Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeni-Suef University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Solifenacin
DrugSolifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.
Melatonin
DrugMelatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.
Treatment groups
189 Participants
are divided into 3 treatment groupsGroup A: SolifenacinActive comparator 1 intervention
Group B: MelatoninExperimental treatment 1 intervention
Group C: Solifenacin Plus MelatoninExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Postoperative Day 7Secondary outcomes
1
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.
Time frame
Postoperative Day 142
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.
Time frame
Postoperative Day 7 and postoperative Day 143
Treatment Compliance
Treatment compliance will be assessed according to the number of prescribed doses taken during the 14-day treatment period.
Time frame
From postoperative Day 0 to postoperative Day 14Sponsors and contacts
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Source ClinicalTrials.gov