Pelvic Organ Prolapse
Conditions
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.
Interventions
DEVICEReia Vaginal Pessary
Reia Vaginal Pessary
Sponsors
Reia, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Distress Inventory-20 (PFDI-20) | At enrollment [Week 0] and post treatment [Week 16] | 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 | Throughout study, an average of 16 weeks - AEs may be reported at any time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Assessment of the Pessary's Ability to Support the Prolapse | At enrollment [Week 0], during treatment [Week 3-5], during treatment [Week 5-7], and at the end of study [Week 16] | 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). |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | At enrollment [Week 0] and post treatment [Week 16] | 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. |
| Global Assessment of Study Pessary Satisfaction Compared to Current Pessary | For current pessary at the end of washout period [Week 3-5]; For study pessary post treatment [Week 16] | 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 Associated With Study Pessary Insertion Compared to Current Pessary | During treatment [Week 3-5], during treatment [Week 5-7], and post treatment [Week 16] | 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 Associated With Study Pessary Removal Compared to Current Pessary | During treatment [Week 3-5], during treatment [Week 5-7], and post treatment [Week 16] | 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. |
| Pelvic Floor Impact Questionnaire (PFIQ-7) | At enrollment [Week 0] and post treatment [Week 16] | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ease of Removal of Study Pessary by Subject for Self-managers | End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16] | 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. |
| Frequency of Pessary Removal for Self-managers | End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16] | The monthly frequency of pessary self-removal during the washout period will be compared against monthly frequency of self-removal in the treatment phase. |
| Ease of Insertion of Study Pessary by Subject for Self-managers | End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16] | 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. |
| Proportion of Patients Successfully Fit With the Study Pessary | Post treatment [Week 16] | Proportion of patients who were successfully fit with the study pessary. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reia Pessary Reia Pessary: Reia Pessary | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | Reia Pessary |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 64 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment United States | 78 participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 62 | 0 / 62 | 0 / 62 |
| other Total, other adverse events | 51 / 62 | 55 / 62 | 55 / 62 |
| serious Total, serious adverse events | 1 / 62 | 0 / 62 | 0 / 62 |
Outcome results
Primary
Adverse Events
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.
Time frame: Throughout study, an average of 16 weeks - AEs may be reported at any time
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reia Pessary | Adverse Events | Discomfort with Use | 13 participants |
| Reia Pessary | Adverse Events | Vaginal Bleeding | 17 participants |
| Reia Pessary | Adverse Events | Feeling of Obstructed Urination | 2 participants |
| Reia Pessary | Adverse Events | Urinary Incontinence | 4 participants |
| Reia Pessary | Adverse Events | Constipation | 3 participants |
| Reia Pessary | Adverse Events | Granulation Tissue | 14 participants |
| Reia Pessary | Adverse Events | Vaginal Irritation | 9 participants |
| Reia Pessary | Adverse Events | Sensation of Displacement | 15 participants |
| Reia Pessary | Adverse Events | Vaginal Abrasions | 12 participants |
| Reia Pessary | Adverse Events | Vaginal Discharge | 18 participants |
| Current Pessary | Adverse Events | Vaginal Abrasions | 4 participants |
| Current Pessary | Adverse Events | Vaginal Bleeding | 4 participants |
| Current Pessary | Adverse Events | Vaginal Discharge | 8 participants |
| Current Pessary | Adverse Events | Vaginal Irritation | 5 participants |
| Current Pessary | Adverse Events | Constipation | 10 participants |
| Current Pessary | Adverse Events | Discomfort with Use | 13 participants |
| Current Pessary | Adverse Events | Urinary Incontinence | 2 participants |
| Current Pessary | Adverse Events | Sensation of Displacement | 10 participants |
| Current Pessary | Adverse Events | Granulation Tissue | 4 participants |
| Current Pessary | Adverse Events | Feeling of Obstructed Urination | 12 participants |
| Persisting Across Pessary Type | Adverse Events | Vaginal Irritation | 2 participants |
| Persisting Across Pessary Type | Adverse Events | Feeling of Obstructed Urination | 3 participants |
| Persisting Across Pessary Type | Adverse Events | Granulation Tissue | 2 participants |
| Persisting Across Pessary Type | Adverse Events | Discomfort with Use | 10 participants |
| Persisting Across Pessary Type | Adverse Events | Urinary Incontinence | 1 participants |
| Persisting Across Pessary Type | Adverse Events | Sensation of Displacement | 10 participants |
| Persisting Across Pessary Type | Adverse Events | Vaginal Abrasions | 4 participants |
| Persisting Across Pessary Type | Adverse Events | Vaginal Bleeding | 8 participants |
| Persisting Across Pessary Type | Adverse Events | Vaginal Discharge | 19 participants |
| Persisting Across Pessary Type | Adverse Events | Constipation | 3 participants |
Primary
Pelvic Floor Distress Inventory-20 (PFDI-20)
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.
Time frame: At enrollment [Week 0] and post treatment [Week 16]
Population: All subjects treated with the Reia pessary were included in the analysis. Those subjects who withdrew after being treated with the Reia pessary (n = 14) were conservatively considered treatment failures and assigned the upper equivalence limit of 18.3 for the mean different (Reia Pessary - Current Pessary).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reia Pessary | Pelvic Floor Distress Inventory-20 (PFDI-20) | 49.46 score on a scale | Standard Deviation 43.2 |
| Current Pessary | Pelvic Floor Distress Inventory-20 (PFDI-20) | 62.75 score on a scale | Standard Deviation 42.3 |
Comparison: H01: μReia-μCurrent \> 18.3 and H02: μReia-μCurrent \< -18.3. The alternative hypothesis is thus: HA: -18.3 ≤ μReia-μCurrent ≤ 18.3.p-value: 0.0021t-test, 2 sided
Secondary
Global Assessment of Study Pessary Satisfaction Compared to Current Pessary
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.
Time frame: For current pessary at the end of washout period [Week 3-5]; For study pessary post treatment [Week 16]
Population: Only subjects who provided scores for both the current and Reia pessary (including 48 completers and 2 subjects who were treated but did not complete) were included in the analysis group. A negative difference (current pessary - Reia pessary) indicates more satisfaction, i.e., the Reia pessary provides more satisfaction than the current pessary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Global Assessment of Study Pessary Satisfaction Compared to Current Pessary | Current pessary | 69.68 mm | Standard Deviation 24.82 |
| Reia Pessary | Global Assessment of Study Pessary Satisfaction Compared to Current Pessary | Reia pessary | 72.63 mm | Standard Deviation 28.02 |
Secondary
Objective Assessment of the Pessary's Ability to Support the Prolapse
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).
Time frame: At enrollment [Week 0], during treatment [Week 3-5], during treatment [Week 5-7], and at the end of study [Week 16]
Population: A subject's Ba and Bp measurements were included in analysis if the subject had at least 1 data point for both the Reia pessary and their current pessary and did not drop out because of failure to fit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Objective Assessment of the Pessary's Ability to Support the Prolapse | Ba | -2.14 cm | Standard Deviation 0.95 |
| Reia Pessary | Objective Assessment of the Pessary's Ability to Support the Prolapse | Bp | -2.32 cm | Standard Deviation 0.95 |
| Current Pessary | Objective Assessment of the Pessary's Ability to Support the Prolapse | Ba | -1.60 cm | Standard Deviation 1.31 |
| Current Pessary | Objective Assessment of the Pessary's Ability to Support the Prolapse | Bp | -2.29 cm | Standard Deviation 0.93 |
Secondary
Pain Associated With Study Pessary Insertion Compared to Current Pessary
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.
Time frame: During treatment [Week 3-5], during treatment [Week 5-7], and post treatment [Week 16]
Population: Subjects' VAS pain scores were included in the analysis group if the subject has at least 1 data point for both the Reia pessary and their current pessary. For each subject with more than one data point, average pain scores for the current pessary and Reia pessary were calculated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Pain Associated With Study Pessary Insertion Compared to Current Pessary | Pain with insertion current pessary | 23.71 mm | Standard Deviation 26.58 |
| Reia Pessary | Pain Associated With Study Pessary Insertion Compared to Current Pessary | Pain with insertion Reia Pessary | 13.80 mm | Standard Deviation 15.82 |
Secondary
Pain Associated With Study Pessary Removal Compared to Current Pessary
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.
Time frame: During treatment [Week 3-5], during treatment [Week 5-7], and post treatment [Week 16]
Population: Subjects' VAS pain scores were included in the analysis group if the subject has at least 1 data point for both the Reia pessary and their current pessary. For each subject with more than one data point, average pain scores for the current pessary and Reia pessary were calculated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Pain Associated With Study Pessary Removal Compared to Current Pessary | Pain with removal study pessary | 23.04 mm | Standard Deviation 25.32 |
| Reia Pessary | Pain Associated With Study Pessary Removal Compared to Current Pessary | Pain with removal current pessary | 34.27 mm | Standard Deviation 30.04 |
Secondary
Pelvic Floor Impact Questionnaire (PFIQ-7)
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.
Time frame: At enrollment [Week 0] and post treatment [Week 16]
Population: Subjects who completed treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Pelvic Floor Impact Questionnaire (PFIQ-7) | PFIQ-7 score (current pessary) | 32.23 score on a scale | Standard Deviation 49.08 |
| Reia Pessary | Pelvic Floor Impact Questionnaire (PFIQ-7) | PFIQ score (Reia pessary) | 16.86 score on a scale | Standard Deviation 21.73 |
Comparison: PFIQ scores at baseline with subjects using current pessary then after treatment with Reia pessaryp-value: 0.0192Wilcoxon (Mann-Whitney)
Secondary
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR)
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.
Time frame: At enrollment [Week 0] and post treatment [Week 16]
Population: Subjects included in this analysis were those that completed the study and had a score for at least 1 sub-scale for both their current pessary and the Reia pessary. Subjects were not required to answer questions regarding their sexual activity to remain in the study. As sexual activity could change during course of the study data for the Reia pessary and current pessary are presented separately, not as a difference.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Global Quality | 28.4 score on a scale | Standard Deviation 22.9 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Condition Specific | 84.5 score on a scale | Standard Deviation 24.1 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Condition Specific | 24.0 score on a scale | Standard Deviation 27.6 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Partner Related | 76.1 score on a scale | Standard Deviation 18 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Desire | 45.4 score on a scale | Standard Deviation 14.1 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Condition Impact | 15.6 score on a scale | Standard Deviation 21.5 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Condition Imapct | 78.8 score on a scale | Standard Deviation 26.6 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Partner Related | 64.0 score on a scale | Standard Deviation 32.6 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Global Quality | 69.2 score on a scale | Standard Deviation 21.8 |
| Reia Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Arousal Orgasm | 68.6 score on a scale | Standard Deviation 14.4 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Global Quality | 65.8 score on a scale | Standard Deviation 25.4 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Partner Related | 58.6 score on a scale | Standard Deviation 28.7 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Condition Specific | 21.6 score on a scale | Standard Deviation 25.9 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Global Quality | 29.8 score on a scale | Standard Deviation 23.8 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Not Sexually Active - Condition Impact | 13.7 score on a scale | Standard Deviation 22.5 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Arousal Orgasm | 63.1 score on a scale | Standard Deviation 16.7 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Condition Specific | 94.1 score on a scale | Standard Deviation 9.2 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Desire | 44.0 score on a scale | Standard Deviation 13.9 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Condition Imapct | 76.1 score on a scale | Standard Deviation 25.1 |
| Current Pessary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA (International Urogynecological Association)-Revised (PISQ-IR) | Sexually Active - Partner Related | 76.9 score on a scale | Standard Deviation 23.4 |
Other Pre-specified
Ease of Insertion of Study Pessary by Subject for Self-managers
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.
Time frame: End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Ease of Insertion of Study Pessary by Subject for Self-managers | Difficulty of insertion current pessary | 33.89 mm | Standard Deviation 27.04 |
| Reia Pessary | Ease of Insertion of Study Pessary by Subject for Self-managers | Difficulty of insertion Reia pessary | 32.79 mm | Standard Deviation 25.85 |
Other Pre-specified
Ease of Removal of Study Pessary by Subject for Self-managers
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.
Time frame: End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]
Population: Discrepancy is due to more subjects self-managing the study pessary versus their current pessary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Ease of Removal of Study Pessary by Subject for Self-managers | Difficulty of removal Reia pessary | 23.36 mm | Standard Deviation 26.42 |
| Reia Pessary | Ease of Removal of Study Pessary by Subject for Self-managers | Difficulty of removal current pessary | 33.19 mm | Standard Deviation 29.14 |
Other Pre-specified
Frequency of Pessary Removal for Self-managers
The monthly frequency of pessary self-removal during the washout period will be compared against monthly frequency of self-removal in the treatment phase.
Time frame: End of washout period (current pessary use before treatment) [Weeks 3-5] and post treatment [Week 16]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reia Pessary | Frequency of Pessary Removal for Self-managers | Self management frequency current pessary | 3.07 number of times/month | Standard Deviation 7.36 |
| Reia Pessary | Frequency of Pessary Removal for Self-managers | Self management frequency Reia pessary | 2.57 number of times/month | Standard Deviation 4.86 |
Other Pre-specified
Proportion of Patients Successfully Fit With the Study Pessary
Proportion of patients who were successfully fit with the study pessary.
Time frame: Post treatment [Week 16]
Population: All subjects who completed the trial were considered successfully fit. For those who did not complete the trial, if the study team indicated that the reason for withdrawal is failure to fit or failure to retain, the subject was considered failed to fit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Reia Pessary | Proportion of Patients Successfully Fit With the Study Pessary | Subjects success fit | 59 Participants |
| Reia Pessary | Proportion of Patients Successfully Fit With the Study Pessary | Fit Failures | 3 Participants |