Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina

Loyola University

Status: Completed

Conditions: Stress Urinary Incontinence; Prolapse

Treatments: Device: Continued Pessary Use

Study type: Observational

Funder types: Other

Identifiers

NCT02605135

207001

Details and patient eligibility

About

The ability to determine the postmenopausal vaginal environment and the impact of pessary use could help to maximize pessary therapy and non-surgical treatment for such a prevalent problem.

Full description

The study will advance the care of elderly patients through providing data to maximize non-surgical options to those at high risk for having surgery and its attending morbidity. In characterizing substantive differences in the vaginal environment of successful and unsuccessful pessary users, the investigators can identify elderly patients at higher risk of adverse events with pessary use as well as novel targets for the pharmacologic treatment of the altered vaginal microbiota and endogenous AMP levels, potentially allowing patients to continue with non-surgical therapies rather than pursuing surgical intervention.

Enrollment: 84 patients

Sex: Female

Ages: 51+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must be English speaking
• appropriate for pessary treatment
• pelvic floor conditions such as POP (with or without the presence of a uterus), stress urinary incontinence, urge urinary incontinence, or any combination of the above.

Exclusion criteria

• a history of current, symptomatic vaginal stricture
• a history of current, radiation therapy,
• or current treatment with auto-immune suppression agents.
• if they have eroded mesh in the vagina from prior pelvic floor surgery

Trial design

84 participants in 2 patient groups

Continued Pessary Use

Description:

All participants will undergo clinical testing prior to placement of the pessary and the investigator will test their vaginal environment prior to pessary placement. Testing will consists of a vaginal swab and 10 mL of vaginal lavage at each study visit. The participant will then be followed, and repeat testing obtained at the standard clinical interval for pessary follow-up, every three months

Treatment:

Device: Continued Pessary Use

Discontinued Pessary Use

Description:

All participants will undergo clinical testing prior to placement of the pessary and the investigator will test their vaginal environment prior to pessary placement. Testing will consists of a vaginal swab (AIM 1) and 10 mL of vaginal lavage (Aim 2) at each study visit. The participant will then be followed, and repeat testing obtained at the standard clinical interval for pessary follow-up, every three months. Should the participant discontinue pessary use, we will additionally culture the microbes that are present on the pessary and compare those to the vaginal microbiota.

Treatment:

Device: Continued Pessary Use