Pelvic Organ Prolapse, Prolapse
Conditions
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.
Interventions
DEVICEReia Vaginal Pessary
Reia Vaginal Pessary
Sponsors
Reia, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | During treatment - within 1 hour | 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. |
| The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) | During treatment - within 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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] | During treatment - within 1 hour | 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 \[VAS after removal of current pessary\] - \[VAS after removal of study pessary\]. |
| Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) | During treatment - within 1 hour | 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. |
| Global Comfort Associated With Use of the Study Pessary (by Verbal Description) | Post treatment - within or at 1 hour | 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. |
| 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] | During treatment - within 1 hour | 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 \[VAS after insertion of current pessary\] - \[VAS after insertion of study pessary\]. |
| Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) | During treatment - within 1 hour | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reia Vaginal Pessary Reia Vaginal Pessary: Reia Vaginal Pessary | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unable to be fit with Reia pessary | 1 |
Baseline characteristics
| Characteristic | Reia Vaginal Pessary |
|---|---|
| Age, Continuous | 78 years |
| BMI <20 | 1 Participants |
| BMI 20-30 | 9 Participants |
| BMI >30 | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Menopause status Post menopause | 15 Participants |
| Menopause status Pre menopause | 0 Participants |
| Pessary type Gellhorn | 8 Participants |
| Pessary type Ring | 7 Participants |
| Prolapse severity Stage II | 8 Participants |
| Prolapse severity Stage III | 5 Participants |
| Prolapse severity Stage IV | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: During treatment - within 1 hour
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Reia Vaginal Pessary | 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) | 0 cm | Standard Deviation 1.7 |
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.
Time frame: During treatment - within 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reia Vaginal Pessary | The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) | pessary expelled | 0 participants |
| Reia Vaginal Pessary | The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination) | pessary retained | 14 participants |
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 \[VAS after insertion of current pessary\] - \[VAS after insertion of study pessary\].
Time frame: During treatment - within 1 hour
Population: 1 subject did not have current pessary reinserted due to discomfort with insertion of the current pessary.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reia Vaginal Pessary | 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] | 1.3 cm |
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 \[VAS after removal of current pessary\] - \[VAS after removal of study pessary\].
Time frame: During treatment - within 1 hour
Population: 1 subject arrived without current pessary in place, so no current pessary VAS removal score was recorded.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reia Vaginal Pessary | 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] | 1.4 cm |
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.
Time frame: Post treatment - within or at 1 hour
Population: Data was not collected by the study team for 1 subject.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Reia Vaginal Pessary | Global Comfort Associated With Use of the Study Pessary (by Verbal Description) | Equal comfort | 6 Participants |
| Reia Vaginal Pessary | Global Comfort Associated With Use of the Study Pessary (by Verbal Description) | Current pessary more comfortable | 5 Participants |
| Reia Vaginal Pessary | Global Comfort Associated With Use of the Study Pessary (by Verbal Description) | Study pessary more comfortable | 2 Participants |
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.
Time frame: During treatment - within 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reia Vaginal Pessary | Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) | Rotated | 1 participants |
| Reia Vaginal Pessary | Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination) | Not rotated | 13 participants |
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.
Time frame: During treatment - within 1 hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Reia Vaginal Pessary | Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) | Not expelled | 14 Participants |
| Reia Vaginal Pessary | Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) | Expelled in collapsed state | 0 Participants |
| Reia Vaginal Pessary | Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination) | Expelled in deployed state | 0 Participants |