NCT02605135

Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina

Host Response to Pessaries in Microbial Communities of the Postmenopausal

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 51 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Stress Urinary Incontinence
• Prolapse

Interventions

Type	Name	Description
DEVICE	Continued Pessary Use	Pessary Fitting

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-11-01
• Completion: 2018-06-01
• First posted: 2015-11-16
• Last updated: 2019-01-22

Locations

1 site across 1 country: United States