An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00605319

Acronym

Toviaz

Enrollment

Registered

2008-01-31

Start date

2010-01-31

Completion date

2013-01-31

Last updated

2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Outlet Obstruction

Keywords

BPH, BOO

Brief 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.

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.

Interventions

DRUGToviaz (Fesoterodine)

4mg to 8mg by mouth once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 99 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
IPSS Obstructive	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	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	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)	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)	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)	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)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Toviaz (Fesoterodine) Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily	17
Total	17

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	6

Baseline characteristics

Characteristic	Toviaz (Fesoterodine)
Age, Continuous	72.1 years
BMI	28.3 kg/m^2
Laser	13 participants
Region of Enrollment United States	17 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	17 Participants
TURP	4 participants
Voided Volume	86 mL

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 17
other Total, other adverse events	6 / 17
serious Total, serious adverse events	0 / 17

Outcome results

Primary

Average Flow Rate (Qavg)

Average (mean) flow rate (Qavg) is the the volume of urine voided divided by the continuous flow time