Neurogenic BladderPhase 1/2NCT00602186
Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
A Phase 1/2 study testing tamsolusin and prazosin in people with Neurogenic Bladder, run by Tabriz University.
Trial summary
The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO) Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- tamsolusin and prazosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Mar 2008
- Phase
- Phase 1/2
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy females with voiding difficulty with MFR<12 and post void residual urine>50cc
Who cannot join
- History of pelvic floor surgury during last 3 month
- Any contraindication for Tamsolusin or prazosin
About this study
The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)
Read the detailed description
Voiding dysfunction is not uncommon in Tabriz.About 20% of patients in female urology clinic of Tabriz university of medical sciences sufered from some degrees of voiding dysfunction (due to bladder imparement or bladder outlet obstruction).There is limited information about medical treatment of those patients. On the other hand alpha adrenergic blockers are the first choice medication in BENIGN PROSTATIC HYPERPLASIA. There is some new facts about destribution of alpha adrenergic blockers in female pelvic floor.The purpose of this study is to comparision whether Tamsolusin 0.4/daily or Prazosin 1 mg/daily are effective in the treatment of female voiding dysfunction(BOO)
- Conditions
- Neurogenic Bladder
- Being tested
- tamsolusin, prazosin
- Keywords
- female voiding dysfunction, Tamsolusin, prazosin
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsolusinDrug
Also called Flomax
0.4 mg /day
prazosinDrug
1 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | taking Tamsulosin Receives: Drug: tamsolusin |
| 2 | Active comparator | taking prasosin Receives: Drug: prazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient symptoms improvement(Standard questionare)
Measured: every month untile 3 months
Secondary outcomes (1)
Urodynamics parameters improvement
Measured: three months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJul 2005
- Primary completionMar 2007 (estimated)
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- SAKINEH hajebrahimi, MD, Study director, Urology department ofTabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602186
- Sponsor's protocol ID
- 85-1
- Status last verified
- Jan 2008
- First submitted
- 18 Apr 2007
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
- ClinicalTrials.gov ID
- NCT00602186
- Acronym / sponsor ID
- 85-1
- Conditions
- Neurogenic Bladder
- Keywords
- female voiding dysfunction, Tamsolusin, prazosin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2007 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 28 Jan 2008 (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.
The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)
Detailed description
Voiding dysfunction is not uncommon in Tabriz.About 20% of patients in female urology clinic of Tabriz university of medical sciences sufered from some degrees of voiding dysfunction (due to bladder imparement or bladder outlet obstruction).There is limited information about medical treatment of those patients. On the other hand alpha adrenergic blockers are the first choice medication in BENIGN PROSTATIC HYPERPLASIA. There is some new facts about destribution of alpha adrenergic blockers in female pelvic floor.The purpose of this study is to comparision whether Tamsolusin 0.4/daily or Prazosin 1 mg/daily are effective in the treatment of female voiding dysfunction(BOO)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tamsolusintaking Tamsulosin |
| 2 | Active comparator | Drug: prazosintaking prasosin |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy females with voiding difficulty with MFR<12 and post void residual urine>50cc
Key exclusion criteria (2 listed)
- History of pelvic floor surgury during last 3 month
- Any contraindication for Tamsolusin or prazosin
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 |
|---|---|---|
| tamsolusinAlso: Flomax0.4 mg /day | Drug | 1 |
| prazosin1 mg/day | Drug | 2 |
Primary outcome
patient symptoms improvement(Standard questionare)
Time frame: every month untile 3 months
1 secondary outcome
Urodynamics parameters improvement
Time frame: three months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
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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.
SAKINEH hajebrahimi, MD study director
Urology department ofTabriz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tamsolusin and prazosin in people with Neurogenic Bladder, run by Tabriz University.
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 2 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 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
patient symptoms improvement(Standard questionare) (time frame: every month untile 3 months). 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 29 Jan 2008.