NephrolithiasisPhase 2NCT04726345
Effect of Antihistamines on Ureteral Stent-Related Symptoms
A Phase 2 study testing Fexofenadine Hcl 180Mg Tab in people with Nephrolithiasis, run by Columbia University at 1 site in United States.
Trial summary
This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Fexofenadine Hcl 180Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones
Who cannot join
- Preoperative use of antihistamines, beta-3 agonists, anticholinergics, corticosteroids, and chronic opioid analgesic use
- Preoperative indwelling ureteral stent at the time of treatment
- Neurogenic bladder, ureteral stricture, interstitial cystitis, or chronic prostatitis
- Pregnancy or breastfeeding
- Planned bilateral ureteroscopy
- Solitary or transplanted kidney
Show all 9Show fewer
- Hypersensitivity to antihistamines
- Severe renal disease (glomerular filtration rate (GFR) < 10 ml/min or on dialysis)
- Significant deviation in operative plan (ureteral stent not deemed necessary, incidental urologic malignancy, tandem ureteral stent placement, second-stage procedure required)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/NYP
New York, New York, 10032
About this study
Official title: Effect of Antihistamines on Ureteral Stent-Related Symptoms: Randomized Controlled Trial
This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones. Eligible patients will be randomly and divided into two groups in a 1:1 ratio. Group A will receive fexofenadine 180 mg once daily in addition to standard of care treatment. Group B will receive placebo in addition to standard of care treatment. The routine standard of care treatment will consist of oral non-steroidal anti-inflammatory drugs (NSAIDs).
The primary outcomes of the study are the Ureteral Stent Symptom Questionnaire (USSQ) urinary symptom score and pain score. Secondary outcomes include (i) number of office phone calls due to urinary symptoms; (ii) duration of analgesic use; (iii) duration and quantity of narcotic use; (iv) number of emergency department visits; (v) drug-related adverse effects; (vi) other domains of the USSQ.
Read the detailed description
Ureteral stents treat ureteral obstruction, allow for passive dilation of the ureter, maintain urine flow to the bladder, and aid in the recovery of the ureter after endoscopic surgery or ureteral injury. These stents are routinely utilized after urologic procedures for the treatment of urolithiasis and are generally kept in place for 1-2 weeks following the procedure. Despite their advantages, indwelling ureteral stents cause discomfort and reduce patient quality of life. These symptoms are partially attributed to local irritation to the ureter and bladder. Bothersome stent-related symptoms include urinary urgency, frequency, flank pain, hematuria, dysuria, sexual side effects, and emotional distress. The majority of patients with ureteral stents experience symptoms post-operatively.
Several studies have indicated that agents such as antimuscarinics or alpha-1 adrenergic receptor antagonists may improve stent-related symptoms. The indications for anticholinergic medications are based on blocking involuntary bladder muscle contraction; however, the efficacy of these drugs is still controversial. Furthermore, these medications have potential adverse side effects.
Antihistamines also show potential in alleviating stent-related symptoms. Multiple in vitro studies have shown H1 receptor activity involved both in ureteral peristalsis and in bladder contraction. Both first- and second-generation H1 antagonists have shown activity in the urinary tract. In clinical practice, antihistamines are commonly utilized in the management of bladder pain caused by interstitial cystitis. Additionally, a randomized controlled trial found efficacy of antihistamines for pain management in the setting of renal colic from obstructing ureteral stones. There is novel evidence that in patients with indwelling stents, there are inflammatory changes in the bladder with an associated eosinophilic reaction. Eosinophilic cystitis is commonly associated with bladder irritation or allergy, and these findings point to a novel paradigm of treating patients with antihistamines. To our knowledge, no studies have evaluated the efficacy of antihistamines for managing stent-related symptoms.
- Conditions
- Nephrolithiasis
- Being tested
- Fexofenadine Hcl 180Mg Tab, Placebo
- Keywords
- Antihistamines, Ureteral stent
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexofenadine Hcl 180Mg TabDrug
Also called Fexofenadine
Fexofenadine 180mg tablet to be taken orally once a day until stent removal.
PlaceboDrug
Also called Placebo Tablet
Placebo tablet to be taken orally once a day until stent removal.
| Study group | Role | What they receive |
|---|---|---|
| Fexofenadine | Experimental | Participants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs). Receives: Drug: Fexofenadine Hcl 180Mg Tab |
| Placebo | Placebo comparator | Participants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
USSQ Urinary Symptom Score
Ureteric Stent Symptoms Questionnaire (USSQ) is a self-administered questionnaire to evaluate the overall impact of ureteral stents on different aspects of life. Urinary symptom will be assessed at different time points. The urinary symptom section consists of 11 questions. The total score range is 11 to 54 points. Higher scores represent increasing symptom severity.
Measured: Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)
USSQ Body Pain Score
Ureteric Stent Symptoms Questionnaire (USSQ) is a self-administered questionnaire to evaluate the overall impact of ureteral stents on different aspects of life. Body pain will be assessed at different time points. The body pain section consists of 7 questions. The total score range is 0 to 37 points. Higher scores represent increasing pain.
Measured: Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)
Secondary outcomes (5)
Number of Office Phone Calls Due to Urinary Symptoms and Pain
This is to measure the morbidity associated with the indwelling ureteral stent. Urinary symptoms will include urinary frequency, urgency, incontinence, nocturia, incomplete emptying, dysuria, and hematuria. Total number of calls per group are reported.
Measured: After stent removal (1-2 weeks after surgery)
Duration of NSAID Use
This is to measure morbidity associated with the indwelling ureteral stent. Duration will be reported in days.
Measured: After stent removal (1-2 weeks after surgery)
Quantity of Narcotic Use
This is to measure the morbidity associated with the indwelling ureteral stent. It will be reported in milligram morphine equivalents.
Measured: After stent removal (1-2 weeks after surgery)
Number of Emergency Department Visits
This is to measure morbidity associated with the indwelling ureteral stent. Incidence will be collected at study visit.
Measured: After stent removal (1-2 weeks after surgery)
Number of Drug-related Adverse Effects
This is to measure the morbidity of the study drug. Incidence will be self-reported by patients.
Measured: After stent removal (1-2 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start29 Jun 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a 1:1 ratio to receive fexofenadine or placebo in addition to the standard of care. A total of 39 subjects will be randomized to each group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Responsible party
- Principal investigator, Ojas Shah, Columbia University
- Investigators
- Ojas Shah, MD, Principal investigator, Professor of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726345
- Sponsor's protocol ID
- AAAT0219
- Status last verified
- Jul 2025
- First submitted
- 20 Jan 2021
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboutaleb H, Gawish M. Correlation of Bladder Histopathologic Changes Due to Double-J Stenting to the Period of Stenting: A Preliminary Study. J Endourol. 2017 Jul;31(7):705-710. doi: 10.1089/end.2017.0113. Epub 2017 May 31.
PubMed 28467731Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.
PubMed 12576846Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.
PubMed 12576847Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.
PubMed 21453351Lingeman JE, Preminger GM, Goldfischer ER, Krambeck AE; Comfort Study Team. Assessing the impact of ureteral stent design on patient comfort. J Urol. 2009 Jun;181(6):2581-7. doi: 10.1016/j.juro.2009.02.019. Epub 2009 Apr 16.
PubMed 19375088Sivalingam S, Streeper NM, Sehgal PD, Sninsky BC, Best SL, Nakada SY. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial. J Urol. 2016 Feb;195(2):385-90. doi: 10.1016/j.juro.2015.08.104. Epub 2015 Sep 21.
PubMed 26393904Yilmaz E, Batislam E, Deniz T, Yuvanc E. Histamine 1 receptor antagonist in symptomatic treatment of renal colic accompanied by nausea: two birds with one stone? Urology. 2009 Jan;73(1):32-6. doi: 10.1016/j.urology.2008.08.494. Epub 2008 Oct 11.
PubMed 18849063Han DS, Margolin EJ, Movassaghi M, Johnson JP, Chowdhury M, Pingle SR, Schulster ML, Weiner DM, Shah O. Effect of Antihistamine on Ureteral Stent-Related Symptoms: A Double-Blind Randomized Controlled Trial. Urol Pract. 2025 Jul;12(4):415-425. doi: 10.1097/UPJ.0000000000000791. Epub 2025 Feb 12.
PubMed 39937815
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antihistamines on Ureteral Stent-Related Symptoms: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04726345
- Acronym / sponsor ID
- AAAT0219
- Conditions
- Nephrolithiasis
- Keywords
- Antihistamines, Ureteral stent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones. Eligible patients will be randomly and divided into two groups in a 1:1 ratio. Group A will receive fexofenadine 180 mg once daily in addition to standard of care treatment. Group B will receive placebo in addition to standard of care treatment. The routine standard of care treatment will consist of oral non-steroidal anti-inflammatory drugs (NSAIDs).
The primary outcomes of the study are the Ureteral Stent Symptom Questionnaire (USSQ) urinary symptom score and pain score. Secondary outcomes include (i) number of office phone calls due to urinary symptoms; (ii) duration of analgesic use; (iii) duration and quantity of narcotic use; (iv) number of emergency department visits; (v) drug-related adverse effects; (vi) other domains of the USSQ.
Detailed description
Ureteral stents treat ureteral obstruction, allow for passive dilation of the ureter, maintain urine flow to the bladder, and aid in the recovery of the ureter after endoscopic surgery or ureteral injury. These stents are routinely utilized after urologic procedures for the treatment of urolithiasis and are generally kept in place for 1-2 weeks following the procedure. Despite their advantages, indwelling ureteral stents cause discomfort and reduce patient quality of life. These symptoms are partially attributed to local irritation to the ureter and bladder. Bothersome stent-related symptoms include urinary urgency, frequency, flank pain, hematuria, dysuria, sexual side effects, and emotional distress. The majority of patients with ureteral stents experience symptoms post-operatively.
Several studies have indicated that agents such as antimuscarinics or alpha-1 adrenergic receptor antagonists may improve stent-related symptoms. The indications for anticholinergic medications are based on blocking involuntary bladder muscle contraction; however, the efficacy of these drugs is still controversial. Furthermore, these medications have potential adverse side effects.
Antihistamines also show potential in alleviating stent-related symptoms. Multiple in vitro studies have shown H1 receptor activity involved both in ureteral peristalsis and in bladder contraction. Both first- and second-generation H1 antagonists have shown activity in the urinary tract. In clinical practice, antihistamines are commonly utilized in the management of bladder pain caused by interstitial cystitis. Additionally, a randomized controlled trial found efficacy of antihistamines for pain management in the setting of renal colic from obstructing ureteral stones. There is novel evidence that in patients with indwelling stents, there are inflammatory changes in the bladder with an associated eosinophilic reaction. Eosinophilic cystitis is commonly associated with bladder irritation or allergy, and these findings point to a novel paradigm of treating patients with antihistamines. To our knowledge, no studies have evaluated the efficacy of antihistamines for managing stent-related symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a 1:1 ratio to receive fexofenadine or placebo in addition to the standard of care. A total of 39 subjects will be randomized to each group.
| Arm | Type | Receives |
|---|---|---|
| Fexofenadine | Experimental | Drug: Fexofenadine Hcl 180Mg TabParticipants in this arm will receive fexofenadine 180mg once daily, in addition to standard of care pain medications (NSAIDs). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will receive placebo once daily, in addition to standard of care pain medications (NSAIDs). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (aged 18-80 years) who are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones
Key exclusion criteria (9 listed)
- Preoperative use of antihistamines, beta-3 agonists, anticholinergics, corticosteroids, and chronic opioid analgesic use
- Preoperative indwelling ureteral stent at the time of treatment
- Neurogenic bladder, ureteral stricture, interstitial cystitis, or chronic prostatitis
- Pregnancy or breastfeeding
- Planned bilateral ureteroscopy
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 |
|---|---|---|
| Fexofenadine Hcl 180Mg TabAlso: FexofenadineFexofenadine 180mg tablet to be taken orally once a day until stent removal. | Drug | Fexofenadine |
| PlaceboAlso: Placebo TabletPlacebo tablet to be taken orally once a day until stent removal. | Drug | Placebo |
Primary outcome
USSQ Urinary Symptom Score
Time frame: Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)
Ureteric Stent Symptoms Questionnaire (USSQ) is a self-administered questionnaire to evaluate the overall impact of ureteral stents on different aspects of life. Urinary symptom will be assessed at different time points. The urinary symptom section consists of 11 questions. The total score range is 11 to 54 points. Higher scores represent increasing symptom severity.
USSQ Body Pain Score
Time frame: Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)
Ureteric Stent Symptoms Questionnaire (USSQ) is a self-administered questionnaire to evaluate the overall impact of ureteral stents on different aspects of life. Body pain will be assessed at different time points. The body pain section consists of 7 questions. The total score range is 0 to 37 points. Higher scores represent increasing pain.
5 secondary outcomes
Number of Office Phone Calls Due to Urinary Symptoms and Pain
Time frame: After stent removal (1-2 weeks after surgery)
Duration of NSAID Use
Time frame: After stent removal (1-2 weeks after surgery)
Quantity of Narcotic Use
Time frame: After stent removal (1-2 weeks after surgery)
Number of Emergency Department Visits
Time frame: After stent removal (1-2 weeks after surgery)
Number of Drug-related Adverse Effects
Time frame: After stent removal (1-2 weeks after surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28467731Aboutaleb H, Gawish M. Correlation of Bladder Histopathologic Changes Due to Double-J Stenting to the Period of Stenting: A Preliminary Study. J Endourol. 2017 Jul;31(7):705-710. doi: 10.1089/end.2017.0113. Epub 2017 May 31.
- Background: PubMed 12576846Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.
- Background: PubMed 12576847Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.
- Background: PubMed 21453351Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.
- Background: PubMed 19375088Lingeman JE, Preminger GM, Goldfischer ER, Krambeck AE; Comfort Study Team. Assessing the impact of ureteral stent design on patient comfort. J Urol. 2009 Jun;181(6):2581-7. doi: 10.1016/j.juro.2009.02.019. Epub 2009 Apr 16.
- Background: PubMed 26393904Sivalingam S, Streeper NM, Sehgal PD, Sninsky BC, Best SL, Nakada SY. Does Combination Therapy with Tamsulosin and Tolterodine Improve Ureteral Stent Discomfort Compared with Tamsulosin Alone? A Double-Blind, Randomized, Controlled Trial. J Urol. 2016 Feb;195(2):385-90. doi: 10.1016/j.juro.2015.08.104. Epub 2015 Sep 21.
- Background: PubMed 18849063Yilmaz E, Batislam E, Deniz T, Yuvanc E. Histamine 1 receptor antagonist in symptomatic treatment of renal colic accompanied by nausea: two birds with one stone? Urology. 2009 Jan;73(1):32-6. doi: 10.1016/j.urology.2008.08.494. Epub 2008 Oct 11.
- Derived from this study: PubMed 39937815Han DS, Margolin EJ, Movassaghi M, Johnson JP, Chowdhury M, Pingle SR, Schulster ML, Weiner DM, Shah O. Effect of Antihistamine on Ureteral Stent-Related Symptoms: A Double-Blind Randomized Controlled Trial. Urol Pract. 2025 Jul;12(4):415-425. doi: 10.1097/UPJ.0000000000000791. Epub 2025 Feb 12.
- Individual participant dataSharing planned: No
Related trials for Nephrolithiasis
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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. This study is not recruiting at the moment.
Ojas Shah, MD principal investigator
Professor of Urology
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 Fexofenadine Hcl 180Mg Tab in people with Nephrolithiasis, run by Columbia University at 1 site in United States.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jul 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USSQ Urinary Symptom Score (time frame: Baseline, stent in situ immediately before stent removal, and poststent removal (4 to 6-week follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726345, which also lists 8 linked publications.
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 16 Jul 2025.