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Study of Lidocaine Gel (drug combination) vs Standard Gel for Pain Relief in Patients Undergoing Double-J Ureteral Stent Placement or Exchange

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who need a double-J ureteral stent placed or exchanged, a small tube that helps keep the kidney’s drainage pathway open. Pain relief is provided by a numbing medicine applied to the urethra, known as local anesthesia, which is given during a transurethral procedure (the doctor works through the urethra). Two gels are being compared: the test product Lidocaine gel and the standard gel Instillagel, both designed to numb the area before the stent work.

The purpose of the study is to determine whether the test gel reduces the pain experienced during the stent placement or exchange more effectively than the standard gel.

Participants are randomly assigned to receive either the test gel or the standard gel, and neither the participant nor the doctor knows which one is being used. The gel is applied just before the doctor inserts the cystoscope and performs the stent procedure. Pain intensity is recorded shortly after the procedure and again one hour later, and the overall ease of the procedure and any side effects are also noted. The involvement for each participant is limited to the day of the procedure.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization to study gel

    After joining the study you receive a random assignment to one of two gels. the gel you receive is either a high-dose lidocaine gel (4% lidocaine) or a standard-dose instillagel (2% lidocaine). the assignment is double-blind, meaning you and the staff do not know which gel you have.

  2. Step 2

    Administration of the assigned gel

    The assigned gel is placed into the urethra using a syringe. a total of 11 ml of gel is applied. the gel contains lidocaine for local anesthesia and additional ingredients to help it stay in place. the gel is left in the urethra for the short period recommended by the study staff before the procedure begins.

  3. Step 3

    Transurethral stent placement or exchange

    After the gel has been applied, the physician performs the transurethral procedure to place or exchange a double-j ureteral stent. the time from insertion of the cystoscope to completion of the stent placement is recorded.

  4. Step 4

    Immediate pain assessment

    Within five minutes after the procedure you are asked to rate the strongest pain you felt during the procedure. the rating uses a 100 mm visual analog scale, where 0 mm means no pain and 100 mm means the worst pain possible. the physician also records a global assessment of how easy the procedure was.

  5. Step 5

    One‑hour post‑procedure assessment

    One hour after the stent placement you again rate your pain on the 100 mm visual analog scale. you also answer a question about whether the current symptom state is acceptable to you, called the patient acceptable symptom state (PASS) question.

  6. Step 6

    Monitoring for safety

    Throughout the day the study staff monitors your vital signs (such as blood pressure and heart rate) and asks about any adverse events, which are any new or worsening medical problems that may be related to the gel or the procedure.

  7. Step 7

    Completion of study participation

    After the one‑hour assessments and safety monitoring are finished, your participation in the study is considered complete. you may be discharged according to the usual clinical practice.

Who can join the trial?

5 criteria

  • Provide a signed, written informed consent before any study‑related procedures; this means you agree to take part after understanding what will happen.
  • Be at least 18 years old at the time you sign the consent form.
  • Be scheduled for the placement (insertion) or exchange (removal and replacement) of a double‑J ureteral stent, a small tube used to keep the urine‑carrying tube (ureter) open.
  • Agree to follow all study instructions and any restrictions that are part of the trial.
  • If you are female, you must either be unable to become pregnant (non‑childbearing potential) or, if you could become pregnant (childbearing potential), you must agree to use an approved method of birth control from the start of screening until the study ends.

Who cannot join the trial?

25 criteria

  • Allergy to lidocaine or similar numbing medicines – you cannot join the study if you have a known allergic reaction to lidocaine (a local anesthetic) or any other anesthetic that belongs to the amide class.
  • Problems in the lower urinary tract – any known defect in the bladder or urethra, such as a narrowing of the urethra (urethral strictures), excludes you.
  • Use of medicines or substances that affect pain or alertness – if you are taking any drug or product that could change how you feel pain, cause sedation, dizziness, affect thinking, or interfere with the study’s measurements from the time you stop the drug until one hour after the procedure, you cannot participate.
  • Recent use of cannabis or related products – using marijuana, CBD (cannabidiol), THC (tetrahydrocannabinol), or any synthetic cannabinoid within 7 days before the study start or during the study excludes you.
  • Recent use of illegal or recreational psychoactive drugs – using substances such as psilocybin (magic mushrooms), LSD, MDMA (ecstasy), non‑prescribed ketamine, illegal synthetic cannabinoids, or other hallucinogenic or psychoactive drugs within 30 days before the study start or during the study excludes you.
  • Inability to follow smoking restrictions – while smoking or vaping is not automatically disqualifying, you must be willing and able to stop smoking, vaping, or using nicotine at least one hour before the pain assessment and until one hour after the procedure. If you cannot do this, you are excluded.
  • Alcohol use shortly before the study – drinking any alcoholic beverage within 24 hours before the study start or until one hour after the procedure excludes you.
  • History of certain neurological or psychiatric conditions – if you have diseases such as epilepsy (seizure disorder), severe anxiety, or any condition that could change how you feel pain or affect safety, you cannot join.
  • Significant liver problems – any liver disease that could reduce the body’s ability to clear lidocaine or increase the risk of lidocaine toxicity excludes you.
  • High body weight – a body‑mass index (BMI) of 40 or higher (very high body weight relative to height) excludes you.
  • Positive pregnancy test – if you are a woman of child‑bearing potential and test pregnant, you cannot take part.
  • Use of blood‑thinning medicines that cannot be paused – if you are taking anticoagulants (blood thinners) that cannot be safely stopped, you are excluded because of increased bleeding risk.
  • Breast‑feeding or recent birth – women who are currently breast‑feeding or are less than 6 weeks postpartum cannot participate.
  • Inability to follow the study plan – if you are known or suspected to be unable to follow the clinical study protocol, you cannot join.
  • Incapacity to understand the study – if you cannot understand what the study involves, its purpose, or its possible effects, you are excluded.
  • Any condition that makes the study unsafe or results unreliable – the investigator may exclude you if a medical condition could change the balance of risk and benefit, confuse the study results, or prevent you from completing study requirements.
  • Recent participation in another clinical trial – if you have been in another study within the past 30 days (or longer, based on the drug’s elimination time), you cannot enroll.
  • Being a staff member or close relative of the study team – if you work at the study site, are part of the sponsor or research organization, or are an immediate family member of anyone involved, you are excluded.
  • Allergy to other ingredients in the study medication – a known allergic reaction to substances such as chlorhexidine, methyl‑4‑hydroxybenzoate, propyl‑4‑hydroxybenzoate, hyetellose, propylene glycol, or sodium hydroxide excludes you.
  • History of certain blood or enzyme disorders – conditions like porphyria, glucose‑6‑phosphate dehydrogenase deficiency, or methemoglobinemia make you ineligible.
  • History of urethral or bladder pain syndromes – if you have been diagnosed with urethral syndrome or bladder pain syndrome, you cannot participate.
  • Severe heart rhythm problems – conditions such as very slow heart rate (bradycardia), irregular heartbeat (atrial fibrillation), heart block, or heart failure exclude you.
  • Pelvic tumors that interfere with the procedure – any tumor in the pelvic area that would prevent or complicate the stent placement makes you ineligible.
  • Frequent urinary tract infections – ongoing or recurrent bladder infections that could affect safety or study assessments exclude you.
  • Damage to the lining of the urinary tract – injuries such as abrasions, ulcers, or cuts in the mucosal surfaces around the urethra exclude you.
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Investigated drugs

  • Instillagel

    is a sterile gel applied into the urethra that contains a local anesthetic (lidocaine) to numb the area and an antiseptic (chlorhexidine) to help keep the site clean. It also includes small amounts of preservatives to keep the product stable. In this study, Instillagel is used as the standard treatment (comparator) so researchers can see how well the new gel works compared to the usual care during placement or exchange of a ureteral stent.

  • Lidocaine gel

    is the investigational product being tested. Like the comparator, it is a urethral gel that provides lidocaine for pain relief and chlorhexidine for antiseptic protection, plus the same preservatives. The key difference is that this gel uses a higher concentration of lidocaine, intended to give stronger and longer‑lasting numbness. The trial evaluates whether this higher‑strength gel can reduce the pain patients feel during the stent procedure more effectively than the standard gel.

What is already known about the treatment

  • Instillagel 11 ml, Gel

    This gel is applied directly into the urethra as a thin coating before the procedure, delivering lidocaine for pain relief and chlorhexidine to keep the area clean. It is an approved, widely used product that appears in many medical guidelines and studies. It is meant to lessen discomfort and reduce infection risk during ureteral stent placement or exchange. The lidocaine numbs by blocking nerve signals, while chlorhexidine kills germs, and the product is classified as a topical anesthetic‑antiseptic gel.

  • Lidocaine gel

    The test gel is also placed into the urethra, but it contains a higher amount of lidocaine (4 %) to provide stronger pain control during the same procedures. It is currently being studied in clinical trials, although its ingredients are already approved and well known. It is used to reduce pain and prevent infection when inserting or changing a double‑J ureteral stent. The lidocaine works by stopping pain signals, chlorhexidine cleans the area, and the whole preparation is classified as a topical anesthetic gel.

Investigated diseases

Placement or exchange of double-J (DJ) ureteral stent - This condition involves a blockage or narrowing in the ureter that interferes with the normal flow of urine from the kidney to the bladder. Over time, the obstruction can develop slowly due to kidney stones, scar tissue, or other causes, leading to urine buildup in the kidney. The blockage may worsen, causing discomfort and changes in urination. To keep the ureter open, a thin tube called a double‑J stent is inserted or replaced periodically. The need for repeated stent placement reflects the ongoing nature of the underlying ureteral problem.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526288-40-00Protocol codeHiLIDOEstimated enrolment182 patients

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