USF Health Outpatient Urogynecology Clinics
Tampa, Florida, 33606, United States
NCT Number: NCT05493735
The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.
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Notify Me18 year and older
Female
Interventional
Phase 3
Tampa, Florida, 33606, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
Other names: Lidocaine Jelly
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Other names: Lubricating Gel, Vaginal Lubricant
Time frame: 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)
Time frame: 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)
Time frame: 0 minutes
Genital hiatus measurement in centimeters prior to removal of the pessary
University of South Florida
Other
Lidocaine for Pessary Removal and Reinsertion Pain Reduction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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