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Clinical trial

Lidocaine for Pessary Removal and Reinsertion Pain Reduction

ID
Name
Pro004522
Description
The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.
Trial arms
Trial start
2022-09-08
Estimated PCD
2023-06-23
Trial end
2023-06-30
Status
Completed
Phase
Early phase I
Treatment
Lidocaine Hcl 2% Jelly
Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
Arms:
Experimental
Other names:
Lidocaine Jelly
Placebo Jelly
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Arms:
Control
Other names:
Lubricating Gel, Vaginal Lubricant
Size
66
Primary endpoint
Change in patient's pain using the visual analog scale (VAS) after pessary removal
0 and 5 minutes
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2023-12-14

1 organization

2 products

2 indications

Organization
University of South Florida
Product
Lidocaine Hcl 2% Jelly
Indication
Pelvic organ prolapse
Indication
urinary incontinence
Product
Placebo