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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reia Vaginal Pessary | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reia Vaginal Pessary | Device | Reia Vaginal Pessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The subject will be asked to Valsalva with their current pessary in place, and the distance from the leading edge of the current pessary to the hymen will be measured in centimeters. After the current pessary is removed and with the study pessary in place, the subject will be asked to Valsalva again. The distance from the leading edge of the study pessary to the hymen will be measured in centimeters. In order to assess the ability of the study pessary to function and be retained, the measurements will be compared. | During treatment - within 1 hour |
| The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) | With the study pessary in place, the subject will be asked to ambulate for 10 minutes and attempt to void. Following these activities, whether the pessary was retained or expelled will be recorded. | During treatment - within 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) | The subject will be asked to Valsalva. If the study device is expelled during Valsalva, whether the study device was expelled fully deployed or whether it prematurely folded to its collapsed state will be recorded. | During treatment - within 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kris Strohbehn, MD | Dartmouth-Hitchcock Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reia Vaginal Pessary | Reia Vaginal Pessary: Reia Vaginal Pessary |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reia Vaginal Pessary | Reia Vaginal Pessary: Reia Vaginal Pessary |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The subject will be asked to Valsalva with their current pessary in place, and the distance from the leading edge of the current pessary to the hymen will be measured in centimeters. After the current pessary is removed and with the study pessary in place, the subject will be asked to Valsalva again. The distance from the leading edge of the study pessary to the hymen will be measured in centimeters. In order to assess the ability of the study pessary to function and be retained, the measurements will be compared. | Posted | Median | Standard Deviation | cm | During treatment - within 1 hour |
|
Duration of subject's sole study visit - within one hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reia Vaginal Pessary | Reia Vaginal Pessary: Reia Vaginal Pessary | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaitlin Maier | Reia, LLC | 2032742886 | kaitlin@reiahealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2020 | Jan 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2020 | Jan 7, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2020 | Jan 7, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) | Following ambulation and attempting to void and prior to removing the study pessary, it will be recorded if the study device's stem rotated out of its original inserted position. | During treatment - within 1 hour |
| 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] | To indicate discomfort, the subject will be shown and asked to mark a visual analogue scale (VAS) after removal of her current pessary and before using the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon removal of the study pessary, the subject will be shown and asked to mark another VAS. In order to assess the discomfort experienced during removal of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome measure is [VAS after removal of current pessary] - [VAS after removal of study pessary]. | During treatment - within 1 hour |
| 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] | To indicate discomfort, the subject will be shown and asked to mark a VAS after insertion of the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon insertion of the subject's current pessary, the subject will also be shown and asked to mark another VAS. In order to assess the discomfort experienced during insertion of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome measure is [VAS after insertion of current pessary] - [VAS after insertion of study pessary]. | During treatment - within 1 hour |
| Global Comfort Associated With Use of the Study Pessary (by Verbal Description) | Following insertion of the subject's current pessary, and after the subject is dressed, she will be asked whether the study pessary was more, less, or as comfortable as her current pessary when it was in situ. If she responds it was more or less comfortable, she will be asked to describe why. | Post treatment - within or at 1 hour |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pessary type | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| Menopause status | Count of Participants | Participants |
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| Prolapse severity | POP-Q Stage - higher is worse. Prolapse stage recorded from chart abstraction from most recent clinical evaluation of prolapse stage. | Count of Participants | Participants |
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| Primary | The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) | With the study pessary in place, the subject will be asked to ambulate for 10 minutes and attempt to void. Following these activities, whether the pessary was retained or expelled will be recorded. | Posted | Number | participants | During treatment - within 1 hour |
|
|
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| Secondary | Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) | The subject will be asked to Valsalva. If the study device is expelled during Valsalva, whether the study device was expelled fully deployed or whether it prematurely folded to its collapsed state will be recorded. | Posted | Count of Participants | Participants | During treatment - within 1 hour |
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|
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| Secondary | Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) | Following ambulation and attempting to void and prior to removing the study pessary, it will be recorded if the study device's stem rotated out of its original inserted position. | Posted | Number | participants | During treatment - within 1 hour |
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|
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| Secondary | 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] | To indicate discomfort, the subject will be shown and asked to mark a visual analogue scale (VAS) after removal of her current pessary and before using the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon removal of the study pessary, the subject will be shown and asked to mark another VAS. In order to assess the discomfort experienced during removal of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome measure is [VAS after removal of current pessary] - [VAS after removal of study pessary]. | 1 subject arrived without current pessary in place, so no current pessary VAS removal score was recorded. | Posted | Mean | Inter-Quartile Range | cm | During treatment - within 1 hour |
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| Secondary | 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] | To indicate discomfort, the subject will be shown and asked to mark a VAS after insertion of the study pessary. The VAS will be a 10 centimeter linear continuum in which 0 represents no pain and 10 represents worst pain. After use of the study pessary and upon insertion of the subject's current pessary, the subject will also be shown and asked to mark another VAS. In order to assess the discomfort experienced during insertion of the study pessary, the distance from 0 to the subject's mark will be measured and compared between the two scales. The outcome measure is [VAS after insertion of current pessary] - [VAS after insertion of study pessary]. | 1 subject did not have current pessary reinserted due to discomfort with insertion of the current pessary. | Posted | Mean | Inter-Quartile Range | cm | During treatment - within 1 hour |
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| Secondary | Global Comfort Associated With Use of the Study Pessary (by Verbal Description) | Following insertion of the subject's current pessary, and after the subject is dressed, she will be asked whether the study pessary was more, less, or as comfortable as her current pessary when it was in situ. If she responds it was more or less comfortable, she will be asked to describe why. | Data was not collected by the study team for 1 subject. | Posted | Count of Participants | Participants | Post treatment - within or at 1 hour |
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| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| Title | Measurements |
|---|---|
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