Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
66 participants
INTERVENTIONAL
2022-09-08
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.
Placebo Jelly
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Experimental
Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.
Lidocaine Hcl 2% Jelly
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
Interventions
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Lidocaine Hcl 2% Jelly
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
Placebo Jelly
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Araba A Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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USF Health Outpatient Urogynecology Clinics
Tampa, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Pro004522
Identifier Type: -
Identifier Source: org_study_id