Bladder Outlet ObstructionPhase 4ToviazNCT00605319
An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia
A Phase 4 study testing Toviaz (Fesoterodine) in people with Bladder Outlet Obstruction, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study. Read more about this study
- Who is it for?
- Ages 40 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Outlet Obstruction
- What is being tested?
- Toviaz (Fesoterodine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2013
- 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 40 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male ≥40 years of age
- Clinical signs and symptoms of frequency and urgency, enlarged prostate and urodynamic study consistent with overactive bladder.
- IPSS >12, with IPSS QoL > 3 at screening visit.
- Ability and willingness to correctly complete the micturition diary and all the trial related questionnaires comply with scheduled visits and comply with trial procedures.
- Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.
- Procedure to treat BOO by TURP or PVP greater than or equal to 1 month ago.
Who cannot join
- A known history of interstitial cystitis, uninvestigated hematuria, or bladder outlet obstruction due to: mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
- Evidence of Urinary Tract Infection according to local standard of care.
- Expectation of initiating treatment during the duration of this study with - any drug treatment for OAB, any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects.
- Use of any electrostimulation within the 30 days before randomization, or the expectation to initiate such therapy during the study.
- Any condition which, in the opinion of the investigator, makes the patient unstable, or with contraindications for inclusion, e.g., uncontrolled narrow-angled glaucoma, urinary retention, preplanned prostate surgery, or gastric retention.
- Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine.
Show all 11Show fewer
- Use of any other investigational drug in the 2 months preceding visit 1.
- History of postural hypotension or syncope in the judgement of the investigator based on local standards of care.
- Alcohol and/or any other drug abuse in the opinion of the investigator.
- Medications such as erythromycin, Biaxin (Clarithromycin), Sporanox (itraconazole), Nizoral (ketoconazole), Neoral and Sandimmune (cyclosporine), Velban (vinblastine) and miconazole.
- Non-medication treatments such as bio-feedback or other bladder training exercises.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Hospital, Cornell University
New York, New York, 10065
About this study
Official title: An Open Label Study to Measure the Efficacy of Fesoterodine (Toviaz) on Continued Detrusor Overactivity in Patients That Have Undergone Treatment for Bladder Outlet Obstruction
The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study.
Read the detailed description
Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment of the obstruction (transurethral resection of the prostate). These patients are usually started empirically on alpha-blockers or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and latter, to treat overactive bladder. We hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as long acting Fesoterodine or Toviaz.
Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on symptoms of patients with bladder outlet obstruction and overactive bladder. In addition, anticholinergic drug Toviaz is not associated with increased incidence of complication like acute urinary retention, a state where patient is unable to empty the bladder as an adverse effect of the drug.
A large proportion of our patients that are undergoing treatment for bladder outlet obstruction also have overactive bladder. We propose an open label trial to evaluate the efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. Toviaz is an antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with overactive bladder on urodynamic test preoperatively will be considered. If these patients continue to have symptoms at the one-month post-operative visit, they will be enrolled into the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, we will see if there is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7 months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and complications. An FDA approved flexible dosing regimen will be allowed for the duration of the study.
- Conditions
- Bladder Outlet Obstruction
- Being tested
- Toviaz (Fesoterodine)
- Keywords
- BPH, BOO
- Medical subject headings
- Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toviaz (Fesoterodine)Drug
Also called Toviaz
4mg to 8mg by mouth once daily
| Study group | Role | What they receive |
|---|---|---|
| Toviaz (Fesoterodine) | Other | Toviaz 4mg to 8mg Receives: Drug: Toviaz (Fesoterodine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS Obstructive
International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with obstructive symptoms which includes hesitancy or difficulty initiating the stream, straining to void, a reduced flow, an intermittent stream or a sensation of incomplete emptying.
Measured: screening (Month 0), 2-months, 3-months, 7-months
IPSS Irritative
International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with irritative symptoms which includes frequency, urgency, nocturia and urge incontinence
Measured: screening (Month 0), 2-months, 3-months, 7-months
IPSS Nocturia
International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with nocturia meaning individuals who wake up during sleeping hours to urinate.
Measured: screening (Month 0), 2-months, 3-months, 7-months
International Prostate Symptom Score (IPSS) Quality of Life (QoL)
IPSS Quality of Life (QoL) is one question used to assess how the patient's symptoms affect their quality of life. A score ranges from 1 to 6, with 6 being the worse outcome.
Measured: screening (Month 0), 2-months, 3-months, 7-months
Maximum Flow Rate (Qmax)
Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary
Measured: screening (Month 0), 2-months, 3-months, 7-months
Average Flow Rate (Qavg)
Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time
Measured: screening (Month 0), 2-months, 3-months, 7-months
Postvoid Residual Volume (PVR)
Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.
Measured: screening (Month 0), 2-months, 3-months, 7-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
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 Bladder Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Alexis Te, MD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605319
- Sponsor's protocol ID
- 0506007934
- Other IDs
- 2005-0202
- Acronym
- Toviaz
- Status last verified
- Mar 2018
- First submitted
- 18 Jan 2008
- Last updated
- 10 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Measure the Efficacy of Fesoterodine (Toviaz) on Continued Detrusor Overactivity in Patients That Have Undergone Treatment for Bladder Outlet Obstruction
- ClinicalTrials.gov ID
- NCT00605319
- Acronym / sponsor ID
- Toviaz / 0506007934
- Conditions
- Bladder Outlet Obstruction
- Keywords
- BPH, BOO
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 10 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subjects who have symptoms of overactive bladder (many trips to the bathroom, and urgency with or without the inability to hold your urine until you get to the toilet) are invited to participate in this research study.
Detailed description
Overactive bladder is a common sequelae of long-term bladder outlet obstruction in men. Unfortunately, it does not often resolve after treatment of the obstruction (transurethral resection of the prostate). These patients are usually started empirically on alpha-blockers or occasionally anticholinergic agents, former used to treat enlarged prostate medically, and latter, to treat overactive bladder. We hypothesize that these patients would be significantly improved with a long-acting anticholinergic agent such as long acting Fesoterodine or Toviaz.
Earlier studies have shown that anticholinergic drugs seem to have a beneficial effect on symptoms of patients with bladder outlet obstruction and overactive bladder. In addition, anticholinergic drug Toviaz is not associated with increased incidence of complication like acute urinary retention, a state where patient is unable to empty the bladder as an adverse effect of the drug.
A large proportion of our patients that are undergoing treatment for bladder outlet obstruction also have overactive bladder. We propose an open label trial to evaluate the efficacy of Toviaz (fesoterodine) 4mg to 8 mg in patients that have continued symptoms of overactive bladder one month following transurethral resection of the prostate. Toviaz is an antimuscarinic and anticholinergic agent, and is a newer formulation of Detrol. Patients with overactive bladder on urodynamic test preoperatively will be considered. If these patients continue to have symptoms at the one-month post-operative visit, they will be enrolled into the study. We expect a total of 25 patients to be enrolled within 4 months. All patients will receive Toviaz 4mg to 8 mg. The patients will be followed at 3 months post-op, 4 months post-op, and 7 months post-op. At each post-op visit, the patients will fill out an AUA symptom score questionnaire, have noninvasive uroflowmetry performed, and have a post-void residual measured by bladder scan. Using standard statistical analysis, we will see if there is a difference in symptoms, post-void residual, or maximum flow rate between baseline and 7 months post-op. We will continue the study to evaluate long-term efficacy, dropout rate, and complications. An FDA approved flexible dosing regimen will be allowed for the duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toviaz (Fesoterodine) | Other | Drug: Toviaz (Fesoterodine)Toviaz 4mg to 8mg |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male ≥40 years of age
- Clinical signs and symptoms of frequency and urgency, enlarged prostate and urodynamic study consistent with overactive bladder.
- IPSS >12, with IPSS QoL > 3 at screening visit.
- Ability and willingness to correctly complete the micturition diary and all the trial related questionnaires comply with scheduled visits and comply with trial procedures.
- Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.
Key exclusion criteria (11 listed)
- A known history of interstitial cystitis, uninvestigated hematuria, or bladder outlet obstruction due to: mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis of urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
- Evidence of Urinary Tract Infection according to local standard of care.
- Expectation of initiating treatment during the duration of this study with - any drug treatment for OAB, any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects.
- Use of any electrostimulation within the 30 days before randomization, or the expectation to initiate such therapy during the study.
- Any condition which, in the opinion of the investigator, makes the patient unstable, or with contraindications for inclusion, e.g., uncontrolled narrow-angled glaucoma, urinary retention, preplanned prostate surgery, or gastric retention.
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 |
|---|---|---|
| Toviaz (Fesoterodine)Also: Toviaz4mg to 8mg by mouth once daily | Drug | Toviaz (Fesoterodine) |
Primary outcome
IPSS Obstructive
Time frame: screening (Month 0), 2-months, 3-months, 7-months
International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with obstructive symptoms which includes hesitancy or difficulty initiating the stream, straining to void, a reduced flow, an intermittent stream or a sensation of incomplete emptying.
IPSS Irritative
Time frame: screening (Month 0), 2-months, 3-months, 7-months
International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with irritative symptoms which includes frequency, urgency, nocturia and urge incontinence
IPSS Nocturia
Time frame: screening (Month 0), 2-months, 3-months, 7-months
International Prostate Symptom Score (IPSS) -is a 7 point scale used to screen, track and manage symptoms associated with BPH for obstructive, irritative, nocturia. The symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Scores range from 1 to 5 for a total of maximum 35 points (0-7 Mildly symptomatic, 8-19 Moderately symptomatic, 20-35 Severely symptomatic). This measure was taken for patients with nocturia meaning individuals who wake up during sleeping hours to urinate.
International Prostate Symptom Score (IPSS) Quality of Life (QoL)
Time frame: screening (Month 0), 2-months, 3-months, 7-months
IPSS Quality of Life (QoL) is one question used to assess how the patient's symptoms affect their quality of life. A score ranges from 1 to 6, with 6 being the worse outcome.
Maximum Flow Rate (Qmax)
Time frame: screening (Month 0), 2-months, 3-months, 7-months
Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary
Average Flow Rate (Qavg)
Time frame: screening (Month 0), 2-months, 3-months, 7-months
Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time
Postvoid Residual Volume (PVR)
Time frame: screening (Month 0), 2-months, 3-months, 7-months
Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share data
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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.
Alexis Te, MD principal investigator
Cornell University
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 Toviaz (Fesoterodine) in people with Bladder Outlet Obstruction, run by Weill Medical College of Cornell University 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 6 inclusion and 11 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 10 Apr 2018. 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 10 Apr 2018). 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?
IPSS Obstructive (time frame: screening (Month 0), 2-months, 3-months, 7-months). The study lists 7 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 10 Apr 2018.