Lidocaine for Pessary Check Pain Reduction

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05493735
Study type	Interventional
Source	University of South Florida
Contact
Status	Completed
Phase	Phase 3
Start date	September 8, 2022
Completion date	June 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05420831` - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment	N/A
Active, not recruiting	`NCT05422209` - The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.	N/A
Completed	`NCT06126328` - Materna Prep Study Phase II	Phase 2
Recruiting	`NCT05542836` - EVeRLAST 2-Year Follow-Up
Recruiting	`NCT05918367` - Multicenter Ventral Mesh Rectopexy Registry Collaborative
Recruiting	`NCT04172272` - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	N/A
Recruiting	`NCT04807920` - BOTOX® at the Time of Prolapse Surgery for OAB	Phase 4
Completed	`NCT06268782` - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women	N/A
Recruiting	`NCT03146195` - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease	N/A
Recruiting	`NCT02919852` - Laparoscopic Retrovesical Colpopectinopexia	N/A
Completed	`NCT02925585` - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting	`NCT02536001` - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes	N/A
Recruiting	`NCT02113969` - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol	N/A
Completed	`NCT02383199` - Polypropylene Mesh in Prolapse Surgery	N/A
Terminated	`NCT01673360` - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices	N/A
Withdrawn	`NCT01530191` - Factors Affecting Perioperative Outcomes	N/A
Completed	`NCT01842464` - Sacro-Spinous Ligaments Anterior Apical Anchoring	N/A
Completed	`NCT01320631` - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction	N/A
Completed	`NCT00581412` - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates	N/A
Completed	`NCT00551993` - Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse	N/A