Clinical trial NCT04275089: Early Feasibility Study of the Reia Vaginal Pessary
Official title: Early Feasibility Prospective Open-Label Study to Assess the Function of a Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Prolapse
Lead sponsor: Reia, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-19
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.


Eligibility criteria: Inclusion Criteria:

* Women with Stage II pelvic organ prolapse or greater
* Current ring style or Gellhorn pessary users inclusive of sizes 1.5"-3.5"
* Capable of giving informed consent

Exclusion Criteria:

* Pregnancy
* Deep vaginal erosion noted with removal of current pessary
* Presence of vesicovaginal fistula
* Presence of rectovaginal fistula
* Vaginal, rectal, or bladder tumor
* Inflammatory Bowel Disease
* Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
* Current vaginal or urinary infection requiring treatment
* 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

Primary outcomes:
measure: The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in Distance Between Current Pessary and Study Pessary to Leading Edge to the Hymen)
timeFrame: During treatment - within 1 hour
measure: The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)
timeFrame: During treatment - within 1 hour
Secondary outcomes:
measure: Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)
timeFrame: During treatment - within 1 hour
measure: Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)
timeFrame: During treatment - within 1 hour
measure: Discomfort Experienced With Removal of the Study Pessary Subtracted From the Discomfort Experienced With Removal of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary]
timeFrame: During treatment - within 1 hour
measure: Discomfort Experienced With Insertion of the Study Pessary Subtracted From the Discomfort Experienced With Insertion of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary]
timeFrame: During treatment - within 1 hour
measure: Global Comfort Associated With Use of the Study Pessary (by Verbal Description)
timeFrame: Post treatment - within or at 1 hour
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Clinic
name: Kris Strohbehn, MD
role: PRINCIPAL_INVESTIGATOR
References: