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Bacterial Genomic Sequencing in Overactive Bladder

NCT ID: NCT01642277

Last Updated: 2015-12-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-08-31

Brief Summary

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No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown that female urine, even in the absence of culture evidence of bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine. From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin, a drug used to treat OAB, versus those that do not.

Detailed Description

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This is a prospective study with two groups: Women who have accepted a clinical recommendation for OAB treatment with solifenacin and a comparator (control) group of women unaffected by OAB. All women will have a baseline urine assessment with bacterial genome sequencing. Solifenacin treated patients will also have urine assessments with bacterial genomic sequencing at 4 and 12 weeks on treatment.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Women using Solifenacin for OAB treatment

Solifenacin treated women: Women with OAB who are prescribed solifenacin

Group Type EXPERIMENTAL

Solifenacin

Intervention Type DRUG

5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks

Control: Women without OAB

Women without OAB who are not prescribed solifenacin.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Solifenacin

5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks

Intervention Type DRUG

Other Intervention Names

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Vesicare

Eligibility Criteria

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Inclusion Criteria

Controls: Women without bother from urinary symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with negative urinary responses will be further screened for participation using the following eligibility criteria:

* no anticholinergic medications for bladder conditions,
* no antibiotic exposure in the past 4 weeks for any reason,
* no immunologic deficiency,
* no pelvic malignancy or pelvic radiation, and
* Untreated symptomatic POP \> POP-Q Stage II.

OAB cohort: Women with bother from overactive bladder symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with positive urinary responses for urge predominant symptoms will be further screened for participation using the following eligibility criteria:

* willing to take Solifenacin as treatment for OAB,
* no neurological disease known to affect the lower urinary tract,
* no current UTI (based on urine dipstick) or recurrent UTI,
* no antibiotic exposure in the past 4 weeks for any reason,
* no immunologic deficiency,
* no pelvic malignancy or pelvic radiation,
* untreated symptomatic POP \> POP-Q Stage II,
* no contraindications to receiving Solifenacin.

Exclusion Criteria

* Women who are of child-bearing potential who are pregnant, nursing, intending to become pregnant during the study or not practicing a reliable form of contraception are also excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Loyola University

OTHER

Sponsor Role lead

Responsible Party

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Alan J. Wolfe

Professor, Microbiology Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan J Wolffe, PhD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

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Loyola University Chicago Health Sciences Division

Maywood, Illinois, United States

Site Status

Countries

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United States

References

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Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

Reference Type BACKGROUND
PMID: 19941278 (View on PubMed)

Hartmann KE, McPheeters ML, Biller DH, Ward RM, McKoy JN, Jerome RN, Micucci SR, Meints L, Fisher JA, Scott TA, Slaughter JC, Blume JD. Treatment of overactive bladder in women. Evid Rep Technol Assess (Full Rep). 2009 Aug;(187):1-120, v.

Reference Type BACKGROUND
PMID: 19947666 (View on PubMed)

Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.

Reference Type BACKGROUND
PMID: 21231991 (View on PubMed)

de Boer TA, Salvatore S, Cardozo L, Chapple C, Kelleher C, van Kerrebroeck P, Kirby MG, Koelbl H, Espuna-Pons M, Milsom I, Tubaro A, Wagg A, Vierhout ME. Pelvic organ prolapse and overactive bladder. Neurourol Urodyn. 2010;29(1):30-9. doi: 10.1002/nau.20858.

Reference Type BACKGROUND
PMID: 20025017 (View on PubMed)

Sajadi KP, Vasavada SP. Overactive bladder after sling surgery. Curr Urol Rep. 2010 Nov;11(6):366-71. doi: 10.1007/s11934-010-0136-2.

Reference Type BACKGROUND
PMID: 20803179 (View on PubMed)

Mostwin JL. Pathophysiology: the varieties of bladder overactivity. Urology. 2002 Nov;60(5 Suppl 1):22-6; discussion 27. doi: 10.1016/s0090-4295(02)01788-0.

Reference Type BACKGROUND
PMID: 12493346 (View on PubMed)

Michel MC, Chapple CR. Basic mechanisms of urgency: roles and benefits of pharmacotherapy. World J Urol. 2009 Dec;27(6):705-9. doi: 10.1007/s00345-009-0446-5.

Reference Type BACKGROUND
PMID: 19588154 (View on PubMed)

Ohtake A, Sato S, Sasamata M, Miyata K. The forefront for novel therapeutic agents based on the pathophysiology of lower urinary tract dysfunction: ameliorative effect of solifenacin succinate (Vesicare), a bladder-selective antimuscarinic agent, on overactive bladder symptoms, especially urgency episodes. J Pharmacol Sci. 2010;112(2):135-41. doi: 10.1254/jphs.09r13fm. Epub 2010 Feb 4.

Reference Type BACKGROUND
PMID: 20134114 (View on PubMed)

Hoffstetter S, Leong FC. Solifenacin succinate for the treatment of overactive bladder. Expert Opin Drug Metab Toxicol. 2009 Mar;5(3):345-50. doi: 10.1517/17425250902762866.

Reference Type BACKGROUND
PMID: 19331596 (View on PubMed)

Pelman RS, Capo JP Jr, Forero-Schwanhaeuser S. Solifenacin at 3 years: a review of efficacy and safety. Postgrad Med. 2008 Jul;120(2):85-91. doi: 10.3810/pgm.2008.07.1795.

Reference Type BACKGROUND
PMID: 18654073 (View on PubMed)

Haab F, Cardozo L, Chapple C, Ridder AM; Solifenacin Study Group. Long-term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome. Eur Urol. 2005 Mar;47(3):376-84. doi: 10.1016/j.eururo.2004.11.004. Epub 2005 Jan 5.

Reference Type BACKGROUND
PMID: 15716204 (View on PubMed)

Santos JC, Telo ER. Solifenacin: scientific evidence in the treatment of overactive bladder. Arch Esp Urol. 2010 Apr;63(3):197-213. English, Spanish.

Reference Type BACKGROUND
PMID: 20431184 (View on PubMed)

Oliver JD. The viable but nonculturable state in bacteria. J Microbiol. 2005 Feb;43 Spec No:93-100.

Reference Type BACKGROUND
PMID: 15765062 (View on PubMed)

Wolfe AJ, Toh E, Shibata N, Rong R, Kenton K, Fitzgerald M, Mueller ER, Schreckenberger P, Dong Q, Nelson DE, Brubaker L. Evidence of uncultivated bacteria in the adult female bladder. J Clin Microbiol. 2012 Apr;50(4):1376-83. doi: 10.1128/JCM.05852-11. Epub 2012 Jan 25.

Reference Type BACKGROUND
PMID: 22278835 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26423260 (View on PubMed)

Pearce MM, Hilt EE, Rosenfeld AB, Zilliox MJ, Thomas-White K, Fok C, Kliethermes S, Schreckenberger PC, Brubaker L, Gai X, Wolfe AJ. The female urinary microbiome: a comparison of women with and without urgency urinary incontinence. mBio. 2014 Jul 8;5(4):e01283-14. doi: 10.1128/mBio.01283-14.

Reference Type DERIVED
PMID: 25006228 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24371246 (View on PubMed)

Other Identifiers

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204195

Identifier Type: -

Identifier Source: org_study_id