Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina

Stress Urinary Incontinence Clinical Trial

Official title:

Host Response to Pessaries in Microbial Communities of the Postmenopausal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605135
• Other study ID #: 207001
• Status: Completed
• Start date: April 2016
• Est. completion date: June 2018

Study information

• Verified date: January 2019
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 51 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Continued Pessary Use
Pessary Fitting

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (30)

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Brotman RM, Klebanoff MA, Nansel TR, Yu KF, Andrews WW, Zhang J, Schwebke JR. Bacterial vaginosis assessed by gram stain and diminished colonization resistance to incident gonococcal, chlamydial, and trichomonal genital infection. J Infect Dis. 2010 Dec 15;202(12):1907-15. doi: 10.1086/657320. Epub 2010 Nov 10. — View Citation

Brotman RM, Shardell MD, Gajer P, Fadrosh D, Chang K, Silver MI, Viscidi RP, Burke AE, Ravel J, Gravitt PE. Association between the vaginal microbiota, menopause status, and signs of vulvovaginal atrophy. Menopause. 2014 May;21(5):450-8. doi: 10.1097/GME.0b013e3182a4690b. — View Citation

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Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. — View Citation

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Collins S, Beigi R, Mellen C, O'Sullivan D, Tulikangas P. The effect of pessaries on the vaginal microenvironment. Am J Obstet Gynecol. 2015 Jan;212(1):60.e1-6. doi: 10.1016/j.ajog.2014.07.024. Epub 2014 Jul 18. — View Citation

Cundiff GW, Weidner AC, Visco AG, Bump RC, Addison WA. A survey of pessary use by members of the American urogynecologic society. Obstet Gynecol. 2000 Jun;95(6 Pt 1):931-5. — View Citation

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Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. — View Citation

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Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311. — View Citation

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Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729. — View Citation

Spear GT, Zariffard MR, Cohen MH, Sha BE. Vaginal IL-8 levels are positively associated with Candida albicans and inversely with lactobacilli in HIV-infected women. J Reprod Immunol. 2008 Jun;78(1):76-9. doi: 10.1016/j.jri.2007.11.001. Epub 2008 Feb 19. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predominant vaginal microorganisms of older women with and without a pessary	The investigator will collect a vaginal swab specimen in an aerobic and anaerobic preservative tube. Specimens will be sent to the clinical microbiology lab for quantitative culture. Expanded quantitative vaginal culture techniques and matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS).	Baseline
Secondary	Vaginal antimicrobial peptide (AMP) profile of older women with and without a pessary.	The investigator will collect vaginal lavage fluid (VLF) prior to pessary placement and after vaginal swabs are obtained. Assessing AMP activity using high pressure liquid chromatography fractionation and radial diffusion assay to assess for AMP activity and abundance of candidate AMPs (cathelicidin, beta defensisn (hBD1 and hBD2) psoriasin, lactoferrin).	Baseline
Secondary	Vaginal microbiome and AMP profile between those women that choose to continue pessary use and those that do not by correlating the data from Aim 1 and Aim 2 with the clinical characteristic of continued pessary use.	The investigator will collect vaginal swabs and the Vaginal Lavage Fluid for those subjects who decide to NOT have their pessaries replaced by correlating the data from outcome 1 and outcome 2 with the clinical characteristic of continued pessary use.	3 month visit, 6 month visit