Trial Outcomes & Findings for An Open Label Study to Measure Efficacy of Fesoterodine (Toviaz) Post Surgery for Benign Prostatic Hyperplasia (NCT NCT00605319)

NCT ID: NCT00605319

Last Updated: 2018-04-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: screening (Month 0), 2-months, 3-months, 7-months
• Results posted on: 2018-04-10

Participant Flow

Participant milestones

Measure	Toviaz (Fesoterodine) Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Overall Study STARTED	17
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Toviaz (Fesoterodine) Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Overall Study Adverse Event	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Toviaz (Fesoterodine) n=17 Participants Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Age, Continuous	72.1 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
BMI	28.3 kg/m^2 n=5 Participants
Voided Volume	86 mL n=5 Participants
Laser	13 participants n=5 Participants
TURP	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	IPSS Obstructive n=17 Participants Obstructive description Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
IPSS Obstructive Time Screening Month-0	9.1 units on a scale Standard Deviation 3.9
IPSS Obstructive Time Month-2	7.5 units on a scale Standard Deviation 5.1
IPSS Obstructive Time Month-3	8.4 units on a scale Standard Deviation 4.1
IPSS Obstructive Time Month-7	7.9 units on a scale Standard Deviation 4.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	IPSS Obstructive n=17 Participants Obstructive description Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
IPSS Irritative Time Screening Month-0	6.6 units on a scale Standard Deviation 2.1
IPSS Irritative Time Month-2	5.6 units on a scale Standard Deviation 2.6
IPSS Irritative Time Month-3	5.1 units on a scale Standard Deviation 2.2
IPSS Irritative Time Month-7	4.4 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	IPSS Obstructive n=17 Participants Obstructive description Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
IPSS Nocturia Time Screening Month-0	3.2 units on a scale Standard Deviation 1.6
IPSS Nocturia Time Month-2	2.8 units on a scale Standard Deviation 1.6
IPSS Nocturia Time Month-3	2.6 units on a scale Standard Deviation 1.3
IPSS Nocturia Time Month-7	2.6 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	IPSS Obstructive n=17 Participants Obstructive description Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Time Screening Month-0	4.2 units on a scale Standard Deviation 1.1
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Time Month-2	3.8 units on a scale Standard Deviation 1.3
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Time Month-3	3.5 units on a scale Standard Deviation 1.5
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Time Month-7	3.5 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	IPSS Obstructive n=17 Participants Obstructive description Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Maximum Flow Rate (Qmax) Time Month-2	10.2 mL/s Standard Deviation 3.5
Maximum Flow Rate (Qmax) Time Screening Month-0	15.3 mL/s Standard Deviation 18.0
Maximum Flow Rate (Qmax) Time Month-3	10.6 mL/s Standard Deviation 3.9
Maximum Flow Rate (Qmax) Time Month-7	10.5 mL/s Standard Deviation 4.2

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	IPSS Obstructive n=17 Participants Obstructive description Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Average Flow Rate (Qavg) Time Screening Month-0	NA mL/s Standard Deviation NA At the time that Qavg was collected, the Qavg data was skewed and was seen to be irrelevant and thus not reported for the screening appointment.
Average Flow Rate (Qavg) Time Month-2	5.1 mL/s Standard Deviation 2.0
Average Flow Rate (Qavg) Time Month-3	6.1 mL/s Standard Deviation 2.6
Average Flow Rate (Qavg) Time Month-7	6.2 mL/s Standard Deviation 3.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	IPSS Obstructive n=17 Participants Obstructive description Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Postvoid Residual Volume (PVR) Time Screening Month-0	42.9 mL Standard Deviation 43.2
Postvoid Residual Volume (PVR) Time Month-2	33.1 mL Standard Deviation 39.4
Postvoid Residual Volume (PVR) Time Month-3	48.2 mL Standard Deviation 64.8
Postvoid Residual Volume (PVR) Time Month-7	55.2 mL Standard Deviation 56.1

Adverse Events

Toviaz (Fesoterodine)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Toviaz (Fesoterodine) n=17 participants at risk Toviaz 4mg to 8mg Toviaz (Fesoterodine): 4mg to 8mg by mouth once daily
Gastrointestinal disorders Constipation/Dry Mouth	17.6% 3/17 • Adverse events were collected over the study period which was 7-months.
Gastrointestinal disorders Nausea/Vomiting	5.9% 1/17 • Adverse events were collected over the study period which was 7-months.
Renal and urinary disorders Urinary Leakage	11.8% 2/17 • Adverse events were collected over the study period which was 7-months.

Additional Information

Dr. Alexis Te

Weill Cornell Medical College

Phone: 646-962-4811

Email: aet2005@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place