Lidocaine for Pessary Check Pain Reduction
Primary Purpose
Pelvic Organ Prolapse, Stress Urinary Incontinence
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine Hcl 2% Jelly
Placebo Jelly
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring Pessary, Lidocaine, Pain Reduction, Pessary Check, Pessary Removal, Pessary Reinsertion, Lubricating Jelly
Eligibility Criteria
Inclusion Criteria:
- Women aged 18 years or older
- Presenting for routine pessary management for prolapse, stress urinary incontinence, or both with a pessary in place
- able to provide written informed consent
- able to complete the visual analog scale
Exclusion Criteria:
- Women less than 18 years of age.
- Patients who speak neither English nor Spanish
- Pregnancy
- Medical contraindication to lidocaine
- Patients who remove and reinsert their pessary at home
Sites / Locations
- USF Health Outpatient Urogynecology ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Experimental
Arm Description
Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.
Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.
Outcomes
Primary Outcome Measures
Change in patient's pain using the visual analog scale (VAS) after pessary removal
Self-reported pain level 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
Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion
Self-reported pain level at time of pessary reinsertion controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Genital Hiatus with Valsalva
Genital hiatus measurement in centimeters prior to removal of the pessary
Full Information
NCT ID
NCT05493735
First Posted
July 15, 2022
Last Updated
March 16, 2023
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT05493735
Brief Title
Lidocaine for Pessary Check Pain Reduction
Official Title
Lidocaine for Pessary Removal and Reinsertion Pain Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.
Detailed Description
The purpose of the study is to investigate the effects of lidocaine jelly on patient pain at the time of office pessary removal and reinsertion. All patients presenting to the University of South Florida Urogynecology clinic for a pessary maintenance appointment or "pessary check" will be screened as potential study participants. After being informed of risks and benefits of participation, informed consent will be obtained. Patients will be randomized into two groups: the control group or experimental group. The patient will complete a brief questionnaire and pain assessment using a Visual Analog Scale (VAS).
Patients will be blinded. The investigators will be unblinded. The investigators will apply the jelly (lidocaine vs lubricating). The participant will have an equal chance of being in the control arm or experimental arm. After 5 minutes, the investigator will assess the patient's genital hiatus with valsalva and proceed with pessary removal per the investigator's routine. The patient will complete another VAS to indicate pain level after pessary removal. The investigator will perform a speculum exam per routine and then reinsert the pessary. The patient will complete a final VAS to indicate level of pain after pessary reinsertion along with a brief final questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Stress Urinary Incontinence
Keywords
Pessary, Lidocaine, Pain Reduction, Pessary Check, Pessary Removal, Pessary Reinsertion, Lubricating Jelly
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hcl 2% Jelly
Other Intervention Name(s)
Lidocaine Jelly
Intervention Description
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
Intervention Type
Drug
Intervention Name(s)
Placebo Jelly
Other Intervention Name(s)
Lubricating Gel, Vaginal Lubricant
Intervention Description
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Primary Outcome Measure Information:
Title
Change in patient's pain using the visual analog scale (VAS) after pessary removal
Description
Self-reported pain level at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Time Frame
0 and 5 minutes
Secondary Outcome Measure Information:
Title
Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion
Description
Self-reported pain level at time of pessary reinsertion controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)
Time Frame
0 and 10 minutes
Title
Genital Hiatus with Valsalva
Description
Genital hiatus measurement in centimeters prior to removal of the pessary
Time Frame
0 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women aged 18 years or older
Presenting for routine pessary management for prolapse, stress urinary incontinence, or both with a pessary in place
able to provide written informed consent
able to complete the visual analog scale
Exclusion Criteria:
Women less than 18 years of age.
Patients who speak neither English nor Spanish
Pregnancy
Medical contraindication to lidocaine
Planned change in pessary size or type
Patients who remove and reinsert their pessary at home
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Araba A Jackson, MD
Phone
(813) 974-5638
Email
AAjackson@usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araba A Jackson, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
USF Health Outpatient Urogynecology Clinics
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Mendez Herrera
First Name & Middle Initial & Last Name & Degree
Araba A Jackson, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15300365
Citation
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. doi: 10.1007/s00192-004-1163-7. Epub 2004 Aug 5.
Results Reference
background
PubMed Identifier
16030465
Citation
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. doi: 10.1097/00152192-200507000-00010.
Results Reference
background
PubMed Identifier
21575953
Citation
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.
Results Reference
background
PubMed Identifier
28594757
Citation
Taege SK, Adams W, Mueller ER, Brubaker L, Fitzgerald CM, Brincat C. Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):190-197. doi: 10.1097/AOG.0000000000002098.
Results Reference
background
PubMed Identifier
22417905
Citation
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.
Results Reference
background
PubMed Identifier
29455237
Citation
Ozel BZ, Sun V, Pahwa A, Nelken R, Dancz CE. Randomized controlled trial of 2% lidocaine gel versus water-based lubricant for multi-channel urodynamics. Int Urogynecol J. 2018 Sep;29(9):1297-1302. doi: 10.1007/s00192-018-3576-8. Epub 2018 Feb 17.
Results Reference
background
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Lidocaine for Pessary Check Pain Reduction
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