Trial Outcomes & Findings for Feasibility Study of the Reia Vaginal Pessary (NCT NCT04508335)

Feasibility Study of the Reia Vaginal Pessary

The Pelvic Floor Distress Inventory - 20 (PFDI-20) is a validated instrument to assess the presence and bother of symptoms that pelvic floor disorders have on health-related quality of life in women. It is a 20-item questionnaire and the short form of the 46 question PFDI. There are three subscales: Urinary Distress Inventory 6 (UDI-6), Colorectal-Anal Distress Inventory 8 (CRADI-8), and the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6). The overall score range is 0-300. The higher the score, the greater the perceived impact that pelvic floor dysfunction has on a patient's life. The minimal important change in the PFDI-20 to demonstrate a clinical effect in women choosing conservative management of their prolapse (i.e. a pessary) is between 13.5 and 18.3 points.

Adverse events (AEs) reported by subjects and/or practitioners were recorded and categorized to conform to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 definition. AEs were then categorized into the groups as follows: New and/or worsening adverse events: AEs that were not present at baseline with the current pessary but developed with use of the Reia pessary, or that increased in severity with use of the Reia pessary. Improving adverse events: AEs that were present with the current pessary and decreased in severity or were no longer present with use of the Reia pessary. Persisting adverse events: AEs that were present both with the current pessary and with the Reia pessary but did not change in severity.

Pelvic Floor Impact Questionnaire-7 is a health-related quality of life instrument, designed to assess the life impact of pelvic floor symptoms in women with pelvic floor disorders. The PFIQ-7 has a parallel structure to the PFDI with 3 Scales: CRAIQ (Colorectal-Anal Impact Questionnaire), POPIQ (Pelvic Organ Prolapse Impact Questionnaire), and IIQ (Incontinence Impact Questionnaire). The PFIQ-7 summary score is calculated by adding the scores of the 3 scales (each range 0 - 100) together (total range 0 - 300). A lower score indicates a lesser life impact of pelvic floor symptoms.

A validated evaluation tool which can be used clinically as well as in research for assessment of female sexual function (FSF) in women with female pelvic floor disorders. The PISQ-IR contains 10 sub-scales. The first 4 sub-scales include questions for not sexually active (NSA) people and the following 6 sub-scales include questions for sexually active (SA) people. For not sexually active (NSA) people, higher scores indicate a greater impact of the condition on sexual activity. For sexually active (SA) people, higher scores indicate better sexual function. Transformed sums are reported (0 - 100) for each subscale.

POP-Q points Ba and Bp will be measured during physical exam, with the pessary in situ. Measurements were averaged to provide one Ba score and one Bp score for each subject for their current pessary and the Reia pessary. A more negative number indicates more support of the prolapse (better outcome). Ba ranges from -3 (more support of the prolapse) to 9 (less support of the prolapse). Bp ranges from -3 (more support of the prolapse) to 7 (less support of the prolapse).

Satisfaction will be assessed using a Visual Analog Scale (VAS) with a 100 mm linear continuum in which 0 represents no satisfaction and 100 represents complete satisfaction.

Pain will be assessed using a Visual Analog Scale (VAS) with a 100 mm linear continuum in which 0 represents no pain and 100 represents worst pain. Pain scores were averaged to create one pain with insertion of the current pessary and one pain with insertion of the Reia pessary score for each subject.

Pain will be assessed using a Visual Analog Scale (VAS) with a 100 mm linear continuum in which 0 represents no pain and 100 represents worst pain. Pain scores were averaged to create one pain with removal of the current pessary and one pain with insertion of the Reia pessary score for each subject.

Proportion of patients who were successfully fit with the study pessary.

The monthly frequency of pessary self-removal during the washout period will be compared against monthly frequency of self-removal in the treatment phase.

Difficulty of insertion was assessed using a visual analog scale (VAS) with a 100 mm linear continuum in which 0 represents very easy and 100 represents very difficult.

Difficulty of removal was assessed using a visual analog scale (VAS) with a 100 mm linear continuum in which 0 represents very easy and 100 represents very difficult.