Trial Outcomes & Findings for Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia (NCT NCT00928564)

NCT ID: NCT00928564

Last Updated: 2021-02-10

Results Overview

10 point likert scale to report pain a score from zero for no pain to ten for the worst possible pain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: up to 8 weeks
• Results posted on: 2021-02-10

Participant Flow

Participant milestones

Measure	Pudendal Block 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site. Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.	Placebo 5ml of saline at each block site Placebo: 5ml of saline at each block site.
Overall Study STARTED	28	12
Overall Study COMPLETED	22	12
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Measure	Pudendal Block 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site. Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.	Placebo 5ml of saline at each block site Placebo: 5ml of saline at each block site.
Overall Study Lost to Follow-up	6	0

Baseline Characteristics

Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia

Baseline characteristics by cohort

Measure	Pudendal Block n=28 Participants 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site. Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.	Placebo n=12 Participants 5ml of saline at each block site Placebo: 5ml of saline at each block site.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=93 Participants	12 Participants n=4 Participants	40 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	46 years STANDARD_DEVIATION 3 • n=93 Participants	45 years STANDARD_DEVIATION 4 • n=4 Participants	46 years STANDARD_DEVIATION 3 • n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	12 Participants n=4 Participants	40 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	23 Participants n=93 Participants	10 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	28 participants n=93 Participants	12 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: up to 8 weeks

10 point likert scale to report pain a score from zero for no pain to ten for the worst possible pain

Outcome measures

Measure	Pudendal Block n=22 Participants 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site. Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.	Placebo n=12 Participants 5ml of saline at each block site Placebo: 5ml of saline at each block site.
Visual Analog Pain Score After 6 Weekly Injections	3.33 Visual Analog Pain Score Standard Deviation 1.87	2.99 Visual Analog Pain Score Standard Deviation 2.03

SECONDARY outcome

Timeframe: up to 6 months

The Pelvic Floor Distress Inventory (PFDI) has 20 items and 3 scales, the response scale is from 0-4. Summary scores range from 0-300 with higher scores indicating more distress.

Outcome measures

Measure	Pudendal Block n=22 Participants 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site. Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.	Placebo n=12 Participants 5ml of saline at each block site Placebo: 5ml of saline at each block site.
Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires	47.2 score on a scale Standard Deviation 30.8	38.2 score on a scale Standard Deviation 29

Adverse Events

Pudendal Block

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pudendal Block n=22 participants at risk 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site. Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.	Placebo n=12 participants at risk 5ml of saline at each block site Placebo: 5ml of saline at each block site.
Surgical and medical procedures vaginal bleeding	9.1% 2/22 • 6 weeks post treatment.	33.3% 4/12 • 6 weeks post treatment.
Surgical and medical procedures Toe numbness	9.1% 2/22 • 6 weeks post treatment.	0.00% 0/12 • 6 weeks post treatment.

Additional Information

Dr. Felicia Lane

UC Irvine

Phone: 17144566155

Email: kbacca@uci.edu

Results disclosure agreements

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