Clinical trial NCT05493735: Lidocaine for Pessary Check Pain Reduction
Official title: Lidocaine for Pessary Removal and Reinsertion Pain Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Stress Urinary Incontinence
Keywords: Pessary
Lidocaine
Pain Reduction
Pessary Check
Pessary Removal
Pessary Reinsertion
Lubricating Jelly
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in patient's pain using the visual analog scale (VAS) after pessary removal
timeFrame: 0 and 5 minutes
Secondary outcomes:
measure: Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion
timeFrame: 0 and 10 minutes
measure: Genital Hiatus with Valsalva
timeFrame: 0 minutes
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Health Outpatient Urogynecology Clinics
state: Florida
Study officials:
affiliation: University of South Florida
name: Araba A Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.