Stress Urinary IncontinenceNCT02605135
Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina
An observational study of Stress Urinary Incontinence and Prolapse, run by Loyola University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 51 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Prolapse
- What is being tested?
- Continued Pessary Use
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 51 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects must be female, postmenopausal, and have symptomatic pelvic floor disorders as evidenced by presenting to our tertiary care clinic.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Host Response to Pessaries in Microbial Communities of the Postmenopausal
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.
Read the 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
- Being tested
- Continued Pessary Use
- Medical subject headings
- Urinary Incontinence, Stress, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continued Pessary UseDevice
Pessary Fitting
| Study group | Role | What they receive |
|---|---|---|
| Continued Pessary Use | 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 Receives: Device: Continued Pessary Use | |
| Discontinued Pessary Use | 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. Receives: Device: Continued Pessary Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (2)
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).
Measured: Baseline
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.
Measured: 3 month visit, 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startApr 2016
- Primary completionNov 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Brincat, Loyola University
- Investigators
- Cynthia Brincat, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605135
- Sponsor's protocol ID
- 207001
- Status last verified
- Jan 2019
- First submitted
- 12 Nov 2015
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18799443Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjalmas K, Lapitan MC. Epidemiology and natural history of urinary incontinence in women. Urology. 2003 Oct;62(4 Suppl 1):16-23. doi: 10.1016/s0090-4295(03)00755-6.
PubMed 14550833Hendrix 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. doi: 10.1067/mob.2002.123819.
PubMed 12066091Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study. Br J Obstet Gynaecol. 1997 May;104(5):579-85. doi: 10.1111/j.1471-0528.1997.tb11536.x.
PubMed 9166201Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
PubMed 19935030Brown JS, Waetjen LE, Subak LL, Thom DH, Van den Eeden S, Vittinghoff E. Pelvic organ prolapse surgery in the United States, 1997. Am J Obstet Gynecol. 2002 Apr;186(4):712-6. doi: 10.1067/mob.2002.121897.
PubMed 11967496Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
PubMed 24807341Smith 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.
PubMed 20966694Sung VW, Weitzen S, Sokol ER, Rardin CR, Myers DL. Effect of patient age on increasing morbidity and mortality following urogynecologic surgery. Am J Obstet Gynecol. 2006 May;194(5):1411-7. doi: 10.1016/j.ajog.2006.01.050.
PubMed 16647926Cundiff 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. doi: 10.1016/s0029-7844(00)00788-2.
PubMed 10831995Aroutcheva A, Gariti D, Simon M, Shott S, Faro J, Simoes JA, Gurguis A, Faro S. Defense factors of vaginal lactobacilli. Am J Obstet Gynecol. 2001 Aug;185(2):375-9. doi: 10.1067/mob.2001.115867.
PubMed 11518895Brotman 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.
PubMed 24080849Brotman 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.
PubMed 21067371Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2.
PubMed 22073175Nizet V, Gallo RL. Cathelicidins and innate defense against invasive bacterial infection. Scand J Infect Dis. 2003;35(9):670-6. doi: 10.1080/00365540310015629.
PubMed 14620153
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Response to Pessaries in Microbial Communities of the Postmenopausal
- ClinicalTrials.gov ID
- NCT02605135
- Acronym / sponsor ID
- 207001
- Conditions
- Stress Urinary Incontinence, Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Nov 2015 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued Pessary Use | – | Device: Continued Pessary UseAll 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 |
| Discontinued Pessary Use | – | Device: Continued Pessary UseAll 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. |
Who may qualify
- Ages
- 51 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must be female, postmenopausal, and have symptomatic pelvic floor disorders as evidenced by presenting to our tertiary care clinic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Continued Pessary UsePessary Fitting | Device | Continued Pessary Use, Discontinued Pessary Use |
Primary outcome
Predominant vaginal microorganisms of older women with and without a pessary
Time frame: Baseline
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).
2 secondary outcomes
Vaginal antimicrobial peptide (AMP) profile of older women with and without a pessary.
Time frame: Baseline
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.
Time frame: 3 month visit, 6 month visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Background: PubMed 18799443Nygaard 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.
- Background: PubMed 14550833Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjalmas K, Lapitan MC. Epidemiology and natural history of urinary incontinence in women. Urology. 2003 Oct;62(4 Suppl 1):16-23. doi: 10.1016/s0090-4295(03)00755-6.
- Background: PubMed 12066091Hendrix 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. doi: 10.1067/mob.2002.123819.
- Background: PubMed 9166201Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study. Br J Obstet Gynaecol. 1997 May;104(5):579-85. doi: 10.1111/j.1471-0528.1997.tb11536.x.
- Background: PubMed 19935030Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
- Background: PubMed 11967496Brown JS, Waetjen LE, Subak LL, Thom DH, Van den Eeden S, Vittinghoff E. Pelvic organ prolapse surgery in the United States, 1997. Am J Obstet Gynecol. 2002 Apr;186(4):712-6. doi: 10.1067/mob.2002.121897.
- Background: PubMed 24807341Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
- Background: PubMed 20966694Smith 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.
- Background: PubMed 16647926Sung VW, Weitzen S, Sokol ER, Rardin CR, Myers DL. Effect of patient age on increasing morbidity and mortality following urogynecologic surgery. Am J Obstet Gynecol. 2006 May;194(5):1411-7. doi: 10.1016/j.ajog.2006.01.050.
- Background: PubMed 10831995Cundiff 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. doi: 10.1016/s0029-7844(00)00788-2.
- Background: PubMed 11518895Aroutcheva A, Gariti D, Simon M, Shott S, Faro J, Simoes JA, Gurguis A, Faro S. Defense factors of vaginal lactobacilli. Am J Obstet Gynecol. 2001 Aug;185(2):375-9. doi: 10.1067/mob.2001.115867.
- Background: PubMed 24080849Brotman 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Cynthia Brincat, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence and Prolapse, run by Loyola University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predominant vaginal microorganisms of older women with and without a pessary (time frame: Baseline). 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 NCT02605135, which also lists 30 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 22 Jan 2019.