Data Collected: At baseline, demographic and clinical data were documented, including age, BMI, medical history, stone characteristics (size, location), and stent specifications. Notable Methodological Points: The trial was open-label (not blinded) due to the impracticality of producing a matched placebo. The study drug was initiated pre-emptively (≥2 hours pre-op) and continued for the full stenting period (up to 3 weeks). Outcome assessment combined subjective patient-reported measures (USSQ, VAS) with objective macroscopic evaluation of the ureter and stent during removal. Patients were monitored regularly for side effects. No unusual or previously undocumented side effects from the study medications were reported. Patients were instructed to contact their referring physician if any side effects occurred.
Participant flow
The trial initially screened 82 patients. After pre-randomization exclusions (n=3; reasons consistent with the exclusion criteria such as drug allergies or refusal to consent), 79 participants were randomized into two groups: Group A (Placebo, n=40) and Group B (Levocetirizine, n=39). The document notes that a further number of patients were excluded after randomization due to loss to follow-up, but the final count for the per-protocol analysis is pending this data.
Adverse events
The study concluded that levocetirizine demonstrated a favorable safety profile comparable to placebo. No specific adverse events are detailed in the provided text, but it underscores the drug's well-tolerated nature as an adjunctive therapy. Patients were monitored regularly for side effects. No unusual or previously undocumented side effects from the study medications were reported. Patients were instructed to contact their referring physician if any side effects occurred.
Outcome measures
The primary outcome was assessed on the day of stent removal (within 3 weeks) via three key tools: Ureteral Stent Symptom Questionnaire (USSQ): A validated multi-domain questionnaire to quantify stent-related symptoms and impact on quality of life. The levocetirizine group showed a significant reduction in scores. Visual Analogue Scale (VAS) for Pain: A 10-cm scale where patients self-reported pain. The levocetirizine group reported significantly lower pain scores. Intraoperative Macroscopic Evaluation: Surgeons directly assessed and documented signs of ureteral inflammation (edema, erythema) and stent encrustation. The levocetirizine group showed objectively less inflammation.
URL to protocol files
N/A
Link(s) to publications related to the study
Changes History
Change
Date
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