Lidocaine for Pessary Check Pain Reduction

NCT05493735 | Completed Phase 3 FDA Drug

• 1 other identifier: Pro004522
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Stress Urinary Incontinence

Keywords

Pessary; Lidocaine; Pain Reduction; Pessary Check; Pessary Removal; Pessary Reinsertion; Lubricating Jelly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion

  0 and 10 minutes

• Genital Hiatus with Valsalva

  0 minutes

Study Arms (2)

Control

PLACEBO COMPARATOR

Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.

Drug: Placebo Jelly

Experimental

EXPERIMENTAL

Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.

Drug: Lidocaine Hcl 2% Jelly

Interventions

Lidocaine Hcl 2% Jelly DRUG

Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.

Also known as: Lidocaine Jelly

Experimental

Placebo Jelly DRUG

Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.

Also known as: Lubricating Gel, Vaginal Lubricant

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

USF Health Outpatient Urogynecology Clinics

Tampa, Florida, 33606, United States

Location

Related 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.

  PMID: 15300365 BACKGROUND

• 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.

  PMID: 16030465 BACKGROUND

• 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.

  PMID: 21575953 BACKGROUND

• 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.

  PMID: 28594757 BACKGROUND

• 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.

  PMID: 22417905 BACKGROUND

• 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.

  PMID: 29455237 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Interventions

Lidocaine; Gels

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Araba A Jackson, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 9, 2022
• Study Start: September 8, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 30, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)