Actively Recruiting
Melatonin Versus Solifenacin Versus Their Combination for Improving Double-J Ureteral Stent-Related Symptoms and Quality of Life: A Prospective Randomized Study
Led by Beni-Suef University · Updated on 2026-06-02
189
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have undergone unilateral ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. The trial aims to compare the effects of oral solifenacin, oral melatonin, and their combination on relieving symptoms related to the ureteral stents, which often cause discomfort, urinary symptoms, pain, sleep problems, and reduced quality of life. This is a phase 2, randomized, assessor-blinded study conducted at a single center. Participants are randomly assigned to one of three groups: one receives solifenacin 5 mg once daily, another takes melatonin 3 mg once nightly, and the third group receives both solifenacin 5 mg once daily and melatonin 3 mg once nightly. The treatments start immediately after surgery and hospital discharge and continue for 14 days. The study includes evaluations at postoperative Day 7 and Day 14. During the study, participants will complete questionnaires to assess ureteral stent symptoms, sleep quality, and pain levels. Researchers will record the total symptom scores, pain scores, treatment compliance, use of rescue pain medication, and any side effects. The main measurement is the symptom questionnaire score at Day 7. Participants will be monitored through these assessments over the two-week treatment period to better understand how the medications affect stent-related symptoms and quality of life.
CONDITIONS
Brief Title
Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years
- Undergoing unilateral ureteroscopy or ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent
- Ability to understand and complete study questionnaires
- Willingness to participate and provide written informed consent
You will not qualify if you...
- Bilateral ureteral stents
- Stents inserted for malignant ureteral obstruction or non-stone reconstructive reasons
- Known allergy or contraindication to solifenacin or melatonin
- History of acute or chronic urinary retention or significant bladder outlet obstruction
- History of narrow-angle glaucoma or contraindications to antimuscarinic therapy including gastric retention
- Significant liver impairment
- Severe kidney impairment if it affects medication safety
- Moderate to severe lower urinary tract symptoms not related to the stent
- Recent use of antimuscarinics, alpha-blockers, or melatonin that may interfere with symptom assessment
- Pregnancy or breastfeeding
- Inability to complete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive solifenacin, melatonin, or their combination for 14 days following unilateral ureteroscopic lithotripsy with Double-J ureteral stent insertion.
1 baseline visit and 2 follow-up visits at postoperative Day 7 and Day 14
Trial Site Locations
Total: 1 location
1
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, BeniSuef, Egypt
Actively Recruiting
Research Team
H
Hany F Badawy, MD
M
Mahmoud Abdallah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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