Ureteral DiseasesPhase 4NCT03799120
Daily Versus Twice Per Day Tamsulosin for Ureteral Stent Symptoms
A Phase 4 study testing Tamsulosin BID in people with Ureteral Diseases, run by Gundersen Lutheran Medical Foundation at 1 site in United States.
Trial summary
A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ureteral Diseases
- What is being tested?
- Tamsulosin BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 70 years old.
- Planning to undergo ureteroscopy with ureteral stent placement at our site.
- Able to read and understand an English language survey (USSQ).
Who cannot join
- Patients who are unable to provide informed consent.
- Patients who are already taking an alpha-blocker.
- Patients with hypersensitivity or known adverse side effects of tamsulosin or its ingredients and those who are not candidates for tamsulosin per attending Urologist discretion.
- Patients with a preexisting bladder condition including UTI within 30 days of the procedure.
- Patients with hepatitis C on boceprevir.
- Patients who have medical conditions known to be associated with chronic pain, those taking medications for chronic pain such as gabapentin or a chronic opioid per the judgement of the PI, or those with a pain contract on file.
- Women who are pregnant or planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis
A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.
Read the detailed description
Ureteral stents are commonly used to maintain patency of the ureter and are placed for several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been associated with significant discomfort and dissatisfaction among patients.5 Bosio and colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over 90% of patients reported that this pain interfered with their everyday life.
The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures several domains relating to stent pain including general health, urinary issues, pain, work performance, sexual matters, and quality of life with stent in situ. The USSQ has been validated and translated and is currently a widely used measure.
While commonly used for treatment of benign prostatic hyperplasia, several studies have evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores and 7.2 in body pain scores). To date, randomized controlled trials have used one of two types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for lower urinary tract symptoms for patients with an indwelling stent. No study to date, however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on stent-related symptoms. The objective of this study is to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort.
- Conditions
- Ureteral Diseases
- Being tested
- Tamsulosin BID, Placebo
- Medical subject headings
- Ureteral Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin BIDDrug
comparison of once daily versus twice daily tamsulosin
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| tamsulosin QD + Placebo | Placebo comparator | 0.4 mg tamsulosin QD + Placebo QD Receives: Drug: Tamsulosin BID; Other: Placebo |
| tamsulosin BID | Experimental | 0.4 mg tamsulosin BID Receives: Drug: Tamsulosin BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteric Stent Symptoms Questionnaire
Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.
Measured: 1 week post-stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start18 Feb 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ureteral DiseasesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gundersen Lutheran Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Kallies, Gundersen Lutheran Medical Foundation
- Investigators
- Matthew Ferroni, MD, Principal investigator, Gundersen Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799120
- Sponsor's protocol ID
- 2-18-11-001
- Status last verified
- Feb 2019
- First submitted
- 4 Jan 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23.
PubMed 27125392Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19.
PubMed 29923014Joshi 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 12576846Lamb 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 21453351Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29.
PubMed 27809592
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis
- ClinicalTrials.gov ID
- NCT03799120
- Acronym / sponsor ID
- 2-18-11-001
- Conditions
- Ureteral Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gundersen Lutheran Medical FoundationUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Jan 2019 (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.
A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.
Detailed description
Ureteral stents are commonly used to maintain patency of the ureter and are placed for several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been associated with significant discomfort and dissatisfaction among patients.5 Bosio and colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over 90% of patients reported that this pain interfered with their everyday life.
The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures several domains relating to stent pain including general health, urinary issues, pain, work performance, sexual matters, and quality of life with stent in situ. The USSQ has been validated and translated and is currently a widely used measure.
While commonly used for treatment of benign prostatic hyperplasia, several studies have evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores and 7.2 in body pain scores). To date, randomized controlled trials have used one of two types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for lower urinary tract symptoms for patients with an indwelling stent. No study to date, however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on stent-related symptoms. The objective of this study is to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamsulosin QD + Placebo | Placebo comparator | Drug: Tamsulosin BID, Other: Placebo0.4 mg tamsulosin QD + Placebo QD |
| tamsulosin BID | Experimental | Drug: Tamsulosin BID0.4 mg tamsulosin BID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18 and 70 years old.
- Planning to undergo ureteroscopy with ureteral stent placement at our site.
- Able to read and understand an English language survey (USSQ).
Key exclusion criteria (7 listed)
- Patients who are unable to provide informed consent.
- Patients who are already taking an alpha-blocker.
- Patients with hypersensitivity or known adverse side effects of tamsulosin or its ingredients and those who are not candidates for tamsulosin per attending Urologist discretion.
- Patients with a preexisting bladder condition including UTI within 30 days of the procedure.
- Patients with hepatitis C on boceprevir.
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 |
|---|---|---|
| Tamsulosin BIDcomparison of once daily versus twice daily tamsulosin | Drug | tamsulosin BID, tamsulosin QD + Placebo |
| PlaceboPlacebo | Other | tamsulosin QD + Placebo |
Primary outcome
Ureteric Stent Symptoms Questionnaire
Time frame: 1 week post-stent placement
Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Background: PubMed 27125392Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23.
- Background: PubMed 29923014Bosio A, Alessandria E, Dalmasso E, Peretti D, Agosti S, Bisconti A, Destefanis P, Passera R, Gontero P. How bothersome double-J ureteral stents are after semirigid and flexible ureteroscopy: a prospective single-institution observational study. World J Urol. 2019 Jan;37(1):201-207. doi: 10.1007/s00345-018-2376-6. Epub 2018 Jun 19.
- 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 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 27809592Dellis AE, Papatsoris AG, Keeley FX Jr, Bamias A, Deliveliotis C, Skolarikos AA. Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study. J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Matthew Ferroni, MD principal investigator
Gundersen Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin BID in people with Ureteral Diseases, run by Gundersen Lutheran Medical Foundation 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Feb 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Ureteric Stent Symptoms Questionnaire (time frame: 1 week post-stent placement). 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 NCT03799120, which also lists 5 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 25 Feb 2019.