Trial Outcomes & Findings for Minimizing Pain During Office Intradetrussor Botox Injection (NCT NCT04270526)

NCT ID: NCT04270526

Last Updated: 2025-03-06

Results Overview

Pain on visual analog scale from 0-100 with higher scores worse

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 85 participants
• Primary outcome timeframe: Immediately after the procedure
• Results posted on: 2025-03-06

Participant Flow

Participant milestones

Measure	Active Treatment 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate Bicarbonate protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate	Placebo Treatment 50 mL 1% lidocaine + 50ml of 0.9% normal saline Standard protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline
Overall Study STARTED	38	38
Overall Study COMPLETED	36	37
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minimizing Pain During Office Intradetrussor Botox Injection

Baseline characteristics by cohort

Measure	Active Treatment n=37 Participants 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate Bicarbonate protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate	Placebo Treatment n=36 Participants 50 mL 1% lidocaine + 50ml of 0.9% normal saline Standard protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline	Total n=73 Participants Total of all reporting groups
Age, Continuous	74 years n=5 Participants	71 years n=7 Participants	72 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after the procedure

Pain on visual analog scale from 0-100 with higher scores worse

Outcome measures

Measure	Active Treatment n=37 Participants 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate Bicarbonate protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate	Placebo Treatment n=36 Participants 50 mL 1% lidocaine + 50ml of 0.9% normal saline Standard protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline
Pain: VAS	25 units on a scale, 0-100 Interval 15.0 to 55.0	16 units on a scale, 0-100 Interval 9.0 to 40.0

SECONDARY outcome

Timeframe: Immediately after the procedure

Likert scale questions assessing overall satisfaction with the procedure with responses from very 1 (dissatisfied) to 5 (very satisfied) with higher scores representing more satisfaction. We reported the percentage of participants who were satisfied we defined as a response of 4 or 5.

Outcome measures

Measure	Active Treatment n=37 Participants 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate Bicarbonate protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate	Placebo Treatment n=36 Participants 50 mL 1% lidocaine + 50ml of 0.9% normal saline Standard protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline
Satisfaction: Likert Scale	68 percentage of participants with 4 or 5	39 percentage of participants with 4 or 5

SECONDARY outcome

Timeframe: Immediately after the procedure

Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely (1) to very unlikely (5) with five items total. We defined willingness to undergo repeat procedure as a score of 1 or 2 on the Likert scale and outcome measured was the percentage of patients who responded with a 1 or 2.

Outcome measures

Measure	Active Treatment n=37 Participants 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate Bicarbonate protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate	Placebo Treatment n=36 Participants 50 mL 1% lidocaine + 50ml of 0.9% normal saline Standard protocol: Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline
Willingness to Undergo Repeat Procedure	72 percentage of participants	65 percentage of participants

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Winkelman

Mount Auburn Hospital

Phone: 617-354-5452

Email: william.winkelman@mah.harvard.edu

Results disclosure agreements

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