NCT02485808

Brief Summary

The purpose of this study is to advance our understanding of people who experience urinary and bladder problems. We are interested in learning about people's experiences with urinary symptoms and how these symptoms will be managed. We want to understand the important differences among people and what factors affect urinary and bladder problems. After all of the information is collected, we will have a better understanding of how to improve the care and treatment for people who have urinary and bladder problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,879

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

June 26, 2015

Last Update Submit

January 14, 2019

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract SymptomsBladder SymptomsOveractive BladderUrinary UrgencyLower Urinary Tract Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Clinically relevant subgroups of patients with lower urinary tract symptoms

    Identification of patient clusters based on their symptoms, clinical assessments, and/or other characteristics.

    Baseline

Secondary Outcomes (1)

  • Change in lower urinary tract symptoms

    baseline, 3 months, and 12 months

Study Arms (4)

Surgical

Men and women presenting for clinical care for whom surgical treatment of their lower urinary symptoms is planned. There will be no interventions, as this is an observational cohort.

Other: None-observational

Medical

Men and women presenting for clinical care for whom medical treatment of their lower urinary symptoms is planned. There will be no interventions, as this is an observational cohort.

Other: None-observational

Controls

Men and women who are not experiencing lower urinary tract symptoms. This group will undergo MRI, pain and auditory sensitivity testing.

Procedure: Magnetic Resonance Imaging (MRI)Other: Multimodal Automated Sensory Testing SystemOther: Auditory Sensitivity Test

Neuroimaging & Sensory Testing

Subjects from the Medical and Surgical Cohorts who agree to additional testing in the form of neuroimaging (via fMRI) and multimodal sensory testing. This group will undergo MRI, pain and auditory sensitivity testing.

Procedure: Magnetic Resonance Imaging (MRI)Other: Multimodal Automated Sensory Testing SystemOther: Auditory Sensitivity Test

Interventions

None-observationalOTHER

For surgical patients, follow-up assessments will occur 3 and 12 months after the surgery. For medical patients, follow-up assessments will occur 3 and 12 months after the baseline assessment.

MedicalSurgical
Magnetic Resonance Imaging (MRI)PROCEDURE

One time MRI scanning session examining brain structure and function in a resting state and after water consumption.

Also known as: MRI
ControlsNeuroimaging & Sensory Testing
Multimodal Automated Sensory Testing SystemOTHER

Pressure pain thresholds will be assess using computer-controlled pressures delivered by a device called the Multimodal Automated Sensory Testing System (MAST) device on to the subjects thumbnail bed.

Also known as: Pain Sensitivity
ControlsNeuroimaging & Sensory Testing
Auditory Sensitivity TestOTHER

Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.

ControlsNeuroimaging & Sensory Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

New patients with LUTS presenting to LURN clinical sites will be screened for participation based on the inclusion and exclusion criteria (below).

You may qualify if:

  • Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians.
  • Age ≥ 18 years.
  • The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period.
  • The ability to give informed consent and complete self-reported questionnaires electronically.
  • Daytime frequency
  • Nocturia
  • Urgency
  • Incontinence/leakage (various types)
  • Poor or absent sensation of bladder filling
  • Slow/weak stream
  • Splitting or spraying
  • Intermittent stream/Double voiding
  • Hesitancy
  • Straining
  • Dribbling at the end of flow
  • +5 more criteria

You may not qualify if:

  • Gross hematuria.
  • Significant neurologic disease or injury, including but not limited to: cerebral vascular accident with residual defect, Alzheimer's dementia, Parkinson's disease, traumatic brain injury, spinal cord injury, complicated spinal surgery, multiple sclerosis.
  • Primary complaint is pelvic pain.
  • Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia.
  • Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
  • Current sexually transmitted infection. (deferral; subject can enroll after negative culture)
  • Ongoing symptomatic urethral stricture.
  • History of lower urinary tract or pelvic malignancy.
  • Current chemotherapy or other cancer therapy.
  • Pelvic device or implant complication (e.g., sling or mesh complications).
  • Current functioning neurostimulator.
  • Botox injection to the bladder or pelvic structures within the preceding 12 months.
  • In men, prostate biopsy in the previous 3 months.
  • In women, pregnancy.
  • History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke University

Durham, North Carolina, 27715, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (8)

  • Coyne KS, Matza LS, Kopp ZS, Thompson C, Henry D, Irwin DE, Artibani W, Herschorn S, Milsom I. Examining lower urinary tract symptom constellations using cluster analysis. BJU Int. 2008 May;101(10):1267-73. doi: 10.1111/j.1464-410X.2008.07598.x. Epub 2008 Mar 11.

    PMID: 18336611BACKGROUND

  • Coyne KS, Barsdorf AI, Thompson C, Ireland A, Milsom I, Chapple C, Kopp ZS, Bavendam T. Moving towards a comprehensive assessment of lower urinary tract symptoms (LUTS). Neurourol Urodyn. 2012 Apr;31(4):448-54. doi: 10.1002/nau.21202. Epub 2012 Mar 6.

    PMID: 22396308BACKGROUND

  • Bower WF, Yip SK, Yeung CK. Dysfunctional elimination symptoms in childhood and adulthood. J Urol. 2005 Oct;174(4 Pt 2):1623-7; discussion 1627-8. doi: 10.1097/01.ju.0000176599.91836.12.

    PMID: 16148668BACKGROUND

  • Helmuth ME, Smith AR, Glaser AP, Yang CC, Cameron AP, Henry Lai H, Griffith JW, Eric Jelovsek J, Quentin Clemens J, Helfand BT, Merion RM, Andreev VP; and the LURN Study Group. Phenotyping Men With Lower Urinary Tract Symptoms: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network. Neurourol Urodyn. 2025 Jan;44(1):178-193. doi: 10.1002/nau.25596. Epub 2024 Oct 7.

    PMID: 39370868DERIVED

  • Lai HH, Rutlin J, Smith AR, Helmuth ME, Hokanson JA, Yang CC, Clemens JQ, Magnotta VA, Bretschneider CE, Kenton K, DeLancey JOL, John K, Kirkali Z, Shimony JS. Structural Changes in Brain White Matter Tracts Associated With Overactive Bladder Revealed by Diffusion Tensor Magnetic Resonance Imaging: Findings From a Symptoms of Lower Urinary Tract Dysfunction Research Network Cross-Sectional Case-Control Study. J Urol. 2024 Aug;212(2):351-361. doi: 10.1097/JU.0000000000004022. Epub 2024 May 8.

    PMID: 38717915DERIVED

  • Mawla I, Schrepf A, Kutch JJ, Helmuth ME, Smith AR, Ichesco E, Yang CC, Andreev VP, Kreder KJ, Bradley CS, Magnotta VA, Kirkali Z, Harris RE, Lai HH, Harte SE. Naturalistic Bladder Filling Reveals Subtypes in Overactive Bladder Syndrome That Differentially Engages Urinary Urgency-Related Brain Circuits: Results From the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). J Urol. 2024 Jan;211(1):111-123. doi: 10.1097/JU.0000000000003699. Epub 2023 Oct 5.

    PMID: 37796776DERIVED

  • Harte SE, Wiseman J, Wang Y, Smith AR, Yang CC, Helmuth M, Kreder K, Kruger GH, Gillespie BW, Amundsen C, Kirkali Z, Lai HH; LURN Study Group. Experimental Pain and Auditory Sensitivity in Overactive Bladder Syndrome: A Symptoms of the Lower Urinary Tract Dysfunction Research Network (LURN) Study. J Urol. 2022 Jan;207(1):161-171. doi: 10.1097/JU.0000000000002147. Epub 2022 Aug 25.

    PMID: 34428922DERIVED

  • Helmuth ME, Smith AR, Andreev VP, Liu G; LURN Study Group; Lai HH, Cameron AP, Siddiqui NY. Use of Euclidean length to measure urinary incontinence severity based on the lower urinary tract symptoms tool. Am J Obstet Gynecol. 2018 Mar;218(3):357-359. doi: 10.1016/j.ajog.2017.12.219. Epub 2017 Dec 26. No abstract available.

    PMID: 29288065DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood - DNA Plasma Urine Vaginal Cultures (women) Perineal Cultures (men) Saliva

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrinary Bladder, Overactive

Interventions

Magnetic Resonance SpectroscopyPain Threshold

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesPainSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kevin P Weinfurt, PhD

    Duke University

    STUDY CHAIR

  • Claire Yang, MD

    University of Washington

    STUDY CHAIR

  • Robert M Merion, MD, FACS

    Arbor Research Collaborative for Health - DCC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

June 30, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

We do not plan to make IPD available.

Locations

US(6)