Pelvic Organ ProlapseESCAPENCT07084818
Enabling Self-Care for Pessary Users in Rural Setting
A study testing Reia System pessary self-care management and Standard pessary office-based management in people with Pelvic Organ Prolapse, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study is to see if a using new collapsible pessary (Reia pessary) for treatment of pelvic organ prolapse will allow patients to care for their prolapse on their own, rather than having to come to be seen by a provider in the office regularly (2-4 times per year) to manage the pessary. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Reia System pessary self-care management and Standard pessary office-based management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women currently using office-based pessary management of at least stage 2 POP will be recruited:
- English-speaking natal females 18 years or older
- Stage II-IV POP desiring continued pessary management.
- Primary indication for pessary management is treatment of POP
Who cannot join
- Primary indication for pessary is for management of stress urinary incontinence
- Vesicovaginal fistula or rectovaginal fistula
- Vaginal, rectal or bladder malignancy
- Genitourinary infection requiring treatment*
- Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis)*
- Inflammatory bowel disease (Crohn's or ulcerative colitis)
Show all 12Show fewer
- Pelvic or anorectal chronic pain
- Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery
- Congenital malformation of the bladder, rectum or vagina
- The following special populations will be excluded:
- Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women (or planning pregnancy in the next 6 months) (women of childbearing age will be verbally queried and offered pregnancy testing if uncertain) Prisoners
- Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment and have resolution of symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
This study is to see if a using new collapsible pessary (Reia pessary) for treatment of pelvic organ prolapse will allow patients to care for their prolapse on their own, rather than having to come to be seen by a provider in the office regularly (2-4 times per year) to manage the pessary. Enrollment in the study will be offered to current patients who have regular office visits to care for their pessary.
Read the detailed description
This is a prospective interventional trial for patients with at least stage 2 pelvic organ prolapse (POP), who are currently managing their POP with office-based care using a pessary. The study will be conducted at two institutions, Dartmouth-Hitchcock and Pennsylvania State University. The intervention will be to convert willing patients from office-based care to self-care, using a new, collapsible (Reia) pessary in patients. The primary outcome will be a visual analog score (VAS) regarding their current satisfaction with their treatment and management of POP. Secondary outcomes will include questionnaires on impact, travel for care and self-care. The comparison group will be patients who decline to try the new pessary but agree to questionnaires regarding their current office-based care for pessary management.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Reia System pessary self-care management, Standard pessary office-based management
- Keywords
- Pessary, Pelvic Organ Prolapse, Self-Care, Rural Care
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reia System pessary self-care managementDevice
Also called collapsible pessary
The Reia-System pessary is an FDA-cleared device to manage pelvic organ prolapse which is collapsible and intended to be more easily removed, with less discomfort.
Standard pessary office-based managementDevice
Also called Ring pessary, Gellhorn pessary, donut pessary, cube pessary
These subjects will continue with the current pessary they are using to manage their prolapse, with office-based care.
| Study group | Role | What they receive |
|---|---|---|
| Self-Care | Experimental | Subjects who switch to new, collapsible pessary and convert to self-management for care of their pelvic organ prolapse. Receives: Device: Reia System pessary self-care management |
| Office-Care | Active comparator | Subjects who continue office-based pessary care of their pelvic organ prolapse with visits every 3-6 months annually. Receives: Device: Standard pessary office-based management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score (VAS): satisfaction of prolapse management.
Patient reported Visual Analogue Score for (0-100mm) for satisfaction of prolapse management.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (9)
modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire
modified Patient Experience with Treatment and Self-Management Questionnaire. This is a 41-item questionnaire that is validated for patient experience with treatment and self-management of diseases as a measure of treatment burden. The questionnaire has been shortened from the original 48-item questionnaire in the original study by Eton et al and it has been slightly modified to address how prolapse and pessary care impacts treatment burden. Minimum value = 41, Maximum value = 205. Higher PETS scores are associated with greater treatment burden, with more distress, less satisfaction with medications, lower self-efficacy, worse physical and mental health, and lower convenience of healthcare.
Measured: Baseline, 6 months
Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire
Patient Experience with Pessary Treatment and Self-Management Questionnaire. This is a non-validated 11-item questionnaire that is focused on factual information regarding patient's care of their prolapse, including how long they have used a pessary, if they have cared for it themselves, how far they travel for care, how often they have their pessary checked by a practitioner. There are a few individual scaled questions with Likert responses, regarding discomfort of pessary removal and reinsertion (0-4, with the highest score being the worst outcome, "very uncomfortable"); bother of care for the pessary (0-5, the highest score being the worst outcome, "very bothersome"); interest in taking care of the pessary (0-5, the highest score being the worst outcome, "not interested at all". There is one visual analogue score (minimum 0, maximum 10) on how bothersome it is to have to travel for office care several times per year.
Measured: Baseline, 6 months
Pelvic Floor Impact Questionnaire - 7 (PFIQ-7)
Pelvic Floor Impact Questionnaire - 7. This is a validated 7-item questionnaire that assesses treatment on pelvic floor impact for urinary symptoms, prolapse symptoms and colorectal symptoms. Each of the seven questions for each symptom category (bladder, prolapse, rectal) has a scale of 0-3, with higher scores being worse. The total PFIQ-7 score range is 0-300, with the higher score being worse. It has been used in many studies on prolapse, including preliminary studies on the Reia pessary.
Measured: Baseline, 6 months
Pessary Sexual Questionnaire
This is a non-validated 8-item questionnaire on sexual activity for subjects and whether the pessary impacts ability to be sexually active. Most questions are informational yes/no responses. The last question is a Likert scale [0-3] regarding how much the current pessary interferes with being able to be sexually active, with 3 being worse, "interferes a lot".
Measured: Baseline, 6 months
Patient Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement: Validated one-item questionnaire (Likert scale, 1-7); The highest score is a worse outcome.
Measured: 3 months, 6 months
Patient Global Impression of Severity (PGI-S)
Patient Global Impression of Severity: Validated one-item assessment of severity of prolapse condition (Likert scale, 1-4). The highest score is a worse outcome.
Measured: Baseline, 3 months, 6 months
Patient Global Symptoms Rating Scale (PGSC)
Patient Global Symptoms Rating Scale (PGSC): Non-validated one-item questionnaire of treatment and adequacy of control of symptoms (Likert scale, 1-5); The highest score is a better outcome.
Measured: Baseline, 3 months, 6 months
Number of subjects with at least one adverse event
Adverse events will be collected, including discharge, bleeding, pain during the course of the study in both the intervention group and the continued office-based care group. There is not a maximum number of adverse events but a The highest number is a worse outcome.
Measured: 0-6 months
Log of pessary self-care events
Patients who decide to learn self-management of their pessary will record the number of times they remove and reinsert the pessary.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start10 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group will be subjects trying new collapsible pessary and providing self-care of their pessary. Control group will be subjects continuing with their current pessary and office-based care of their pessary.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Kris.Strohbehn, Dartmouth-Hitchcock Medical Center
- Investigators
- Kris Strohbehn, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084818
- Sponsor's protocol ID
- 02003005
- Acronym
- ESCAPE
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Strohbehn K, Wadensweiler PM, Richter HE, Grimes CL, Rardin CR, Rosenblatt PL, Toglia MR, Siddiqui G, Hanissian P. Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse. Am J Obstet Gynecol. 2024 Aug;231(2):271.e1-271.e10. doi: 10.1016/j.ajog.2024.05.009. Epub 2024 May 16.
PubMed 38761837Strohbehn K, Wadensweiler P, Hanissian P. A novel, collapsible, space-occupying pessary for the treatment of pelvic organ prolapse. Int Urogynecol J. 2023 Jan;34(1):317-319. doi: 10.1007/s00192-022-05415-y. Epub 2022 Dec 3. No abstract available.
PubMed 36462059Eton DT, Yost KJ, Lai JS, Ridgeway JL, Egginton JS, Rosedahl JK, Linzer M, Boehm DH, Thakur A, Poplau S, Odell L, Montori VM, May CR, Anderson RT. Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden. Qual Life Res. 2017 Feb;26(2):489-503. doi: 10.1007/s11136-016-1397-0. Epub 2016 Aug 26.
PubMed 27566732Chen X, Orom H, Hay JL, Waters EA, Schofield E, Li Y, Kiviniemi MT. Differences in Rural and Urban Health Information Access and Use. J Rural Health. 2019 Jun;35(3):405-417. doi: 10.1111/jrh.12335. Epub 2018 Nov 16.
PubMed 30444935Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
PubMed 16021067Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.
PubMed 20013110Kearney R, Brown C. Self-management of vaginal pessaries for pelvic organ prolapse. BMJ Qual Improv Rep. 2014 Oct 21;3(1):u206180.w2533. doi: 10.1136/bmjquality.u206180.w2533. eCollection 2014.
PubMed 27493737Dwyer L, Rajai A, Dowding D, Kearney R. Understanding Factors That Affect Willingness to Self-Manage a Pessary for Pelvic Organ Prolapse: A Questionnaire-Based Cross-Sectional Study of Pessary-Using Women in the UK. Int Urogynecol J. 2024 Aug;35(8):1627-1634. doi: 10.1007/s00192-024-05840-1. Epub 2024 Jul 2.
PubMed 38953998Sung VW, Jeppson P, Madsen A. Nonoperative Management of Pelvic Organ Prolapse. Obstet Gynecol. 2023 Apr 1;141(4):724-736. doi: 10.1097/AOG.0000000000005121. Epub 2023 Mar 9.
PubMed 36897185
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Self-Care for Pessary Users in Rural Setting
- ClinicalTrials.gov ID
- NCT07084818
- Acronym / sponsor ID
- ESCAPE / 02003005
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pessary, Pelvic Organ Prolapse, Self-Care, Rural Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to see if a using new collapsible pessary (Reia pessary) for treatment of pelvic organ prolapse will allow patients to care for their prolapse on their own, rather than having to come to be seen by a provider in the office regularly (2-4 times per year) to manage the pessary. Enrollment in the study will be offered to current patients who have regular office visits to care for their pessary.
Detailed description
This is a prospective interventional trial for patients with at least stage 2 pelvic organ prolapse (POP), who are currently managing their POP with office-based care using a pessary. The study will be conducted at two institutions, Dartmouth-Hitchcock and Pennsylvania State University. The intervention will be to convert willing patients from office-based care to self-care, using a new, collapsible (Reia) pessary in patients. The primary outcome will be a visual analog score (VAS) regarding their current satisfaction with their treatment and management of POP. Secondary outcomes will include questionnaires on impact, travel for care and self-care. The comparison group will be patients who decline to try the new pessary but agree to questionnaires regarding their current office-based care for pessary management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group will be subjects trying new collapsible pessary and providing self-care of their pessary. Control group will be subjects continuing with their current pessary and office-based care of their pessary.
| Arm | Type | Receives |
|---|---|---|
| Self-Care | Experimental | Device: Reia System pessary self-care managementSubjects who switch to new, collapsible pessary and convert to self-management for care of their pelvic organ prolapse. |
| Office-Care | Active comparator | Device: Standard pessary office-based managementSubjects who continue office-based pessary care of their pelvic organ prolapse with visits every 3-6 months annually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women currently using office-based pessary management of at least stage 2 POP will be recruited:
- English-speaking natal females 18 years or older
- Stage II-IV POP desiring continued pessary management.
- Primary indication for pessary management is treatment of POP
Key exclusion criteria (12 listed)
- Primary indication for pessary is for management of stress urinary incontinence
- Vesicovaginal fistula or rectovaginal fistula
- Vaginal, rectal or bladder malignancy
- Genitourinary infection requiring treatment*
- Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis)*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reia System pessary self-care managementAlso: collapsible pessaryThe Reia-System pessary is an FDA-cleared device to manage pelvic organ prolapse which is collapsible and intended to be more easily removed, with less discomfort. | Device | Self-Care |
| Standard pessary office-based managementAlso: Ring pessary, Gellhorn pessary, donut pessary, cube pessaryThese subjects will continue with the current pessary they are using to manage their prolapse, with office-based care. | Device | Office-Care |
Primary outcome
Visual Analogue Score (VAS): satisfaction of prolapse management.
Time frame: Baseline, 3 months, 6 months
Patient reported Visual Analogue Score for (0-100mm) for satisfaction of prolapse management.
9 secondary outcomes
modified Patient Experience with Treatment and Self-Management (mPETS) Questionnaire
Time frame: Baseline, 6 months
Patient Experience with Pessary Treatment and Self-Management (PEPS) Questionnaire
Time frame: Baseline, 6 months
Pelvic Floor Impact Questionnaire - 7 (PFIQ-7)
Time frame: Baseline, 6 months
Pessary Sexual Questionnaire
Time frame: Baseline, 6 months
Patient Global Impression of Improvement (PGI-I)
Time frame: 3 months, 6 months
Patient Global Impression of Severity (PGI-S)
Time frame: Baseline, 3 months, 6 months
Patient Global Symptoms Rating Scale (PGSC)
Time frame: Baseline, 3 months, 6 months
Number of subjects with at least one adverse event
Time frame: 0-6 months
Log of pessary self-care events
Time frame: 0-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 38761837Strohbehn K, Wadensweiler PM, Richter HE, Grimes CL, Rardin CR, Rosenblatt PL, Toglia MR, Siddiqui G, Hanissian P. Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse. Am J Obstet Gynecol. 2024 Aug;231(2):271.e1-271.e10. doi: 10.1016/j.ajog.2024.05.009. Epub 2024 May 16.
- Background: PubMed 36462059Strohbehn K, Wadensweiler P, Hanissian P. A novel, collapsible, space-occupying pessary for the treatment of pelvic organ prolapse. Int Urogynecol J. 2023 Jan;34(1):317-319. doi: 10.1007/s00192-022-05415-y. Epub 2022 Dec 3. No abstract available.
- Background: PubMed 27566732Eton DT, Yost KJ, Lai JS, Ridgeway JL, Egginton JS, Rosedahl JK, Linzer M, Boehm DH, Thakur A, Poplau S, Odell L, Montori VM, May CR, Anderson RT. Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden. Qual Life Res. 2017 Feb;26(2):489-503. doi: 10.1007/s11136-016-1397-0. Epub 2016 Aug 26.
- Background: PubMed 30444935Chen X, Orom H, Hay JL, Waters EA, Schofield E, Li Y, Kiviniemi MT. Differences in Rural and Urban Health Information Access and Use. J Rural Health. 2019 Jun;35(3):405-417. doi: 10.1111/jrh.12335. Epub 2018 Nov 16.
- Background: PubMed 16021067Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Background: PubMed 20013110Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.
- Background: PubMed 27493737Kearney R, Brown C. Self-management of vaginal pessaries for pelvic organ prolapse. BMJ Qual Improv Rep. 2014 Oct 21;3(1):u206180.w2533. doi: 10.1136/bmjquality.u206180.w2533. eCollection 2014.
- Background: PubMed 38953998Dwyer L, Rajai A, Dowding D, Kearney R. Understanding Factors That Affect Willingness to Self-Manage a Pessary for Pelvic Organ Prolapse: A Questionnaire-Based Cross-Sectional Study of Pessary-Using Women in the UK. Int Urogynecol J. 2024 Aug;35(8):1627-1634. doi: 10.1007/s00192-024-05840-1. Epub 2024 Jul 2.
- Background: PubMed 36897185Sung VW, Jeppson P, Madsen A. Nonoperative Management of Pelvic Organ Prolapse. Obstet Gynecol. 2023 Apr 1;141(4):724-736. doi: 10.1097/AOG.0000000000005121. Epub 2023 Mar 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kris Strohbehn, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reia System pessary self-care management and Standard pessary office-based management in people with Pelvic Organ Prolapse, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS): satisfaction of prolapse management. (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084818, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.