Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
Recruiting now · Phase 2
Conditions studied: Ureteral Stent-Related Symptoms, Ureteral Calculi, Lower Urinary Tract Symptoms
In brief
Double-J ureteral stents are commonly inserted after ureteroscopy, but they may cause bothersome urinary symptoms, pain, sleep disturbance, and reduced quality of life. This prospective randomized assessor-blinded three-arm clinical trial will compare oral solifenacin, oral melatonin, and their combination for improving ureteral stent-related symptoms in adult patients after unilateral ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. Participants will be randomized to receive solifenacin 5 mg once daily, melatonin 3 mg once nightly, or combined solifenacin 5 mg once daily plus melatonin 3 mg once nightly for 14 days after surgery. The primary outcome is the total Ureteral Stent Symptom Questionnaire score at postoperative Day 7. Secondary outcomes include total Ureteral Stent Symptom Questionnaire score at Day 14, change in questionnaire score between Day 7 and Day 14, Insomnia Severity Index score, Visual Analogue Scale pain score, adverse events, treatment compliance, and rescue analgesic consumption.
Key facts
- Study ID
- NCT07617922
- Run by
- Beni-Suef University
- People needed
- 189
- Starts
- 2026-05-07
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 60 years.
- Patients undergoing unilateral ureteroscopy or ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent.
- Ability to understand and complete the study questionnaires.
- Willingness to participate and provide written informed consent.
You may not qualify if…
- Bilateral ureteral stents.
- Stents inserted for malignant ureteral obstruction or non-stone reconstructive indications.
- Known hypersensitivity or contraindication to solifenacin or melatonin.
- History of acute or chronic urinary retention, or evidence of clinically significant bladder outlet obstruction at baseline.
- History of narrow-angle glaucoma or other contraindications to antimuscarinic therapy, including gastric retention.
- Significant hepatic impairment.
- Severe renal impairment if judged clinically relevant to study medication safety.
- Pre-existing moderate to severe lower urinary tract symptoms unrelated to the stent.
- Recent use of antimuscarinics, alpha-blockers, or melatonin that may interfere with symptom assessment.
- Pregnancy or lactation.
- Inability to complete follow-up.
Where it is running
- Department of Urology- Beni-Suef University Hospitals — Banī Suwayf, BeniSuef, Egypt (enrolling)
Full record on ClinicalTrials.gov
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