Trial Outcomes & Findings for Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1 (NCT NCT01661621)

NCT ID: NCT01661621

Last Updated: 2014-06-25

Results Overview

Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month. The global response assessment on a 6-point scale ranging from 1 "No problems at all" to 6 "Many severe problems". Changes of the global response assessment (GRA) improved or reduction by 1 points. Change = Baseline minus Month 1 value Safety: Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 395 participants
• Primary outcome timeframe: 1 month after initial treatment
• Results posted on: 2014-06-25

Participant Flow

Participant milestones

Measure	Group 1 Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
Overall Study STARTED	116	279
Overall Study COMPLETED	116	279
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1

Baseline characteristics by cohort

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2	Total n=395 Participants Total of all reporting groups
Age, Continuous	68.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	65.6 years STANDARD_DEVIATION 10.5 • n=7 Participants	66.4 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	279 Participants n=7 Participants	395 Participants n=5 Participants
Region of Enrollment Taiwan	116 participants n=5 Participants	279 participants n=7 Participants	395 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after initial treatment

Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.

The global response assessment on a 6-point scale ranging from 1 "No problems at all" to 6 "Many severe problems".

Changes of the global response assessment (GRA) improved or reduction by 1 points.

Change = Baseline minus Month 1 value

Safety:

Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The Global Response Assessment (GRA) After the Treatment Day GRA≥1	89 participants	218 participants
The Global Response Assessment (GRA) After the Treatment Day GRA<1	27 participants	61 participants

SECONDARY outcome

Timeframe: Baseline and 1 month

Efficacy:

Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.

The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always".

Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35

Safety:

Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day Baseline	14.8 units on a scale Standard Deviation 5.40	18.0 units on a scale Standard Deviation 6.47
The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day 1 month	11.2 units on a scale Standard Deviation 6.81	10.8 units on a scale Standard Deviation 6.36

SECONDARY outcome

Timeframe: Baseline and 1 month

Efficacy:

Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.

Safety:

Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The Maximum Flow Rate (Qmax) After the Treatment Day Baseline	13.1 mL/s Standard Deviation 8.10	11.4 mL/s Standard Deviation 5.95
The Maximum Flow Rate (Qmax) After the Treatment Day 1 month	13.6 mL/s Standard Deviation 7.90	13.6 mL/s Standard Deviation 6.63

SECONDARY outcome

Timeframe: Baseline and 1 month

Efficacy:

Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.

Safety:

Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The Voided Volume After the Treatment Day Baseline	212.5 mL Standard Deviation 168.8	244.0 mL Standard Deviation 148.3
The Voided Volume After the Treatment Day 1 month	231.6 mL Standard Deviation 163.6	268.3 mL Standard Deviation 150.7

SECONDARY outcome

Timeframe: Baseline and 1 month

Efficacy:

Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.

Safety:

Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The Postvoid Residual Volume (PVR) After the Treatment Day Baseline	50.1 mL Standard Deviation 62.6	53.9 mL Standard Deviation 58.7
The Postvoid Residual Volume (PVR) After the Treatment Day 1 month	60.4 mL Standard Deviation 60.4	42.9 mL Standard Deviation 49.3

SECONDARY outcome

Timeframe: Baseline and 1 month

Efficacy:

Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.

The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.

The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).

Safety:

Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day Baseline	5.31 units on a scale Standard Deviation 3.51	12.3 units on a scale Standard Deviation 4.37
The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day 1 month	4.84 units on a scale Standard Deviation 4.75	6.49 units on a scale Standard Deviation 4.97

SECONDARY outcome

Timeframe: Baseline and 1 month

Efficacy:

Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.

The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.

The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).

Safety:

Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day Baseline	9.51 units on a scale Standard Deviation 3.05	5.70 units on a scale Standard Deviation 3.09
The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day 1 month	6.40 units on a scale Standard Deviation 3.47	4.31 units on a scale Standard Deviation 2.80

SECONDARY outcome

Timeframe: Baseline and 1 month

Efficacy:

Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.

The IPSS quality of life question score on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible".

IPSS-QoL ranges 0 to 6 (Delighted to Terrible)

Safety:

Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness

Outcome measures

Measure	Group 1 n=116 Participants Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 Participants α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day Baseline	3.91 units on a scale Standard Deviation 1.01	3.88 units on a scale Standard Deviation 0.82
The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day 1 month	2.82 units on a scale Standard Deviation 1.18	2.82 units on a scale Standard Deviation 0.96

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 n=116 participants at risk Antimuscarinics (Detrusitol 4 mg QD) Detrusitol 4 mg QD: Group 1	Group 2 n=279 participants at risk α-blockers (Doxazosin 4 mg QD) Doxazosin 4 mg QD: Group 2
General disorders Dizziness	10.3% 12/116	0.00% 0/279
General disorders General weakness	2.6% 3/116	0.00% 0/279
General disorders Palpitation	2.6% 3/116	0.00% 0/279
General disorders Dry mouth	0.00% 0/116	4.7% 13/279
General disorders Blurred vision	0.00% 0/116	3.6% 10/279
General disorders Dry eye	0.00% 0/116	2.5% 7/279
General disorders Constipation	0.00% 0/116	1.1% 3/279

Additional Information

Dr. Hann-Chorng Kuo

Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

Phone: 886-3-8561825

Email: hck@tzuchi.com.tw

Results disclosure agreements

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