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Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

NCT07617922 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2026-06-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Hany F Badawy, MD · Beni suef University hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-07
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617922 on ClinicalTrials.gov