Disorder of Urinary StentPhase 2/3NCT01530243
The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms
A Phase 2/3 study testing Terazosine, Tolterodine and Tolterodine + Terazosin in people with Disorder of Urinary Stent, run by Urmia University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Disorder of Urinary Stent
- What is being tested?
- Terazosine, Tolterodine and Tolterodine + Terazosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteIran
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 2/3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling.
Who cannot join
- Prior history of pelvic surgery
- Prior history of Transurethral Resection of the either Prostate or Bladder Tumor
- Benign prostate hyperplasia
- Recent or recurrent urinary tract infection
- Chronic medication with beta-blockers or Anti-cholinergic
- Pregnancy
Show all 13Show fewer
- Prostatitis
- Prostate cancer
- Bilateral ureteroscopy or ureteral stenting
- Age < 18 and > 55
- Stone size > 20 mm
- Diabetes
- Bladder Outlet Obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase One of Study on Urinary Stent Complications and Treatment
The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.
Read the detailed description
Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient's comfort.
US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin and tolterodine lonely and together in comparison of placebo on US related symptoms.
The investigators study will be done prospectively. The patients who underwent indwelling Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug's effect on US related symptoms.
- Conditions
- Disorder of Urinary Stent
- Being tested
- Placebo, Terazosine, Tolterodine, Tolterodine + Terazosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Group 1
same as tolterodine and terazosin dose
TerazosineDrug
Also called Group 2
2 mg BID
TolterodineDrug
Also called Group 3
2 mg daily
Tolterodine + TerazosinDrug
Also called Group 4
2mg daily and 2mg BID
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Terazosin | Active comparator | Not described Receives: Drug: Terazosine |
| Tolterodine | Active comparator | Not described Receives: Drug: Tolterodine |
| Tolterodine + Terazosin | Active comparator | Not described Receives: Drug: Tolterodine + Terazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Urinary Tract Symptoms (LUTS)
LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.
Measured: Expected average of 2 weeks
Secondary outcomes (1)
Quality of Life
The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.
Measured: Expected 2 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionSep 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Urinary StentStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Tehranchi, Urologist, Study chair, Urology departmentYousef Rezaei, M.D, Principal investigator, Urmia University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530243
- Sponsor's protocol ID
- UUNRC 01
- Status last verified
- Feb 2015
- First submitted
- 18 Jan 2012
- Last updated
- 2 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tehranchi A, Rezaei Y, Khalkhali H, Rezaei M. Effects of terazosin and tolterodine on ureteral stent related symptoms: a double-blind placebo-controlled randomized clinical trial. Int Braz J Urol. 2013 Nov-Dec;39(6):832-40. doi: 10.1590/S1677-5538.IBJU.2013.06.09.
PubMed 24456787
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase One of Study on Urinary Stent Complications and Treatment
- ClinicalTrials.gov ID
- NCT01530243
- Acronym / sponsor ID
- UUNRC 01
- Conditions
- Disorder of Urinary Stent
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.
Detailed description
Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient's comfort.
US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin and tolterodine lonely and together in comparison of placebo on US related symptoms.
The investigators study will be done prospectively. The patients who underwent indwelling Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug's effect on US related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Terazosin | Active comparator | Drug: Terazosine |
| Tolterodine | Active comparator | Drug: Tolterodine |
| Tolterodine + Terazosin | Active comparator | Drug: Tolterodine + Terazosin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling.
Key exclusion criteria (13 listed)
- Prior history of pelvic surgery
- Prior history of Transurethral Resection of the either Prostate or Bladder Tumor
- Benign prostate hyperplasia
- Recent or recurrent urinary tract infection
- Chronic medication with beta-blockers or Anti-cholinergic
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 |
|---|---|---|
| PlaceboAlso: Group 1same as tolterodine and terazosin dose | Drug | Placebo |
| TerazosineAlso: Group 22 mg BID | Drug | Terazosin |
| TolterodineAlso: Group 32 mg daily | Drug | Tolterodine |
| Tolterodine + TerazosinAlso: Group 42mg daily and 2mg BID | Drug | Tolterodine + Terazosin |
Primary outcome
Lower Urinary Tract Symptoms (LUTS)
Time frame: Expected average of 2 weeks
LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.
1 secondary outcome
Quality of Life
Time frame: Expected 2 weeks later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24456787Tehranchi A, Rezaei Y, Khalkhali H, Rezaei M. Effects of terazosin and tolterodine on ureteral stent related symptoms: a double-blind placebo-controlled randomized clinical trial. Int Braz J Urol. 2013 Nov-Dec;39(6):832-40. doi: 10.1590/S1677-5538.IBJU.2013.06.09.
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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.
Ali Tehranchi, Urologist study chair
Urology department
Yousef Rezaei, M.D principal investigator
Urmia University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Terazosine, Tolterodine and Tolterodine + Terazosin in people with Disorder of Urinary Stent, run by Urmia University of Medical Sciences at 1 site in Iran.
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 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: finished, as of the sponsor's last update on 2 Mar 2015. 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 Iran. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 2 Mar 2015). 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?
Lower Urinary Tract Symptoms (LUTS) (time frame: Expected average of 2 weeks). 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 NCT01530243, which also lists 1 linked publication.
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 2 Mar 2015.