Overactive Bladder Associated With HTLV-1Phase 1NCT01640002
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
A Phase 1 study testing Propantheline Bromide in people with Overactive Bladder Associated With HTLV-1, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
Trial summary
It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients. We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Associated With HTLV-1
- What is being tested?
- Propantheline Bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Apr 2013
- Phase
- Phase 1
- 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
- HTLV-1 infection
- More than 18 years
- Negative urine culture
- No neurological damage
Who cannot join
- Diabetes
- Persistently positive urine culture
- Pelvic, head, urological or gynecological surgery
- Stroke
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Service of Imunology - Universitary Hospital Prof. Edgard Santos
Salvador, Estado de Bahia, 40110-070
José Abraão Carneiro Neto, 557132838392, abraao.neto@gmail.com
Edgard Marcelino Carvalho Filho, imuno@ufba.br
About this study
It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients.
We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent.
Read the detailed description
Double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients
Treatment Group Propantheline Bromide: 15mg, three times daily for 08 weeks.
Control Group Placebo 03 times daily
Case definition Clinically defined OAB patients (ICS criteria), infected by HTLV-1. Frequency was defined as more than 08 daytime voids. Nocturia was defined as more than 02 voids after sleeping.
Inclusion criteria More than 18 year. HTLV-1 infected patients with overactive bladder. Negative culture of urine. Without neurological impairment.
Exclusion criteria Persistently positive urine culture
History of:
Allergy to medication, head or spinal trauma. Head and neck, neurological,spinal, lower abdominal or pelvic surgery. Stroke. Users of urinary catheters.
- Being tested
- Propantheline Bromide, Placebo
- Keywords
- overactive bladder, HTLV-1, Propantheline, anticholinergic
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propantheline BromideDrug
15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
PlaceboDrug
PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS
| Study group | Role | What they receive |
|---|---|---|
| Propantheline | Active comparator | Not described Receives: Drug: Propantheline Bromide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve in Overactive bladder symptoms score
Measured: 2 months
Secondary outcomes (1)
Improvement in nocturia and urgency
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder Associated With HTLV-1Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Abraao Carneiro Neto, Hospital Universitário Professor Edgard Santos
- Investigators
- José Abraão Carneiro Neto, Principal investigator, Service of Imunology - Universitary Hospital Prof. Edgard Santos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640002
- Sponsor's protocol ID
- FR-473218
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rocha PN, Rehem AP, Santana JF, Castro N, Muniz AL, Salgado K, Rocha H, Carvalho EM. The cause of urinary symptoms among Human T Lymphotropic Virus Type I (HLTV-I) infected patients: a cross sectional study. BMC Infect Dis. 2007 Mar 12;7:15. doi: 10.1186/1471-2334-7-15.
PubMed 17352816Poetker SK, Porto AF, Giozza SP, Muniz AL, Caskey MF, Carvalho EM, Glesby MJ. Clinical manifestations in individuals with recent diagnosis of HTLV type I infection. J Clin Virol. 2011 May;51(1):54-8. doi: 10.1016/j.jcv.2011.02.004. Epub 2011 Mar 8.
PubMed 21388871Caskey MF, Morgan DJ, Porto AF, Giozza SP, Muniz AL, Orge GO, Travassos MJ, Barron Y, Carvalho EM, Glesby MJ. Clinical manifestations associated with HTLV type I infection: a cross-sectional study. AIDS Res Hum Retroviruses. 2007 Mar;23(3):365-71. doi: 10.1089/aid.2006.0140.
PubMed 17411369Gomes I, Melo A, Proietti FA, Moreno-Carvalho O, Loures LA, Dazza MC, Said G, Larouze B, Galvao-Castro B. Human T lymphotropic virus type I (HTLV-I) infection in neurological patients in Salvador, Bahia, Brazil. J Neurol Sci. 1999 May 1;165(1):84-9. doi: 10.1016/s0022-510x(99)00083-0.
PubMed 10426153Garlet GP, Giozza SP, Silveira EM, Claudino M, Santos SB, Avila-Campos MJ, Martins W Jr, Cardoso CR, Trombone AP, Campanelli AP, Carvalho EM, Silva JS. Association of human T lymphotropic virus 1 amplification of periodontitis severity with altered cytokine expression in response to a standard periodontopathogen infection. Clin Infect Dis. 2010 Feb 1;50(3):e11-8. doi: 10.1086/649871.
PubMed 20038241Tannus M, Tanajura D, Sundberg MA, Oliveira P, Castro N, Santos AM. Detrusor Arreflexia as an End Stage of Neurogenic Bladder in HAM/TSP? Case Rep Med. 2011;2011:289389. doi: 10.1155/2011/289389. Epub 2011 Apr 13.
PubMed 21541226Thuroff JW, Bunke B, Ebner A, Faber P, de Geeter P, Hannappel J, Heidler H, Madersbacher H, Melchior H, Schafer W, et al. Randomized, double-blind, multicenter trial on treatment of frequency, urgency and incontinence related to detrusor hyperactivity: oxybutynin versus propantheline versus placebo. J Urol. 1991 Apr;145(4):813-6; discussion 816-7. doi: 10.1016/s0022-5347(17)38459-8.
PubMed 2005707Gotoh M, Homma Y, Yokoyama O, Nishizawa O. Responsiveness and minimal clinically important change in overactive bladder symptom score. Urology. 2011 Oct;78(4):768-73. doi: 10.1016/j.urology.2011.06.020.
PubMed 21855969Castro NM, Rodrigues W Jr, Freitas DM, Muniz A, Oliveira P, Carvalho EM. Urinary symptoms associated with human T-cell lymphotropic virus type I infection: evidence of urinary manifestations in large group of HTLV-I carriers. Urology. 2007 May;69(5):813-8. doi: 10.1016/j.urology.2007.01.052.
PubMed 17482910Oliveira P, Castro NM, Muniz AL, Tanajura D, Brandao JC, Porto AF, Carvalho EM. Prevalence of erectile dysfunction in HTLV-1-infected patients and its association with overactive bladder. Urology. 2010 May;75(5):1100-3. doi: 10.1016/j.urology.2009.11.041. Epub 2010 Feb 26.
PubMed 20189229
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT01640002
- Acronym / sponsor ID
- FR-473218
- Keywords
- overactive bladder, HTLV-1, Propantheline, anticholinergic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 13 Jul 2012 (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.
It's a double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients.
We think that the treatment of the OAB with Propantheline could reduce nocturia and frequency in sixty percent.
Detailed description
Double blind, placebo controlled study to assess the efficacy of Propantheline Bromide to treat overactive bladder (OAB) in HTLV 1 infected patients
Treatment Group Propantheline Bromide: 15mg, three times daily for 08 weeks.
Control Group Placebo 03 times daily
Case definition Clinically defined OAB patients (ICS criteria), infected by HTLV-1. Frequency was defined as more than 08 daytime voids. Nocturia was defined as more than 02 voids after sleeping.
Inclusion criteria More than 18 year. HTLV-1 infected patients with overactive bladder. Negative culture of urine. Without neurological impairment.
Exclusion criteria Persistently positive urine culture
History of:
Allergy to medication, head or spinal trauma. Head and neck, neurological,spinal, lower abdominal or pelvic surgery. Stroke. Users of urinary catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propantheline | Active comparator | Drug: Propantheline Bromide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HTLV-1 infection
- More than 18 years
- Negative urine culture
- No neurological damage
Key exclusion criteria (4 listed)
- Diabetes
- Persistently positive urine culture
- Pelvic, head, urological or gynecological surgery
- Stroke
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 |
|---|---|---|
| Propantheline Bromide15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS. | Drug | Propantheline |
| PlaceboPLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS | Drug | Placebo |
Primary outcome
Improve in Overactive bladder symptoms score
Time frame: 2 months
1 secondary outcome
Improvement in nocturia and urgency
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Background: PubMed 17352816Rocha PN, Rehem AP, Santana JF, Castro N, Muniz AL, Salgado K, Rocha H, Carvalho EM. The cause of urinary symptoms among Human T Lymphotropic Virus Type I (HLTV-I) infected patients: a cross sectional study. BMC Infect Dis. 2007 Mar 12;7:15. doi: 10.1186/1471-2334-7-15.
- Background: PubMed 21388871Poetker SK, Porto AF, Giozza SP, Muniz AL, Caskey MF, Carvalho EM, Glesby MJ. Clinical manifestations in individuals with recent diagnosis of HTLV type I infection. J Clin Virol. 2011 May;51(1):54-8. doi: 10.1016/j.jcv.2011.02.004. Epub 2011 Mar 8.
- Background: PubMed 17411369Caskey MF, Morgan DJ, Porto AF, Giozza SP, Muniz AL, Orge GO, Travassos MJ, Barron Y, Carvalho EM, Glesby MJ. Clinical manifestations associated with HTLV type I infection: a cross-sectional study. AIDS Res Hum Retroviruses. 2007 Mar;23(3):365-71. doi: 10.1089/aid.2006.0140.
- Background: PubMed 10426153Gomes I, Melo A, Proietti FA, Moreno-Carvalho O, Loures LA, Dazza MC, Said G, Larouze B, Galvao-Castro B. Human T lymphotropic virus type I (HTLV-I) infection in neurological patients in Salvador, Bahia, Brazil. J Neurol Sci. 1999 May 1;165(1):84-9. doi: 10.1016/s0022-510x(99)00083-0.
- Background: PubMed 20038241Garlet GP, Giozza SP, Silveira EM, Claudino M, Santos SB, Avila-Campos MJ, Martins W Jr, Cardoso CR, Trombone AP, Campanelli AP, Carvalho EM, Silva JS. Association of human T lymphotropic virus 1 amplification of periodontitis severity with altered cytokine expression in response to a standard periodontopathogen infection. Clin Infect Dis. 2010 Feb 1;50(3):e11-8. doi: 10.1086/649871.
- Background: PubMed 21541226Tannus M, Tanajura D, Sundberg MA, Oliveira P, Castro N, Santos AM. Detrusor Arreflexia as an End Stage of Neurogenic Bladder in HAM/TSP? Case Rep Med. 2011;2011:289389. doi: 10.1155/2011/289389. Epub 2011 Apr 13.
- Background: PubMed 2005707Thuroff JW, Bunke B, Ebner A, Faber P, de Geeter P, Hannappel J, Heidler H, Madersbacher H, Melchior H, Schafer W, et al. Randomized, double-blind, multicenter trial on treatment of frequency, urgency and incontinence related to detrusor hyperactivity: oxybutynin versus propantheline versus placebo. J Urol. 1991 Apr;145(4):813-6; discussion 816-7. doi: 10.1016/s0022-5347(17)38459-8.
- Background: PubMed 21855969Gotoh M, Homma Y, Yokoyama O, Nishizawa O. Responsiveness and minimal clinically important change in overactive bladder symptom score. Urology. 2011 Oct;78(4):768-73. doi: 10.1016/j.urology.2011.06.020.
- Results publication: PubMed 17482910Castro NM, Rodrigues W Jr, Freitas DM, Muniz A, Oliveira P, Carvalho EM. Urinary symptoms associated with human T-cell lymphotropic virus type I infection: evidence of urinary manifestations in large group of HTLV-I carriers. Urology. 2007 May;69(5):813-8. doi: 10.1016/j.urology.2007.01.052.
- Results publication: PubMed 20189229Oliveira P, Castro NM, Muniz AL, Tanajura D, Brandao JC, Porto AF, Carvalho EM. Prevalence of erectile dysfunction in HTLV-1-infected patients and its association with overactive bladder. Urology. 2010 May;75(5):1100-3. doi: 10.1016/j.urology.2009.11.041. Epub 2010 Feb 26.
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.
José Abraão Carneiro Neto principal investigator
Service of Imunology - Universitary Hospital Prof. Edgard Santos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propantheline Bromide in people with Overactive Bladder Associated With HTLV-1, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
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 4 inclusion and 4 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 13 Jul 2012. 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 Brazil. 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 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.
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?
Contact Jose Abraão Carneiro Neto (55+71+8149-1252, abraao.neto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve in Overactive bladder symptoms score (time frame: 2 months). 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 NCT01640002, which also lists 10 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 13 Jul 2012.