Ureteral Stent-Related SymptomsPhase 2MEL-SOL-STENTNCT07617922
Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms
A Phase 2 study testing Solifenacin and Melatonin in people with Ureteral Stent-Related Symptoms and Ureteral Calculi, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ureteral Stent-Related Symptoms, Ureteral Calculi, Lower Urinary Tract Symptoms
- What is being tested?
- Solifenacin and Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2026to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, BeniSuef
Hany F Badawy, MD, +201149525028, Hanyfathy86@gmail.com
Mahmoud Abdallah, MD, +201211874080, Drhanyfathy86@GMAIL.COM
About this study
Official title: 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.
Read the 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.
- Being tested
- Solifenacin, Melatonin
- Keywords
- Double-J ureteral stent, Ureteral stent symptoms, Ureteral Stent Symptom Questionnaire, Solifenacin, Melatonin
- Medical subject headings
- Ureteral Calculi, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
Solifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.
MelatoninDrug
Melatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Solifenacin; Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 7
Secondary outcomes (3)
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.
Measured: 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.
Measured: Postoperative Day 7 and postoperative Day 14
Treatment Compliance
Treatment compliance will be assessed according to the number of prescribed doses taken during the 14-day treatment period.
Measured: From postoperative Day 0 to postoperative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start7 May 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent-Related SymptomsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Beni suef University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617922
- Sponsor's protocol ID
- FMBSUREC05052026BadawyMS
- Acronym
- MEL-SOL-STENT
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Versus Solifenacin Versus Their Combination for Improving Double-J Ureteral Stent-Related Symptoms and Quality of Life: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07617922
- Acronym / sponsor ID
- MEL-SOL-STENT / FMBSUREC05052026BadawyMS
- Keywords
- Double-J ureteral stent, Ureteral stent symptoms, Ureteral Stent Symptom Questionnaire, Solifenacin, Melatonin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Solifenacin | Active comparator | Drug: SolifenacinParticipants will receive oral solifenacin 5 mg once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion. |
| Melatonin | Experimental | Drug: MelatoninParticipants will receive oral melatonin 3 mg once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion. |
| Solifenacin Plus Melatonin | Experimental | Drug: Solifenacin, Drug: MelatoninParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolifenacinSolifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion. | Drug | Solifenacin, Solifenacin Plus Melatonin |
| MelatoninMelatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion. | Drug | Melatonin, Solifenacin Plus Melatonin |
Primary outcome
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7
Time frame: 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.
3 secondary outcomes
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14
Time frame: Postoperative Day 14
Visual Analogue Scale Pain Score
Time frame: Postoperative Day 7 and postoperative Day 14
Treatment Compliance
Time frame: From postoperative Day 0 to postoperative Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hany F Badawy, MD principal investigator
Beni suef University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Solifenacin and Melatonin in people with Ureteral Stent-Related Symptoms and Ureteral Calculi, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany F Badawy, MD (+201149525028, HANYFATHY86@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7 (time frame: Postoperative Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.