Topical Anesthetic Use In Pessary Management

• Sponsor: Loyola University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02380742
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 7.1
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: lidocaine-prilocaine cream; Drug: Placebo cream	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Topical Anesthetic Use In Pessary Management: A Randomized Double Blinded Placebo Controlled Trial
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lidocaine-prilocaine 4 mL of lidocaine-prilocaine cream	Drug: 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; Other Names: 5% EMLA cream
Placebo Comparator: Placebo 4 mL of placebo cream	Drug: 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. 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)

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Medical Center	Maywood	Illinois	United States	60153

Sponsors and Collaborators

• Loyola University

Investigators

• Principal Investigator: Cynthia Brincat, MD, Loyola University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Donnelly MJ, Powell-Morgan S, Olsen AL, Nygaard IE. Vaginal pessaries for the management of stress and mixed urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Sep-Oct;15(5):302-7. Epub 2004 Aug 5.
• Keskin AE, Onaran Y, Duvan IC, Simavli S, Kafali H. Topical anesthetic (lidocaine-prilocaine) cream application before speculum examination in postmenopausal women. J Minim Invasive Gynecol. 2012 May-Jun;19(3):350-5. doi: 10.1016/j.jmig.2012.01.005. Epub 2012 Mar 13.
• Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011 Jul;114(1):56-9. doi: 10.1016/j.ijgo.2011.02.006. Epub 2011 May 14.
• Melville JL, Katon W, Delaney K, Newton K. Urinary incontinence in US women: a population-based study. Arch Intern Med. 2005 Mar 14;165(5):537-42.
• Nguyen JN, Jones CR. Pessary treatment of pelvic relaxation: factors affecting successful fitting and continued use. J Wound Ostomy Continence Nurs. 2005 Jul-Aug;32(4):255-61; quiz 262-3.
• Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97.
• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6.
• Wahlgren CF, Lillieborg S. Split-skin grafting with lidocaine-prilocaine cream: A meta-analysis of efficacy and safety in geriatric versus nongeriatric patients. Plast Reconstr Surg. 2001 Mar;107(3):750-6.
• Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv. 2002 Mar;57(3):171-8. Review.

• Responsible Party: Cynthia Brincat, Assistant Professor, Loyola University
• ClinicalTrials.gov Identifier: NCT02380742
• Other Study ID Numbers: 206945
• First Posted: Mar 5, 2015
• Last Update Posted: Feb 23, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Cynthia Brincat, Assistant Professor, Loyola University: Pessary; Pain; EMLA; lidocaine; prilocaine
• Additional relevant MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination

Study Results

Participant Flow

Arm/Group Title	Lidocaine-prilocaine	Placebo
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	28	26
COMPLETED	27	26
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Lidocaine-prilocaine	Placebo	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	27	26	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.64 (10.43)	79.95 (8.01)	77.76 (9.49)
Gender (Count of Participants)
Female	27 100%	26 100%	53 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 11.1%	2 7.7%	5 9.4%
Not Hispanic or Latino	23 85.2%	24 92.3%	47 88.7%
Unknown or Not Reported	1 3.7%	0 0%	1 1.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 3.8%	1 1.9%
White	25 92.6%	22 84.6%	47 88.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 7.4%	3 11.5%	5 9.4%
BMI, Continuous (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.11 (6.06)	29.47 (6.59)	28.78 (6.30)
Median gravidity (IQR) (number of pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [number of pregnancies]	3	3	3
Median parity (range) (number of viable pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [number of viable pregnancies]	3	3	3
Median pessary months (IQR) (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	18	14	15
Median pessary size (IQR) (mm) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mm]	70	70	70
Reason for pessary (participants) [Number]
Prolapse	14 51.9%	15 57.7%	29 54.7%
Incontinence	7 25.9%	1 3.8%	8 15.1%
Prolapse & Incontinence	6 22.2%	10 38.5%	16 30.2%
Type of pessary (participants) [Number]
Gelhorn	0 0%	5 19.2%	5 9.4%
Ring	3 11.1%	1 3.8%	4 7.5%
Ring with support	13 48.1%	10 38.5%	23 43.4%
Incontinence ring	2 7.4%	1 3.8%	3 5.7%
Incontinence dish	4 14.8%	4 15.4%	8 15.1%
Incontinence dish with support	5 18.5%	5 19.2%	10 18.9%
Vaginal erosions (participants) [Number]
No	25 92.6%	23 88.5%	48 90.6%
Yes	2 7.4%	3 11.5%	5 9.4%
Weekly topical estrogen (participants) [Number]
No	20 74.1%	16 61.5%	36 67.9%
Yes	7 25.9%	10 38.5%	17 32.1%
Menopausal status (participants) [Number]
Premenopausal	0 0%	0 0%	0 0%
Postmenopausal	27 100%	26 100%	53 100%
Mean age at menopause (SD) (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.67 (5.92)	49.10 (6.85)	48.88 (6.33)
Prior hysterectomy (participants) [Number]
No	16 59.3%	19 73.1%	35 66%
Yes	11 40.7%	7 26.9%	18 34%
Sexually active (participants) [Number]
No	23 85.2%	26 100%	49 92.5%
Yes	4 14.8%	0 0%	4 7.5%
Pain with intercourse (participants) [Number]
No	12 44.4%	9 34.6%	21 39.6%
Yes	0 0%	0 0%	0 0%
Not applicable	15 55.6%	17 65.4%	32 60.4%
Tobacco use (participants) [Number]
No	26 96.3%	24 92.3%	50 94.3%
Yes	1 3.7%	2 7.7%	3 5.7%
Pessary satisfaction (participants) [Number]
Dissatisfied	0 0%	0 0%	0 0%
Somewhat dissatisfied	0 0%	1 3.8%	1 1.9%
Neutral	1 3.7%	0 0%	1 1.9%
Somewhat satisfied	4 14.8%	6 23.1%	10 18.9%
Very satisfied	22 81.5%	19 73.1%	41 77.4%
Baseline VAS scores (units on a scale) [Mean (Standard Deviation) ]
Mean paper form	0.29 (0.73)	0.23 (0.48)	0.26 (0.61)
Mean electronic form	0.51 (0.69)	0.52 (0.51)	0.52 (0.60)

Outcome Measures

1. Primary Outcome

Title	VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine-prilocaine	Placebo
Arm/Group Description	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	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
Measure Participants	27	26
Least Squares Mean (Standard Error) [Centimeters]	1.76 (0.57)	3.81 (0.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lidocaine-prilocaine, Placebo
	Comments	The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.02
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.87
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.47
	Estimation Comments

2. Secondary Outcome

Title	VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine-prilocaine	Placebo
Arm/Group Description	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	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
Measure Participants	27	26
Least Squares Mean (Standard Error) [Centimeters]	1.81 (0.59)	3.76 (0.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lidocaine-prilocaine, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.03
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.96
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.87
	Estimation Comments

3. Secondary Outcome

Title	VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lidocaine-prilocaine	Placebo
Arm/Group Description	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	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
Measure Participants	27	26
Least Squares Mean (Standard Error) [Centimeters]	1.88 (0.58)	3.69 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lidocaine-prilocaine, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.03
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.811
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.83
	Estimation Comments

4. Secondary Outcome

Title	VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lidocaine-prilocaine	Placebo
Arm/Group Description	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	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
Measure Participants	27	25
Least Squares Mean (Standard Error) [Centimeters]	0.61 (0.43)	1.68 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lidocaine-prilocaine, Placebo
	Comments	The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.09
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.07
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.63
	Estimation Comments

Adverse Events

Time Frame	Reported adverse events includes events from initial enrollment to study completion.
Arm/Group Title	Lidocaine-prilocaine		Placebo
Arm/Group Description	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		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
All Cause Mortality
	Lidocaine-prilocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lidocaine-prilocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Lidocaine-prilocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)

Limitations/Caveats

There are no limitations or caveats to report.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.