Lidocaine for Pessary Check Pain Reduction

Pelvic Organ Prolapse Clinical Trial

Official title:

Lidocaine for Pessary Removal and Reinsertion Pain Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05493735
• Other study ID #: Pro004522
• Status: Completed
• Phase: Phase 3
• Start date: September 8, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 30, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	USF Health Outpatient Urogynecology Clinics	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	0 and 5 minutes
Secondary	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)	0 and 10 minutes
Secondary	Genital Hiatus with Valsalva	Genital hiatus measurement in centimeters prior to removal of the pessary	0 minutes