N/A N=78 Treatment

Feasibility Study of the Reia Vaginal Pessary

Pelvic Organ Prolapse

Bottom Line

View on ClinicalTrials.gov: NCT04508335 ↗

Enrolled (actual)

Serious AEs

0.5%

Results posted

Nov 2024

Primary outcome: Primary: Pelvic Floor Distress Inventory-20 (PFDI-20) — 49.46; 62.75 score on a scale — p=.0021

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Reia Vaginal Pessary (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Reia, LLC
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Pelvic Floor Distress Inventory-20 (PFDI-20)	49.46; 62.75	.0021 sig
PRIMARY Adverse Events	4; 2; 1; 3; 10; 3	—
SECONDARY Pelvic Floor Impact Questionnaire (PFIQ-7)	32.23; 16.86	0.0192 sig
SECONDARY Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR)	64.0; 58.6; 24.0; 21.6; 28.4; 29.8	—
SECONDARY Objective Assessment of the Pessary's Ability to Support the Prolapse	-2.14; -1.60; -2.32; -2.29	—
SECONDARY Global Assessment of Study Pessary Satisfaction Compared to Current Pessary	69.68; 72.63	—
SECONDARY Pain Associated With Study Pessary Insertion Compared to Current Pessary	23.71; 13.80	—
SECONDARY Pain Associated With Study Pessary Removal Compared to Current Pessary	34.27; 23.04	—

Summary

The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ prolapse (POP) and have already opted for non-surgical management. Recruited patients will have Stage II POP or greater and will be current users of a Gellhorn or ring style pessary. Following enrollment, each subject will enter a 1-month wash out period in which they will continue using their current pessary so that baseline subjective and objective data can be collected. They will then be fit with a study pessary and enter a 3-month treatment phase. Comparative, subjective, and objective data will be collected at the conclusion of the study.

Eligibility Criteria

Inclusion Criteria

Females with Stage II pelvic organ prolapse or greater
Users of a Gellhorn or ring style pessary, inclusive of sizes 1.5"-3", for >3 months' duration
Capable of giving informed consent

Exclusion Criteria

Pregnancy Short vaginal length (total vaginal length < 8 cm), or subjective vaginal narrowing
Deep vaginal erosion noted with removal of current pessary
Presence of vesicovaginal fistula
Presence of rectovaginal fistula
Vaginal, rectal, or bladder tumor
Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
Untreated vaginal or urinary infection requiring treatment
History of recurrent urinary tract or vaginal infections
Inflammatory bowel disease
Chronic pain syndromes of pelvic or anorectal origin
Previous pelvic floor surgery in last 12 months
Congenital malformation of bladder, rectum, or vagina
Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, etc.)
Planning pregnancy in next 6 months
Previous treatment failure with a pessary

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04508335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.