Trial Outcomes & Findings for Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS (NCT NCT01589263)

NCT ID: NCT01589263

Last Updated: 2021-10-05

Results Overview

AUA Symptom Score on a scale of 0 to 35, 35 is the worse outcome and 0 is the best outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 63 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-10-05

Participant Flow

63 subjects were consented and Informed Consent was signed by all of the subjects. These subjects were selected from PI's medical clinic. PI and the CRC explained the study to these subjects but only 21 participants started the intervention.

Participant milestones

Measure	ARM 1: onaBoNT-A + Placebo onaBoNT-A 200 U prostate injection and placebo oral capsule daily onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin	ARM 2: Saline + Tamsulosin Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily. onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin
Overall Study STARTED	9	12
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	ARM 1: onaBoNT-A + Placebo n=9 Participants onaBoNT-A 200 U prostate injection and placebo oral capsule daily onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin	ARM 2: Saline + Tamsulosin n=12 Participants Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily. onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=9 Participants	12 Participants n=12 Participants	21 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants	0 Participants n=12 Participants	0 Participants n=21 Participants
Sex/Gender, Customized Male	9 participants n=9 Participants	12 participants n=12 Participants	21 participants n=21 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
PSA	1.35 ng/mL STANDARD_DEVIATION 1.35 • n=9 Participants	1.725 ng/mL STANDARD_DEVIATION 1.725 • n=12 Participants	1.5 ng/mL STANDARD_DEVIATION 1.5 • n=21 Participants
Prostate Volume	26.79 CC STANDARD_DEVIATION 26.79 • n=9 Participants	32.33 CC STANDARD_DEVIATION 32.33 • n=12 Participants	29.56 CC STANDARD_DEVIATION 29.56 • n=21 Participants
AUA Symptom Score	22.92 units on a scale STANDARD_DEVIATION 22.92 • n=9 Participants	22.78 units on a scale STANDARD_DEVIATION 22.78 • n=12 Participants	22.85 units on a scale STANDARD_DEVIATION 22.85 • n=21 Participants
BPH Impact Score	7.83 units on a scale STANDARD_DEVIATION 7.83 • n=9 Participants	6.11 units on a scale STANDARD_DEVIATION 6.11 • n=12 Participants	6.97 units on a scale STANDARD_DEVIATION 6.97 • n=21 Participants
Bladder Function Score	7.58 units on a scale STANDARD_DEVIATION 7.58 • n=9 Participants	7.44 units on a scale STANDARD_DEVIATION 7.44 • n=12 Participants	7.51 units on a scale STANDARD_DEVIATION 7.51 • n=21 Participants
Erectile Function Score	21.58 units on a scale STANDARD_DEVIATION 21.58 • n=9 Participants	29.56 units on a scale STANDARD_DEVIATION 29.56 • n=12 Participants	25.57 units on a scale STANDARD_DEVIATION 25.57 • n=21 Participants
Ejaculation Function Score	20.58 units on a scale STANDARD_DEVIATION 20.58 • n=9 Participants	17.44 units on a scale STANDARD_DEVIATION 17.44 • n=12 Participants	19.01 units on a scale STANDARD_DEVIATION 19.01 • n=21 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Volunteers were randomized on a 1:1 assignment by the MEDVAMC Research Pharmacy to either: ARM 1: BoNT-A 200 U prostate injection and placebo oral capsule daily or ARM 2: Placebo prostate injection (saline) and Tamsulosin 0.4 mg capsule daily.

AUA Symptom Score on a scale of 0 to 35, 35 is the worse outcome and 0 is the best outcome.

Outcome measures

Measure	ARM 1: onaBoNT-A + Placebo n=9 Participants onaBoNT-A 200 U prostate injection and placebo oral capsule daily onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin	ARM 2: Saline + Tamsulosin n=12 Participants Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily. onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin
American Urologic Association Symptom Score (AUASS)	18.66 score on a scale Standard Deviation 0.07	14.16 score on a scale Standard Deviation 0.05

Adverse Events

ARM 1: onaBoNT-A + Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

ARM 2: Saline + Tamsulosin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ARM 1: onaBoNT-A + Placebo n=9 participants at risk onaBoNT-A 200 U prostate injection and placebo oral capsule daily onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin	ARM 2: Saline + Tamsulosin n=12 participants at risk Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily. onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin
Gastrointestinal disorders Unrelated	11.1% 1/9 • Number of events 1 • 19.6 month period.	0.00% 0/12 • 19.6 month period.

Other adverse events

Measure	ARM 1: onaBoNT-A + Placebo n=9 participants at risk onaBoNT-A 200 U prostate injection and placebo oral capsule daily onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin	ARM 2: Saline + Tamsulosin n=12 participants at risk Placebo prostate injection (saline) and tamsulosin 0.4 mg capsule daily. onaBoNT-A + placebo: 200 U prostate injection once Arms: ARM 1: onaBoNT-A + placebo Tamsulosin + placebo: 0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin
Gastrointestinal disorders Unrelated	11.1% 1/9 • Number of events 1 • 19.6 month period.	0.00% 0/12 • 19.6 month period.

Additional Information

Christopher Smith

Baylor College of Medicine

Phone: 713-798-4001

Email: cps@bcm.edu

Results disclosure agreements

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