Lower Urinary Tract SymptomsPhase 4HyTa StentNCT03750656
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
A Phase 4 study testing Hyoscyamine and Tamsulosin in people with Lower Urinary Tract Symptoms, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Hyoscyamine and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 31 Aug 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older
- Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma
- Patient must agree to abstain from other clinical studies during the study period
Who cannot join
- Patients younger than 18 years of age
- Patients with chronic or pre-existing indwelling stents
- Patients currently receiving anticholinergic or alpha blocker therapy
- Patients with chronic opioid or analgesic usage
- Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia
- Patients with an active untreated urinary tract infection
Show all 13Show fewer
- Patients who are currently pregnant or nursing
- Patients with allergies or contraindication to either tamsulosin or hyoscyamine
- Patients on active chemotherapy
- Patients currently receiving other investigational therapy
- Patients who are unable to sign consent/answer questionnaire due to compromised mental capacity or language barrier (the questionnaire is not validated in other languages)
- Patients who have a stent placed emergently for an obstructing stone or septic stone without immediate stone removal,
- Any stents placed that will stay in for longer than 2 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents.
Read the detailed description
Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary system. Many studies have looked at methods to reduce these uncomfortable symptoms ranging from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is often the cause of their removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help control stent-related discomfort compared to the tamsulosin arm.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Hyoscyamine, Tamsulosin
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyoscyamineDrug
Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
TamsulosinDrug
Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent
| Study group | Role | What they receive |
|---|---|---|
| Hyoscyamine | Active comparator | Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort Receives: Drug: Hyoscyamine |
| Tamsulosin | Active comparator | 0.4 mg tab orally daily Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral Stent Symptom Questionnaire Score
To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).
Measured: Three Years
Secondary outcomes (2)
Additional Medication Needed
To determine if there is a difference between the amount of additional medications needed to treat stent related discomfort between patients receiving hyoscyamine versus those that receive tamsulosin
Measured: Three Years
Factors That Determine if Additional Medication Needed
To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort
Measured: Three Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start12 Nov 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Not accruing patients quickly enough
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.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized open-blind clinical trial
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Duchene, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750656
- Sponsor's protocol ID
- HSC 142994
- Acronym
- HyTa Stent
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2018
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
- ClinicalTrials.gov ID
- NCT03750656
- Acronym / sponsor ID
- HyTa Stent / HSC 142994
- Conditions
- Lower Urinary Tract Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not accruing patients quickly enough
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents.
Detailed description
Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary system. Many studies have looked at methods to reduce these uncomfortable symptoms ranging from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is often the cause of their removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help control stent-related discomfort compared to the tamsulosin arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hyoscyamine | Active comparator | Drug: HyoscyamineHyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort |
| Tamsulosin | Active comparator | Drug: Tamsulosin0.4 mg tab orally daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be 18 years of age or older
- Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma
- Patient must agree to abstain from other clinical studies during the study period
Key exclusion criteria (13 listed)
- Patients younger than 18 years of age
- Patients with chronic or pre-existing indwelling stents
- Patients currently receiving anticholinergic or alpha blocker therapy
- Patients with chronic opioid or analgesic usage
- Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia
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 |
|---|---|---|
| HyoscyaminePatients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent | Drug | Hyoscyamine |
| TamsulosinPatients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent | Drug | Tamsulosin |
Primary outcome
Ureteral Stent Symptom Questionnaire Score
Time frame: Three Years
To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).
2 secondary outcomes
Additional Medication Needed
Time frame: Three Years
Factors That Determine if Additional Medication Needed
Time frame: Three Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyoscyamine and Tamsulosin in people with Lower Urinary Tract Symptoms, run by University of Kansas Medical Center 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 13 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: stopped early, as of the sponsor's last update on 3 Dec 2024. 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. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2024). 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?
Ureteral Stent Symptom Questionnaire Score (time frame: Three Years). 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 3 Dec 2024.