Pelvic Organ Prolapse, Stress Urinary Incontinence
Conditions
Keywords
Pessary, Lidocaine, Pain Reduction, Pessary Check, Pessary Removal, Pessary Reinsertion, Lubricating Jelly
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.
Interventions
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
DRUGPlacebo Jelly
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient's pain using the visual analog scale (VAS) after pessary removal | 0 and 5 minutes | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion | 0 and 10 minutes | 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) |
| Genital Hiatus with Valsalva | 0 minutes | Genital hiatus measurement in centimeters prior to removal of the pessary |
Countries
United States
Outcome results
None listed