Ureteral Stent DiscomfortPhase 3NCT00467467
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort
A Phase 3 study testing Alfuzosin Hydrochloride in people with Ureteral Stent Discomfort, run by University of Minnesota at 1 site in United States.
Trial summary
To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stent Discomfort
- What is being tested?
- Alfuzosin Hydrochloride
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Undergoing unilateral retrograde ureteroscopy with ureteral stent placement
Who cannot join
- Significant ureteral trauma
- Concomitant ESWL or other secondary surgical procedure than may impact patient comfort
- Subject with know hypersensitivity to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets.
- Pregnancy, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study
- Undergoing bilateral ureteral stenting
- Undergoing antegrade ureteral stenting
Show all 14Show fewer
- Undergoing simultaneous extracorporeal shockwave lithotripsy
- Urinary infection (fever >101, positive urine culture, many bacteria on urinalysis)
- Primary bladder dysfunction that would impact ability to void without a catheter
- Neurologic dysfunction that would impair pain sensation
- History of chronic pain or substance abuse
- Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased
- Other alpha-blockers
- Phosphodiesterase type 5 inhibitors for erectile function Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.
- Conditions
- Ureteral Stent Discomfort
- Being tested
- Alfuzosin Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin HydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of study medication on urinary symptoms and quality of life
usage of analgesics/narcotics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startJun 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent DiscomfortStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Manoj Monga, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467467
- Sponsor's protocol ID
- 0512M78807
- Status last verified
- May 2013
- First submitted
- 27 Apr 2007
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort
- ClinicalTrials.gov ID
- NCT00467467
- Acronym / sponsor ID
- 0512M78807
- Conditions
- Ureteral Stent Discomfort
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 30 Apr 2007 (estimated)
- 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.
To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18
- Undergoing unilateral retrograde ureteroscopy with ureteral stent placement
Key exclusion criteria (14 listed)
- Significant ureteral trauma
- Concomitant ESWL or other secondary surgical procedure than may impact patient comfort
- Subject with know hypersensitivity to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets.
- Pregnancy, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study
- Undergoing bilateral ureteral stenting
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 |
|---|---|---|
| Alfuzosin Hydrochloride | Drug | – |
Primary outcome
effect of study medication on urinary symptoms and quality of life
usage of analgesics/narcotics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
Related trials for Ureteral Stent Discomfort
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
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.
Manoj Monga, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfuzosin Hydrochloride in people with Ureteral Stent Discomfort, run by University of Minnesota 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 2 inclusion and 14 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 30 May 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effect of study medication on urinary symptoms and quality of life. 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?
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 30 May 2013.