Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

NCT07617922 | Recruiting Phase 2

• 1 other identifier: FMBSUREC05052026BadawyMS
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Stent-Related Symptoms; Ureteral Calculi; Lower Urinary Tract Symptoms

Keywords

Double-J ureteral stent; Ureteral stent symptoms; Ureteral Stent Symptom Questionnaire; Solifenacin; Melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14

  Postoperative Day 14

• Visual Analogue Scale Pain Score

  Postoperative Day 7 and postoperative Day 14

• Treatment Compliance

  From postoperative Day 0 to postoperative Day 14

Study Arms (3)

Solifenacin

ACTIVE COMPARATOR

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

Melatonin

EXPERIMENTAL

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

Solifenacin Plus Melatonin

EXPERIMENTAL

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; Drug: Melatonin

Interventions

Solifenacin DRUG

Solifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.

Solifenacin; Solifenacin Plus Melatonin

Melatonin DRUG

Melatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.

Melatonin; Solifenacin Plus Melatonin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, BeniSuef, Egypt

RECRUITING

MeSH Terms

Conditions

Ureteral Calculi; Lower Urinary Tract Symptoms

Interventions

Solifenacin Succinate; Melatonin

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indoles; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Hany F Badawy, MD

  Beni suef University hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Mahmoud Abdallah, MD

CONTACT

+201211874080; Drhanyfathy86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to treatment allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1:1 ratio to receive solifenacin, melatonin, or combined solifenacin plus melatonin after unilateral ureteroscopic lithotripsy with Double-J ureteral stent insertion.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)