A Phase 4 interventional study of Toviaz (Fesoterodine) in Bladder Outlet Obstruction, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to male participants aged 40 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment
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.
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.
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's enrollment of 17 is below the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients will be selected by the investigator and sub-investigator's patient population, and physician referrals. All patients will meet the inclusion/ exclusion criteria.
Inclusion Criteria
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Toviaz 4mg to 8mg
Drug: Toviaz (Fesoterodine)
4mg to 8mg by mouth once daily
Also known as: Toviaz
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: screening (Month 0), 2-months, 3-months, 7-months
| Milestone | Toviaz (Fesoterodine) |
|---|---|
| Started | 17 |
| Completed | 11 |
| Not completed | 6 |
| Withdrew: Adverse event | 6 |
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.
| units on a scale | IPSS Obstructive |
|---|---|
| Time Screening Month-0 | 9.1 ± 3.9 |
| Time Month-2 | 7.5 ± 5.1 |
| Time Month-3 | 8.4 ± 4.1 |
| Time Month-7 | 7.9 ± 4.3 |
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
| units on a scale | IPSS Irritative |
|---|---|
| Time Screening Month-0 | 6.6 ± 2.1 |
| Time Month-2 | 5.6 ± 2.6 |
| Time Month-3 | 5.1 ± 2.2 |
| Time Month-7 | 4.4 ± 2.4 |
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.
| units on a scale | IPSS Nocturia |
|---|---|
| Time Screening Month-0 | 3.2 ± 1.6 |
| Time Month-2 | 2.8 ± 1.6 |
| Time Month-3 | 2.6 ± 1.3 |
| Time Month-7 | 2.6 ± 1.3 |
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.
| units on a scale | IPSS QoL |
|---|---|
| Time Screening Month-0 | 4.2 ± 1.1 |
| Time Month-2 | 3.8 ± 1.3 |
| Time Month-3 | 3.5 ± 1.5 |
| Time Month-7 | 3.5 ± 1.5 |
Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary
| mL/s | Qmax |
|---|---|
| Time Screening Month-0 | 15.3 ± 18.0 |
| Time Month-2 | 10.2 ± 3.5 |
| Time Month-3 | 10.6 ± 3.9 |
| Time Month-7 | 10.5 ± 4.2 |
Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time
| mL/s | QAvg |
|---|---|
| Time Screening Month-0 | NA ± NA |
| Time Month-2 | 5.1 ± 2.0 |
| Time Month-3 | 6.1 ± 2.6 |
| Time Month-7 | 6.2 ± 3.0 |
Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition.
| mL | Post-void Residual Volume (PVR) |
|---|---|
| Time Screening Month-0 | 42.9 ± 43.2 |
| Time Month-2 | 33.1 ± 39.4 |
| Time Month-3 | 48.2 ± 64.8 |
| Time Month-7 | 55.2 ± 56.1 |
Collected over Adverse events were collected over the study period which was 7-months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Toviaz (Fesoterodine) | 0/17 (0%) | 0/17 (0%) | 6/17 (35.3%) |
| Event | Toviaz (Fesoterodine) |
|---|---|
| Constipation/Dry MouthGastrointestinal disorders | 3/17 |
| Urinary LeakageRenal and urinary disorders | 2/17 |
| Nausea/VomitingGastrointestinal disorders | 1/17 |
| Age, Continuous(years) | Toviaz (Fesoterodine) |
|---|---|
| Mean | 72.1 (53 to 91) |
| Sex: Female, Male(Participants) | Toviaz (Fesoterodine) |
|---|---|
| Female | 0 |
| Male | 17 |
| Region of Enrollment(participants) | Toviaz (Fesoterodine) |
|---|---|
| United States | 17 |
| BMI(kg/m^2) | Toviaz (Fesoterodine) |
|---|---|
| Mean | 28.3 (19.1 to 35.9) |
| Voided Volume(mL) | Toviaz (Fesoterodine) |
|---|---|
| Mean | 86 (20 to 292) |
| Laser(participants) | Toviaz (Fesoterodine) |
|---|---|
| Number | 13 |
| TURP(participants) | Toviaz (Fesoterodine) |
|---|---|
| Number | 4 |
Plan to share: No — No plan to share data
No publications or documents are linked to this record.
The record gives a start of Jan 2010, a primary completion of Jan 2013 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2018, 5 years 3 months after primary completion.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fesoterodine
Urinary Bladder Neck Obstruction →
Weill Medical College of Cornell University →