NCT07617922 Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
| NCT ID | NCT07617922 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beni-Suef University |
| Condition | Ureteral Stent-Related Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 189 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 189 participants in total. It began in 2026-05-07 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 60 years. 2. Patients undergoing unilateral ureteroscopy or ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. 3. Ability to understand and complete the study questionnaires. 4. Willingness to participate and provide written informed consent. Exclusion Criteria: 1. Bilateral ureteral stents. 2. Stents inserted for malignant ureteral obstruction or non-stone reconstructive indications. 3. Known hypersensitivity or contraindication to solifenacin or melatonin. 4. History of acute or chronic urinary retention, or evidence of clinically significant bladder outlet obstruction at baseline. 5. History of narrow-angle glaucoma or other contraindications to antimuscarinic therapy, including gastric retention. 6. Significant hepatic impairment. 7. Severe renal impairment if judged clinically relevant to study medication safety. 8. Pre-existing moderate to severe lower urinary tract symptoms unrelated to the stent. 9. Recent use of antimuscarinics, alpha-blockers, or melatonin that may interfere with symptom assessment. 10. Pregnancy or lactation. 11. Inability to complete follow-up.
Contact & Investigator
Hany F Badawy, MD
PRINCIPAL INVESTIGATOR
Beni suef University hospital
Frequently Asked Questions
Who can join the NCT07617922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Ureteral Stent-Related Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07617922 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07617922 currently recruiting?
Yes, NCT07617922 is actively recruiting participants. Contact the research team at HANYFATHY86@GMAIL.COM for enrollment information.
Where is the NCT07617922 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07617922 clinical trial?
NCT07617922 is sponsored by Beni-Suef University. The principal investigator is Hany F Badawy, MD at Beni suef University hospital. The trial plans to enroll 189 participants.