Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms (MEL-SOL-STENT)

Melatonin Versus Solifenacin Versus Their Combination for Improving Double-J Ureteral Stent-Related Symptoms and Quality of Life: A Prospective Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms; Ureteral Calculi; Ureteral Stent-Related Symptoms
• Intervention / Treatment: Drug: Solifenacin; Drug: Melatonin

Detailed Description

This is a single-center, prospective, randomized, assessor-blinded, parallel-group, three-arm clinical trial conducted at the Department of Urology, Beni-Suef University Hospital, Egypt.

The study will include adult patients aged 18 to 60 years undergoing unilateral ureteroscopic lithotripsy for ureteral stones with postoperative insertion of a unilateral Double-J ureteral stent. Eligible patients who provide written informed consent will be randomized into one of three treatment groups.

Participants in Group A will receive solifenacin 5 mg once daily. Participants in Group B will receive melatonin 3 mg once nightly. Participants in Group C will receive combined solifenacin 5 mg once daily plus melatonin 3 mg once nightly. Study medication will start immediately after surgery and hospital discharge and will continue for 14 days.

Outcome assessors will remain blinded to treatment allocation throughout the study period. Study assessments will be performed at postoperative Day 7 and postoperative Day 14. Ureteral stent-related symptoms and quality of life will be assessed using the Arabic-validated Ureteral Stent Symptom Questionnaire. Sleep-related symptoms will be assessed using the Arabic version of the Insomnia Severity Index. Pain will be assessed using a Visual Analogue Scale. Drug-related adverse events, treatment compliance, and rescue analgesic consumption will also be recorded during follow-up.

The primary endpoint is the difference among the three study groups in total Ureteral Stent Symptom Questionnaire score at postoperative Day 7.

• Study Type: Interventional
• Enrollment (Estimated): 189
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hany F Badawy, MD; Phone Number: +201149525028; Email: HANYFATHY86@GMAIL.COM
• Study Contact Backup: Name: Mahmoud Abdallah, MD; Phone Number: +201211874080; Email: Drhanyfathy86@GMAIL.COM

Study Locations

• Egypt
  • BeniSuef
    • Banī Suwayf, BeniSuef, Egypt
      • Recruiting
      • Department of Urology- Beni-Suef University Hospitals
      • Contact: Hany F Badawy, MD; Phone Number: +201149525028; Email: HANYFATHY86@GMAIL.COM
      • Contact: Mahmoud Abdallah, MD; Phone Number: +201211874080; Email: Drhanyfathy86@GMAIL.COM
      • Principal Investigator: Hany F Badawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Solifenacin; Participants will receive oral solifenacin 5 mg once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.	Drug: Solifenacin; Solifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.
Experimental: Melatonin; Participants will receive oral melatonin 3 mg once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.	Drug: Melatonin; Melatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.
Experimental: Solifenacin Plus Melatonin; Participants will receive oral solifenacin 5 mg once daily plus oral melatonin 3 mg once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.	Drug: Solifenacin; Solifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.; Drug: Melatonin; Melatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7	The Arabic linguistically validated version of the Ureteral Stent Symptom Questionnaire (USSQ) will be used at postoperative Day 7. The USSQ is a multidimensional questionnaire assessing six domains: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. Domain scores range from 6 to 42 for urinary symptoms, 5 to 35 for body pain, 5 to 25 for general health, 4 to 20 for work performance, 4 to 20 for sexual matters, and 3 to 15 for additional problems. The total score will be calculated as the sum of the six domain scores, with a possible total score range from 27 to 157. Higher scores indicate worse ureteral stent-related symptoms and poorer health-related quality of life.	Postoperative Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Compliance	Treatment compliance will be assessed according to the number of prescribed doses taken during the 14-day treatment period.	From postoperative Day 0 to postoperative Day 14
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14	The Arabic linguistically validated version of the Ureteral Stent Symptom Questionnaire (USSQ) will be used at postoperative Day 14. The USSQ is a multidimensional questionnaire assessing six domains: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. Domain scores range from 6 to 42 for urinary symptoms, 5 to 35 for body pain, 5 to 25 for general health, 4 to 20 for work performance, 4 to 20 for sexual matters, and 3 to 15 for additional problems. The total score will be calculated as the sum of the six domain scores, with a possible total score range from 27 to 157. Higher scores indicate worse ureteral stent-related symptoms and poorer health-related quality of life.	Postoperative Day 14
Visual Analogue Scale Pain Score	Pain severity will be assessed using a Visual Analogue Scale. The possible score range is 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.	Postoperative Day 7 and postoperative Day 14

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Hany F Badawy, MD, Beni suef University hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Melatonin; Solifenacin; Double-J ureteral stent; Ureteral stent symptoms; Ureteral Stent Symptom Questionnaire
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Urological Manifestations; Ureteral Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ureterolithiasis; Ureteral Calculi; Lower Urinary Tract Symptoms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Heterocyclic Compounds, Bridged-Ring; Tryptamines; Tetrahydroisoquinolines; Isoquinolines; Quinuclidines; Solifenacin Succinate; Melatonin
• Other Study ID Numbers: FMBSUREC05052026BadawyMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Only aggregated, de-identified study results will be reported. Individual-level data will remain confidential and will be accessible only to the study investigators and authorized regulatory or ethics committee representatives if required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No