Trial Outcomes & Findings for Topical Anesthetic Use In Pessary Management (NCT NCT02380742)
NCT ID: NCT02380742
Last Updated: 2017-02-23
Results Overview
Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Removal of Pessary
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
Lidocaine-prilocaine
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lidocaine-prilocaine
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Topical Anesthetic Use In Pessary Management
Baseline characteristics by cohort
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.64 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
79.95 years
STANDARD_DEVIATION 8.01 • n=7 Participants
|
77.76 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
|
Gender
Female
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 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
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
BMI, Continuous
|
28.11 kg/m^2
STANDARD_DEVIATION 6.06 • n=5 Participants
|
29.47 kg/m^2
STANDARD_DEVIATION 6.59 • n=7 Participants
|
28.78 kg/m^2
STANDARD_DEVIATION 6.30 • n=5 Participants
|
|
Median gravidity (IQR)
|
3 number of pregnancies
n=5 Participants
|
3 number of pregnancies
n=7 Participants
|
3 number of pregnancies
n=5 Participants
|
|
Median parity (range)
|
3 number of viable pregnancies
n=5 Participants
|
3 number of viable pregnancies
n=7 Participants
|
3 number of viable pregnancies
n=5 Participants
|
|
Median pessary months (IQR)
|
18 months
n=5 Participants
|
14 months
n=7 Participants
|
15 months
n=5 Participants
|
|
Median pessary size (IQR)
|
70 mm
n=5 Participants
|
70 mm
n=7 Participants
|
70 mm
n=5 Participants
|
|
Reason for pessary
Prolapse
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Reason for pessary
Incontinence
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Reason for pessary
Prolapse & Incontinence
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Type of pessary
Gelhorn
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Type of pessary
Ring
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Type of pessary
Ring with support
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Type of pessary
Incontinence ring
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Type of pessary
Incontinence dish
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Type of pessary
Incontinence dish with support
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Vaginal erosions
No
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Vaginal erosions
Yes
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Weekly topical estrogen
No
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Weekly topical estrogen
Yes
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Menopausal status
Premenopausal
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Menopausal status
Postmenopausal
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Mean age at menopause (SD)
|
48.67 years
STANDARD_DEVIATION 5.92 • n=5 Participants
|
49.10 years
STANDARD_DEVIATION 6.85 • n=7 Participants
|
48.88 years
STANDARD_DEVIATION 6.33 • n=5 Participants
|
|
Prior hysterectomy
No
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Prior hysterectomy
Yes
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Sexually active
No
|
23 participants
n=5 Participants
|
26 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Sexually active
Yes
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Pain with intercourse
No
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Pain with intercourse
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Pain with intercourse
Not applicable
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Tobacco use
No
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Tobacco use
Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Pessary satisfaction
Dissatisfied
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Pessary satisfaction
Somewhat dissatisfied
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Pessary satisfaction
Neutral
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Pessary satisfaction
Somewhat satisfied
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Pessary satisfaction
Very satisfied
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Baseline VAS scores
Mean paper form
|
0.29 units on a scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
0.23 units on a scale
STANDARD_DEVIATION 0.48 • n=7 Participants
|
0.26 units on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
|
Baseline VAS scores
Mean electronic form
|
0.51 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 0.51 • n=7 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
PRIMARY outcome
Timeframe: Removal of PessarySelf-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
|
1.76 Centimeters
Standard Error 0.57
|
3.81 Centimeters
Standard Error 0.58
|
SECONDARY outcome
Timeframe: Removal of PessarySelf-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
|
1.81 Centimeters
Standard Error 0.59
|
3.76 Centimeters
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Removal of PessarySelf-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=26 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
|
1.88 Centimeters
Standard Error 0.58
|
3.69 Centimeters
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Insertion of PessaryPopulation: After baseline and removal study activities were recorded, one of the patients in the placebo group was withdrawn by the investigator due to vaginal erosion.
Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)
Outcome measures
| Measure |
Lidocaine-prilocaine
n=27 Participants
4 mL of lidocaine-prilocaine cream
lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
Placebo
n=25 Participants
4 mL of placebo cream
Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
|
|---|---|---|
|
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
|
0.61 Centimeters
Standard Error 0.43
|
1.68 Centimeters
Standard Error 0.44
|
Adverse Events
Lidocaine-prilocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place