Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634459
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
POMEGRANATE Trial Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The POMEGRANATE Trial a Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POMEGRANATE
Brief Summary:
This multi-centered randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System RS which includes the Reia pessary and applicator compared to standard pessary care Gellhorn or ring withwithout support without knob among women with stage II-IV pelvic organ prolapse POP A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery URPS Participants will be assigned via 11 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention the Reia System RS or standard pessary care SPC stratified by site Participation in this trial will involve a total of four visits over six months The primary outcome measure will be the number of successful self-managed pessary removal events completed over the six-month time frame Secondary outcomes will include validated surveys to assess quality of life adverse events and satisfaction with treatment
Specific Aims
Aim 1 To compare number of self-management events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Aim 2 To assess successful fitting number of refitting visits and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Aim 3 To compare satisfaction with treatment and quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Aim 4 To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Specific Aims
Aim 1 To compare number of self-management events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Aim 2 To assess successful fitting number of refitting visits and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Aim 3 To compare satisfaction with treatment and quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Aim 4 To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None