Bladder Outlet Obstruction Clinical Trial
— ToviazOfficial 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
Verified date | March 2018 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years to 99 Years |
Eligibility |
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 1. Male =40 years of age 2. Clinical signs and symptoms of frequency and urgency, enlarged prostate and urodynamic study consistent with overactive bladder. 3. IPSS >12, with IPSS QoL > 3 at screening visit. 4. Ability and willingness to correctly complete the micturition diary and all the trial related questionnaires comply with scheduled visits and comply with trial procedures. 5. 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. 6. Procedure to treat BOO by TURP or PVP greater than or equal to 1 month ago. Exclusion Criteria 1. 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. 2. Evidence of Urinary Tract Infection according to local standard of care. 3. 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. 4. Use of any electrostimulation within the 30 days before randomization, or the expectation to initiate such therapy during the study. 5. 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. 6. 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. 7. Use of any other investigational drug in the 2 months preceding visit 1. 8. History of postural hypotension or syncope in the judgement of the investigator based on local standards of care. 9. Alcohol and/or any other drug abuse in the opinion of the investigator. 10. Medications such as erythromycin, Biaxin (Clarithromycin), Sporanox (itraconazole), Nizoral (ketoconazole), Neoral and Sandimmune (cyclosporine), Velban (vinblastine) and miconazole. 11. Non-medication treatments such as bio-feedback or other bladder training exercises. |
Country | Name | City | State |
---|---|---|---|
United States | New York Hospital, Cornell University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | screening (Month 0), 2-months, 3-months, 7-months | |
Primary | 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 | screening (Month 0), 2-months, 3-months, 7-months | |
Primary | 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. | screening (Month 0), 2-months, 3-months, 7-months | |
Primary | 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. | screening (Month 0), 2-months, 3-months, 7-months | |
Primary | Maximum Flow Rate (Qmax) | Urodynamics was used to meause maximum flow rate (Qmax) which is the maximum recorded flow rate of urinary | screening (Month 0), 2-months, 3-months, 7-months | |
Primary | Average Flow Rate (Qavg) | Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time | screening (Month 0), 2-months, 3-months, 7-months | |
Primary | Postvoid Residual Volume (PVR) | Postvoid residual volume (PVR) is the volume of fluid remaining in the bladder immediately after the completion of micturition. | screening (Month 0), 2-months, 3-months, 7-months |
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