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Sleep aid and bladder drug tested to ease stent discomfort

NCT ID NCT07617922

Symptom relief Sponsor: Beni-Suef University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares melatonin, solifenacin, and their combination to reduce bothersome urinary symptoms and pain caused by a temporary ureteral stent placed after kidney stone surgery. About 189 adults will take one of the two drugs or both for 14 days. The goal is to see which approach improves quality of life and sleep the most.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 189 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Lower Urinary Tract Symptoms Ureteral Calculi ureterolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower urinary tract symptoms Ureteral calculi Ureteral stent-related symptoms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Urology- Beni-Suef University Hospitals

    RECRUITING

    Banī Suwayf, BeniSuef, Egypt

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