Enabling Self-Care for Pessary Users in Rural Setting (ESCAPE)

Dartmouth Health

Status: Invitation-only

Conditions: Pelvic Organ Prolapse

Treatments: Device: Reia System pessary self-care management; Device: Standard pessary office-based management

Study type: Interventional

Funder types: Other

Identifiers

NCT07084818

02003005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)
• 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Self-Care

Experimental group

Description:

Subjects who switch to new, collapsible pessary and convert to self-management for care of their pelvic organ prolapse.

Treatment:

Device: Reia System pessary self-care management

Office-Care

Active Comparator group

Description:

Subjects who continue office-based pessary care of their pelvic organ prolapse with visits every 3-6 months annually.

Treatment:

Device: Standard pessary office-based management