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New treatment option for Ureteral Stent-Related Symptoms
Official title Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
ClinicalTrials.gov ID: NCT07617922
What this study is testing
What is Solifenacin?
Solifenacin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ureteral stent-related symptoms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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 likely can't join 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Banī Suwayf, BeniSuef, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banī Suwayf, BeniSuef, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.