Urinary IncontinencePhase 4NCT04090190

Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

A Phase 4 study testing Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine in people with Urinary Incontinence and Urgency Urinary, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older, women only
Conditions the study is for: Urinary Incontinence, Urgency Urinary
What is being tested?: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 30 Oct 2019to 31 Oct 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal (Age ≥ 50) women with Urgency Urinary Incontinence (UUI)
English speaking
Willing to take anticholinergics for at least 6 weeks
Willing to complete UDI-6 and voiding diary at baseline and 6 weeks
Willing to give urine and blood for study at baseline and 6 weeks

Who cannot join

Have taken anticholinergic medication within the last month
Have taken antibiotics within the last month
Urinary Tract Infection (UTI) in the last three months
Neurological disease (eg. Parkinson's disease, Multiple Sclerosis, etc.)
Immunological deficiencies
History of sexually transmitted disease (STD)
Lack of consent
Not ambulatory (e.g. uses a wheelchair)

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham & Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Urinary incontinence (UI) is a very common condition affecting women of all ages. The objective of this pilot study is to better understand the urinary microbiome and associated inflammatory markers in blood and urine in women with urgency UI. The study will assess how inflammation may affect response to standard of care anticholinergic medication treatment for urgency urinary incontinence.

Read the detailed description

This study is designed as a prospective pilot study of women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms who are offered treatment with a standard of care anticholinergic medication for six weeks. The patient will be asked to provide a catheterized urine sample at baseline and 6 weeks and blood draw only at baseline. Study participants will fill out a Urinary Distress Inventory-6 (UDI-6) questionnaire at baseline and fill a bladder diary for 48 hours before starting the anticholinergic medication.

The urine will be assessed by standard and enhanced urine cultures and DNA amplification and 16S rRNA sequencing for urinary microbiome along with inflammatory markers in the urine. Inflammatory markers in both the blood and urine will be measured using immunoenzyme assays.

Measurements for microbiome will be repeated for all patients at 6 weeks. Baseline urinary symptoms at enrollment and variation of symptoms after 6 weeks of anticholinergic treatment will be assessed using the UDI-6 questionnaire and a bladder diary.

Conditions: Urinary Incontinence, Urgency Urinary
Being tested: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine
Keywords: Urinary Incontinence, Urgency Urinary, Anticholinergic Treatment, Urinary Microbiome
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxybutynin, Solifenacin, Tolterodine, Trospium, or FesoterodineDrug
Also called Ditropan, Vesicare, Detrol, Sanctura
Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.

Study groups in NCT04090190
Study group	Role	What they receive
standard of care anticholinergic treatment	Other	Women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment Receives: Drug: Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine

What is being measured

The primary outcome is the main question the study is designed to answer.

Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Statistical testing was used to determine if there was a difference in inflammatory markers in the urine of patients between baseline visit and 6 week visit. 7 markers were chosen and compared, all inflammatory markers present in urine.
Measured: Baseline and 6 weeks

Secondary outcomes (2)

The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes.
The change in g_lactobacillus from Baseline to Follow-up (6 weeks), which corresponds to before and after anticholinergic treatment.
Measured: At the 6 week mark
The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
Symptoms taken from the UDI-6, a validated questionnaire for urogynecologic symptoms, were gathered at baseline for all patients. Duration of Urinary Incontinence symptoms is presented.
Measured: Baseline visit (0 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201931 Oct 2021

First posted16 Sep 2019
Study start30 Oct 2019
Primary completion30 May 2021
Study completion31 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04090190
Sponsor's protocol ID: 2018P000980
Status last verified: Oct 2022
First submitted: 21 Aug 2019
Last updated: 15 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Molinuevo B, Batista-Miranda JE. Under the tip of the iceberg: psychological factors in incontinence. Neurourol Urodyn. 2012 Jun;31(5):669-71. doi: 10.1002/nau.21216. Epub 2012 Mar 30.
PubMed 22473905
Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T. Costs of urinary incontinence and overactive bladder in the United States: a comparative study. Urology. 2004 Mar;63(3):461-5. doi: 10.1016/j.urology.2003.10.037.
PubMed 15028438
Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat Rev Genet. 2012 Mar 13;13(4):260-70. doi: 10.1038/nrg3182.
PubMed 22411464
Hilt EE, McKinley K, Pearce MM, Rosenfeld AB, Zilliox MJ, Mueller ER, Brubaker L, Gai X, Wolfe AJ, Schreckenberger PC. Urine is not sterile: use of enhanced urine culture techniques to detect resident bacterial flora in the adult female bladder. J Clin Microbiol. 2014 Mar;52(3):871-6. doi: 10.1128/JCM.02876-13. Epub 2013 Dec 26.
PubMed 24371246
Thomas-White KJ, Kliethermes S, Rickey L, Lukacz ES, Richter HE, Moalli P, Zimmern P, Norton P, Kusek JW, Wolfe AJ, Brubaker L; National Institute of Diabetes and Digestive and Kidney Diseases Urinary Incontinence Treatment Network. Evaluation of the urinary microbiota of women with uncomplicated stress urinary incontinence. Am J Obstet Gynecol. 2017 Jan;216(1):55.e1-55.e16. doi: 10.1016/j.ajog.2016.07.049. Epub 2016 Aug 4.
PubMed 27498309
Pearce MM, Zilliox MJ, Rosenfeld AB, Thomas-White KJ, Richter HE, Nager CW, Visco AG, Nygaard IE, Barber MD, Schaffer J, Moalli P, Sung VW, Smith AL, Rogers R, Nolen TL, Wallace D, Meikle SF, Gai X, Wolfe AJ, Brubaker L; Pelvic Floor Disorders Network. The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol. 2015 Sep;213(3):347.e1-11. doi: 10.1016/j.ajog.2015.07.009. Epub 2015 Jul 23.
PubMed 26210757
Thomas-White KJ, Hilt EE, Fok C, Pearce MM, Mueller ER, Kliethermes S, Jacobs K, Zilliox MJ, Brincat C, Price TK, Kuffel G, Schreckenberger P, Gai X, Brubaker L, Wolfe AJ. Incontinence medication response relates to the female urinary microbiota. Int Urogynecol J. 2016 May;27(5):723-33. doi: 10.1007/s00192-015-2847-x. Epub 2015 Sep 30.
PubMed 26423260

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
ClinicalTrials.gov ID: NCT04090190
Acronym / sponsor ID: 2018P000980
Conditions: Urinary Incontinence, Urgency Urinary
Keywords: Urinary Incontinence, Urgency Urinary, Anticholinergic Treatment, Urinary Microbiome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Medical University of Silesia
Study start: 30 Oct 2019 (actual)
Primary completion: 30 May 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 16 Sep 2019 (actual)
Results: Posted 3 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
standard of care anticholinergic treatment	Other	Drug: Oxybutynin, Solifenacin, Tolterodine, Trospium, or FesoterodineWomen presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Postmenopausal (Age ≥ 50) women with Urgency Urinary Incontinence (UUI)
English speaking
Willing to take anticholinergics for at least 6 weeks
Willing to complete UDI-6 and voiding diary at baseline and 6 weeks
Willing to give urine and blood for study at baseline and 6 weeks

Key exclusion criteria (8 listed)

Have taken anticholinergic medication within the last month
Have taken antibiotics within the last month
Urinary Tract Infection (UTI) in the last three months
Neurological disease (eg. Parkinson's disease, Multiple Sclerosis, etc.)
Immunological deficiencies

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
Oxybutynin, Solifenacin, Tolterodine, Trospium, or FesoterodineAlso: Ditropan, Vesicare, Detrol, SancturaStudy participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.	Drug	standard of care anticholinergic treatment

Primary outcome

Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Time frame: Baseline and 6 weeks
Statistical testing was used to determine if there was a difference in inflammatory markers in the urine of patients between baseline visit and 6 week visit. 7 markers were chosen and compared, all inflammatory markers present in urine.

2 secondary outcomes

The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes.
Time frame: At the 6 week mark
The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
Time frame: Baseline visit (0 weeks)

Results and safety

Results posted to the registry on 3 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care Anticholinergic Treatment	20	20

Primary outcome: Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.

Time frame: Baseline and 6 weeks. Median (Inter-Quartile Range). Unit: pg/mL

Measure	Standard of Care Anticholinergic Treatment n = 20
Baseline CRP	2.192 (1.902 to 2.867)
Follow-up CRP	2.565 (1.900 to 3.758)
Baseline IL-12/IL-23p40	2.192 (1.902 to 2.867)
Follow-up IL-12/IL-23p40	2.565 (1.900 to 3.758)
Baseline MCP-1	75.49 (55.69 to 117.85)
Follow-up MCP-1	65.02 (37 to 109.79)
Baseline GM-CSF	0.102 (0.06 to 0.122)
Follow-up GM CSF	0.203 (0.092 to 0.272)

Standard of Care Anticholinergic Treatment: p = 0.6497, Wilcoxon (Mann-Whitney)
Standard of Care Anticholinergic Treatment: p = 0.4281, Wilcoxon (Mann-Whitney)
Standard of Care Anticholinergic Treatment: p = 0.3157, Wilcoxon (Mann-Whitney)

Population analysed: 20 patients were involved in the study, however only 13 returned for follow-up, hence 13 patients involved in "follow-up" group.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected throughout the duration of any patient being involved in the study. Since no patients were involved for more than 1 year, data was collected for 1 year total to ensure any and all adverse event data were caught.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care Anticholinergic Treatment	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22473905Molinuevo B, Batista-Miranda JE. Under the tip of the iceberg: psychological factors in incontinence. Neurourol Urodyn. 2012 Jun;31(5):669-71. doi: 10.1002/nau.21216. Epub 2012 Mar 30.
Background: PubMed 15028438Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T. Costs of urinary incontinence and overactive bladder in the United States: a comparative study. Urology. 2004 Mar;63(3):461-5. doi: 10.1016/j.urology.2003.10.037.
Background: PubMed 22411464Cho I, Blaser MJ. The human microbiome: at the interface of health and disease. Nat Rev Genet. 2012 Mar 13;13(4):260-70. doi: 10.1038/nrg3182.
Background: PubMed 24371246Hilt EE, McKinley K, Pearce MM, Rosenfeld AB, Zilliox MJ, Mueller ER, Brubaker L, Gai X, Wolfe AJ, Schreckenberger PC. Urine is not sterile: use of enhanced urine culture techniques to detect resident bacterial flora in the adult female bladder. J Clin Microbiol. 2014 Mar;52(3):871-6. doi: 10.1128/JCM.02876-13. Epub 2013 Dec 26.
Background: PubMed 27498309Thomas-White KJ, Kliethermes S, Rickey L, Lukacz ES, Richter HE, Moalli P, Zimmern P, Norton P, Kusek JW, Wolfe AJ, Brubaker L; National Institute of Diabetes and Digestive and Kidney Diseases Urinary Incontinence Treatment Network. Evaluation of the urinary microbiota of women with uncomplicated stress urinary incontinence. Am J Obstet Gynecol. 2017 Jan;216(1):55.e1-55.e16. doi: 10.1016/j.ajog.2016.07.049. Epub 2016 Aug 4.
Background: PubMed 26210757Pearce MM, Zilliox MJ, Rosenfeld AB, Thomas-White KJ, Richter HE, Nager CW, Visco AG, Nygaard IE, Barber MD, Schaffer J, Moalli P, Sung VW, Smith AL, Rogers R, Nolen TL, Wallace D, Meikle SF, Gai X, Wolfe AJ, Brubaker L; Pelvic Floor Disorders Network. The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol. 2015 Sep;213(3):347.e1-11. doi: 10.1016/j.ajog.2015.07.009. Epub 2015 Jul 23.
Background: PubMed 26423260Thomas-White KJ, Hilt EE, Fok C, Pearce MM, Mueller ER, Kliethermes S, Jacobs K, Zilliox MJ, Brincat C, Price TK, Kuffel G, Schreckenberger P, Gai X, Brubaker L, Wolfe AJ. Incontinence medication response relates to the female urinary microbiota. Int Urogynecol J. 2016 May;27(5):723-33. doi: 10.1007/s00192-015-2847-x. Epub 2015 Sep 30.
Individual participant dataSharing planned: No

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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.

Vatche Minassian, MD, MPH principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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 15 Nov 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu. (time frame: Baseline and 6 weeks). 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 NCT04090190, which also lists 7 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 15 Nov 2022.