Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-10
Brief Title:
Patient Education in the Clinical Management of Pessary
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective randomized controlled single-blinded multi-center clinical trial Symptomatic patients with pelvic organ prolapse POP stage II III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group All patients will receive conventional verbalpaper instruction and counseling from a specialized doctor or nurse before pessary fitting and the experimental group will receive additional patient education in the form of a re-watchable video The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse tips and tricks for wearing and self-management of pessary possible adverse reactions and remedy All patients will receive regular pessary fitting and be followed up for 1 year Self-assessment questionnaires will be used to assess the patients willingness to pessary treatment anxiety status treatment satisfaction and efficacy and to assess the patients self-management complications and treatment adherence Then the differences between the two groups will be compared
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None