Melatonin and Solifenacin for stent-related symptoms after ureteroscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, assessor-blinded trial, adults undergoing unilateral ureteroscopic lithotripsy with a unilateral Double-J stent are assigned to solifenacin, melatonin, or the combination for 14 days after surgery. The primary outcome is the Ureteral Stent Symptom Questionnaire score at postoperative day 7, with secondary outcomes including day 14 scores, sleep quality, pain, adverse events, and rescue analgesic use. The study uses Arabic-validated instruments and is conducted at Beni-Suef University Hospital in Egypt with blinded outcome assessment. Participants are aged 18 to 60 and must meet inclusion criteria and provide informed consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, BeniSuef, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Beni suef University hospital
• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.