Pain
Conditions
Keywords
Pessary, Pain, EMLA, lidocaine, prilocaine
Brief summary
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.
Detailed description
Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream. Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.
Interventions
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
DRUGPlacebo 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
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI) * Read and speak the English language
Exclusion criteria
* Non-English speaking * Allergy or contraindication to topical anesthetic * Participation/randomization in the study at a previous visit * Currently pregnant or lactating or planning a pregnancy within the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain | Removal of Pessary | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training | Removal of Pessary | Self-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) |
| VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age | Removal of Pessary | Self-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) |
| VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain | Insertion of Pessary | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 27 |
| 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 | 26 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Lidocaine-prilocaine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 75.64 years STANDARD_DEVIATION 10.43 | 77.76 years STANDARD_DEVIATION 9.49 | 79.95 years STANDARD_DEVIATION 8.01 |
| Baseline VAS scores Mean electronic form | 0.51 units on a scale STANDARD_DEVIATION 0.69 | 0.52 units on a scale STANDARD_DEVIATION 0.6 | 0.52 units on a scale STANDARD_DEVIATION 0.51 |
| Baseline VAS scores Mean paper form | 0.29 units on a scale STANDARD_DEVIATION 0.73 | 0.26 units on a scale STANDARD_DEVIATION 0.61 | 0.23 units on a scale STANDARD_DEVIATION 0.48 |
| BMI, Continuous | 28.11 kg/m^2 STANDARD_DEVIATION 6.06 | 28.78 kg/m^2 STANDARD_DEVIATION 6.3 | 29.47 kg/m^2 STANDARD_DEVIATION 6.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 47 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Gender Female | 27 Participants | 53 Participants | 26 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Mean age at menopause (SD) | 48.67 years STANDARD_DEVIATION 5.92 | 48.88 years STANDARD_DEVIATION 6.33 | 49.10 years STANDARD_DEVIATION 6.85 |
| Median gravidity (IQR) | 3 number of pregnancies | 3 number of pregnancies | 3 number of pregnancies |
| Median parity (range) | 3 number of viable pregnancies | 3 number of viable pregnancies | 3 number of viable pregnancies |
| Median pessary months (IQR) | 18 months | 15 months | 14 months |
| Median pessary size (IQR) | 70 mm | 70 mm | 70 mm |
| Menopausal status Postmenopausal | 27 participants | 53 participants | 26 participants |
| Menopausal status Premenopausal | 0 participants | 0 participants | 0 participants |
| Pain with intercourse No | 12 participants | 21 participants | 9 participants |
| Pain with intercourse Not applicable | 15 participants | 32 participants | 17 participants |
| Pain with intercourse Yes | 0 participants | 0 participants | 0 participants |
| Pessary satisfaction Dissatisfied | 0 participants | 0 participants | 0 participants |
| Pessary satisfaction Neutral | 1 participants | 1 participants | 0 participants |
| Pessary satisfaction Somewhat dissatisfied | 0 participants | 1 participants | 1 participants |
| Pessary satisfaction Somewhat satisfied | 4 participants | 10 participants | 6 participants |
| Pessary satisfaction Very satisfied | 22 participants | 41 participants | 19 participants |
| Prior hysterectomy No | 16 participants | 35 participants | 19 participants |
| Prior hysterectomy Yes | 11 participants | 18 participants | 7 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 25 Participants | 47 Participants | 22 Participants |
| Reason for pessary Incontinence | 7 participants | 8 participants | 1 participants |
| Reason for pessary Prolapse | 14 participants | 29 participants | 15 participants |
| Reason for pessary Prolapse & Incontinence | 6 participants | 16 participants | 10 participants |
| Sexually active No | 23 participants | 49 participants | 26 participants |
| Sexually active Yes | 4 participants | 4 participants | 0 participants |
| Tobacco use No | 26 participants | 50 participants | 24 participants |
| Tobacco use Yes | 1 participants | 3 participants | 2 participants |
| Type of pessary Gelhorn | 0 participants | 5 participants | 5 participants |
| Type of pessary Incontinence dish | 4 participants | 8 participants | 4 participants |
| Type of pessary Incontinence dish with support | 5 participants | 10 participants | 5 participants |
| Type of pessary Incontinence ring | 2 participants | 3 participants | 1 participants |
| Type of pessary Ring | 3 participants | 4 participants | 1 participants |
| Type of pessary Ring with support | 13 participants | 23 participants | 10 participants |
| Vaginal erosions No | 25 participants | 48 participants | 23 participants |
| Vaginal erosions Yes | 2 participants | 5 participants | 3 participants |
| Weekly topical estrogen No | 20 participants | 36 participants | 16 participants |
| Weekly topical estrogen Yes | 7 participants | 17 participants | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
Primary
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
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)
Time frame: Removal of Pessary
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine-prilocaine | VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain | 1.76 Centimeters | Standard Error 0.57 |
| Placebo | VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain | 3.81 Centimeters | Standard Error 0.58 |
Comparison: The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.p-value: 0.02ANCOVA
Secondary
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
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)
Time frame: Insertion of Pessary
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine-prilocaine | VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain | 0.61 Centimeters | Standard Error 0.43 |
| Placebo | VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain | 1.68 Centimeters | Standard Error 0.44 |
Comparison: The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.p-value: 0.09ANCOVA
Secondary
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
Self-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)
Time frame: Removal of Pessary
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine-prilocaine | VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age | 1.88 Centimeters | Standard Error 0.58 |
| Placebo | VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age | 3.69 Centimeters | Standard Error 0.59 |
Comparison: The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain and patient age.p-value: 0.03ANCOVA
Secondary
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
Self-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)
Time frame: Removal of Pessary
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine-prilocaine | VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training | 1.81 Centimeters | Standard Error 0.59 |
| Placebo | VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training | 3.76 Centimeters | Standard Error 0.6 |
Comparison: The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for investigator training and pessary type.p-value: 0.03ANCOVA