Lidocaine for Pessary Check Pain Reduction

University of South Florida

Status and phase: Completed; Phase 3

Conditions: Stress Urinary Incontinence; Pelvic Organ Prolapse

Treatments: Drug: Placebo Jelly; Drug: Lidocaine Hcl 2% Jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT05493735

Pro004522

Details and patient eligibility

About

The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Jelly

Experimental

Experimental group

Description:

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

Treatment:

Drug: Lidocaine Hcl 2% Jelly