Clinical trial NCT04508335: Feasibility Study of the Reia Vaginal Pessary
Official title: Assessment of Effectiveness and Safety of a Novel Pessary for the Non-Surgical Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Reia, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this study is to evaluate the effectiveness, safety, function, and comfort of a novel vaginal pessary design for the treatment in women who suffer from of pelvic organ prolapse and who have already opted for non-surgical management. Results will be used to validate prior benchtop testing and to ensure the device performs as anticipated in the real-world environment and does not cause harm. Treatment intervention will be non-blinded to the patient and investigator. Patients will serve as their own controls and enter the treatment phase of the study after a 1-month washout period of using their current pessary. The primary outcome measure will be the change in the scores of the Pelvic Floor Distress Inventory-20 (PFDI-20), administered first during the washout period while still using their current pessary and then at the conclusion of the treatment phase with the study pessary. The PFDI-20 is a validated health-related quality of life instrument to assess the presence and bother of symptoms in women with pelvic floor dysfunction. For women with relatively mild pelvic floor symptoms, a minimal important change (MIC) of between 13.5 and 18.3 points in the PFDI-20 score can be considered clinically relevant. We plan to have at least 40 subjects complete the study. This provides power of .80 for a MIC equivalence limit of 17 points on the PFDI-20 scale. The safety outcome is the prevalence and severity of adverse events that patients experience using the study pessary compared to those experienced with their current pessary. Comparative measurements (in cm) of the most dependent compartment of prolapse in relation to the hymen when using the current and study pessary will be taken to objectively assess function. Comfort will be assessed using a Visual Analogue Scale (VAS - a 10cm linear continuum in which 0 represents no pain and 10 represents worst pain) administered with pessary insertion and removal. Other secondary outcome measures will include global patient satisfaction of the current and study pessary using VAS, percent of patients successfully fit with the study pessary, change in the Pelvic Floor Impact Questionnaire scores between current and study pessary use (the PFIQ is a separate health-related quality of life instrument designed to assess the life impact of pelvic floor symptoms in women with pelvic floor disorders), change in frequency of pessary removal for those patients who insert and remove their pessary outside of medical care (self-managers), and study dropout rates.

The study will take place over 3-4 visits (Visit 0, Visit 1, Visit 2, and Visit 3).

Visit 0 will involve screening, enrollment, and consent. A baseline physical exam will be conducted to assess for pre-existing vaginal adverse events (ecchymoses, abrasions, superficial cuts, erosions, or bleeding) associated with their current pessary use, as well as to assess the ability of their current pessary to support their prolapse by measuring the distance of the most dependent compartment of their prolapse to the hymen. This visit is routinely scheduled for all pessary users and not additional for those consenting to study participation. There will be a washout period where they continue use of their current pessary during which they will complete the PFDI-20, the Pelvic Floor Impact Questionnaire (PFIQ), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR). Patients who insert and remove their current pessary outside of medical care (self-managers) will track the frequency of removals.

Visit 1 will occur after one month, the conclusion of the washout period. Demographic and historical data will be extracted from the Electronic Medical Record (EMR) and supplemented by the patient as needed. Global patient satisfaction of the current pessary will be assessed using a Visual Analog Scale (VAS). The current pessary will be removed, physical exam will be repeated as in Visit 0, and the presence of perineal disruption associated current pessary removal will be noted. The patient will be fit with the study pessary (which will be used until the study is complete). A VAS will be used to assess the perceived discomfort with removal of the current pessary, and with insertion of the study pessary. For self-managers, teaching will be provided on the proper technique to insert and remove the study pessary and ease of their current pessary removal and reinsertion will be noted using VAS. This visit is additional for those electing to be in the study. A gift card will be offered to compensate for time and travel.

Visit 2 will be scheduled within 1-3 weeks of Visit 1. Visit 2 may be optional at the discretion of the study team. A member of the study team will call the subject ahead of the scheduled Visit 2 to review the subject's experience with the study pessary and adverse events. If the subject has not experienced any complications and the pessary has not dislodged, the study team and subject can decide to omit the in-person Visit 2. The purpose of this visit is to minimize unforeseeable risks associated with use of the study pessary and/or to refit a subject with a study pessary if the original one was expelled or could not be inserted during Visit 1. If Visit 2 occurs in-person, physical exam will be performed to assess for vaginal pathology (ecchymoses, abrasions, superficial cuts, erosions, granulation tissue or bleeding) or urinary retention related to the study pessary, and all adverse events will be recorded. The study pessary will be observed in situ for the presence of rotation and its ability to support prolapse by measuring the distance of the most dependent compartment of the subject's prolapse to the hymen, as well as the distance from the leading edge of the study pessary to the hymen. Those subjects who were not successfully fit with a study pessary in their first visit would be fit with a larger study pessary.

Visit 3 will occur at the conclusion of the 3-month (from Visit 1) treatment phase - a typical length of time between routine visits for patients who choose long term pessary management of their prolapse. When the subject returns for Visit 3, a physical exam will be repeated, as in previous visits, for comparative data. The study pessary will be observed in situ for the presence of rotation and its ability to support prolapse by measuring the distance of the most dependent compartment of the subject's prolapse to the hymen (Points Ba and Bp), as well as the distance from the leading edge of the study pessary to the hymen. A VAS will be used to assess discomfort with removal of the study pessary, discomfort with reinsertion of their current pessary, and their global satisfaction of the study pessary. The subject will have been instructed to return with her current pessary which was removed in Visit 1. If the subject's current pessary is not brought to the visit, she will be given a new pessary of the size and style of her current pessary. Each subject will complete the PFDI-20, PFIQ-7, and PISQ-IR for a post treatment comparison. For self-managers, other data collected will include frequency of removal and a VAS for ease of study pessary insertion and removal.

Specific adverse events (in addition to those described above as part of the physical exam) which will be tracked include pelvic cramping or mild discomfort, bothersome vaginal discharge, urinary tract infection, urinary retention, substantial discomfort, pessary expulsion (deployed or collapsed), pessary failure to deploy or collapse, or adverse event unrelated to the pessary or study visits. Each event will be classified as mild (transient and easily tolerated by the patient), moderate (causing discomfort or interrupting usual activities), or severe (causing considerable interference with usual activities, may be incapacitating, or may require hospitalization). The patient will be instructed to call the triage nursing staff at any point with questions or to report adverse events. The frequency of additional phone calls and any extra visits related to study participation will be tracked. The patient may withdraw from the study and any point upon request.

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

Primary outcomes:
measure: Pelvic Floor Distress Inventory-20 (PFDI-20)
timeFrame: At enrollment [Week 0] and post treatment [Week 16]
measure: Adverse Events
timeFrame: Throughout study, an average of 16 weeks - AEs may be reported at any time
Secondary outcomes:
measure: Pelvic Floor Impact Questionnaire (PFIQ-7)
timeFrame: At enrollment [Week 0] and post treatment [Week 16]
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR)
timeFrame: At enrollment [Week 0] and post treatment [Week 16]
measure: Objective Assessment of the Pessary's Ability to Support the Prolapse
timeFrame: At enrollment [Week 0], during treatment [Week 3-5], during treatment [Week 5-7], and at the end of study [Week 16]
measure: Global Assessment of Study Pessary Satisfaction Compared to Current Pessary
timeFrame: For current pessary at the end of washout period [Week 3-5]; For study pessary post treatment [Week 16]
measure: Pain Associated With Study Pessary Insertion Compared to Current Pessary
timeFrame: During treatment [Week 3-5], during treatment [Week 5-7], and post treatment [Week 16]
measure: Pain Associated With Study Pessary Removal Compared to Current Pessary
timeFrame: During treatment [Week 3-5], during treatment [Week 5-7], and post treatment [Week 16]
Other outcomes:
measure: Proportion of Patients Successfully Fit With the Study Pessary
timeFrame: Post treatment [Week 16]
measure: Frequency of Pessary Removal for Self-managers
timeFrame: End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]
measure: Ease of Insertion of Study Pessary by Subject for Self-managers
timeFrame: End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]
measure: Ease of Removal of Study Pessary by Subject for Self-managers
timeFrame: End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Cambridge
country: United States
facility: Boston Urogynecology Associates
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hawthorne
country: United States
facility: New York Medical College
state: New York
city: Media
country: United States
facility: Main Line Health
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
city: Houston
country: United States
facility: UTHealth
state: Texas
Study officials:
affiliation: Dartmouth-Hitchcock Clinic
name: Kris Strohbehn, MD
role: PRINCIPAL_INVESTIGATOR
References: