Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study

January 14, 2019 updated by: Arbor Research Collaborative for Health

Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Phenotyping Study Protocol

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.

Study Overview

Detailed Description

The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to advance our understanding of lower urinary tract dysfunction (LUTD) in women and men. LUTD is a term intended to be comprehensive and to challenge current paradigms about how symptomatic pelvic disorders are defined as 'diseases.' Lower urinary tract symptoms (LUTS) are likely caused and exacerbated by a variety of factors and thus do not represent the manifestation of a single disease. Clinical management of LUTD, including treatment outcomes, remains suboptimal since the biological and psychosocial factors that initiate, exacerbate, and modify this group of symptoms remain largely unknown. As an initial effort to better characterize the biological and psychosocial factors that initiate, exacerbate, and modify LUTS, the LURN investigators will establish a prospective Observational Cohort Study of men and women with LUTS presenting for the first time to LURN physicians.

Information to be obtained from study participants initially (at time of enrollment) includes a standardized clinical examination, medical history, select testing of the lower urinary tract, and participants' self-report of LUTS, pelvic floor symptoms including sexual function and bowel symptoms, depression, anxiety, sleep patterns, stress, metabolic risk factors, and health-related quality of life. We will also collect serum, urine, saliva, and perineal swabs from men and vaginal swabs from women for storage at the NIDDK Sample Repository for future study by the LURN investigators and the broader research community. This information will be used to construct subgroups of patients who have similar symptoms, clinical presentations, comorbidities, pelvic floor dysfunctions, and psychological profiles. These patient characteristics and behaviors likely affect the evaluation, diagnosis, and/or treatment of LUTS. Additional information will be collected 3 months and 12 months after enrollment or 3 and 12 months after surgery for patients receiving surgical treatment, and will include an interval clinical history, participants' self-report of LUTS, pelvic floor symptoms including sexual function and bowel symptoms, depression, anxiety, and health-related quality of life. We will also collect biological samples at 3 and 12 months after enrollment.

The LURN Neuroimaging and Sensory Testing component of the study will investigate abnormal sensation of the lower urinary tract at the level of the organism. Subjects and controls will have a one-time visit soon after their baseline visit, where they will undergo an fMRI scan of their brain and multimodal quantitative sensory testing assessing perceptual responses to physical stimuli (pain and sound).

The information to be collected from the prospective Observational Cohort Study will be limited and not sufficient to fully understand the pathophysiology and biology of LUTS. Therefore, the Observational Cohort Study will serve as the basis for further LURN studies. The long-term goal of the LURN is to better characterize patients with LUTD in order to advance future research on the pathophysiology of these

Study Type

Observational

Enrollment (Actual)

1879

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Durham, North Carolina, United States, 27715
        • Duke University
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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).

Description

Inclusion Criteria:

  1. Men and women presenting for new patient visits for evaluation or treatment of LUTS to one of the LURN physicians.
  2. Age ≥ 18 years.
  3. The presence of any of the symptoms reported in Table 1, based on responses to the LUTS Tool with a one month recall period.
  4. The ability to give informed consent and complete self-reported questionnaires electronically.

Table 1: LUTS Appropriate for Study Inclusion

  • 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
  • Paruesis (shy bladder syndrome)
  • Poor or absent sensation of urethra during void
  • Feeling of incomplete emptying
  • Post-micturition dribble (delayed)
  • Abnormal bladder or urethral sensations

Exclusion Criteria:

  1. Gross hematuria.
  2. 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.
  3. Primary complaint is pelvic pain.
  4. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchialgia.
  5. Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
  6. Current sexually transmitted infection. (deferral; subject can enroll after negative culture)
  7. Ongoing symptomatic urethral stricture.
  8. History of lower urinary tract or pelvic malignancy.
  9. Current chemotherapy or other cancer therapy.
  10. Pelvic device or implant complication (e.g., sling or mesh complications).
  11. Current functioning neurostimulator.
  12. Botox injection to the bladder or pelvic structures within the preceding 12 months.
  13. In men, prostate biopsy in the previous 3 months.
  14. In women, pregnancy.
  15. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
  16. Augmentation cystoplasty or cystectomy.
  17. Presence of urinary tract fistula.
  18. Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.).
  19. Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
  20. Difficulty reading or communicating in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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.
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.

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.
Controls

Men and women who are not experiencing lower urinary tract symptoms.

This group will undergo MRI, pain and auditory sensitivity testing.

One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Other Names:
  • MRI
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.
Other Names:
  • Pain Sensitivity
Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.
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.

One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
Other Names:
  • MRI
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.
Other Names:
  • Pain Sensitivity
Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically relevant subgroups of patients with lower urinary tract symptoms
Time Frame: Baseline
Identification of patient clusters based on their symptoms, clinical assessments, and/or other characteristics.
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in lower urinary tract symptoms
Time Frame: baseline, 3 months, and 12 months
baseline, 3 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kevin P Weinfurt, PhD, Duke University
  • Study Chair: Claire Yang, MD, University of Washington
  • Principal Investigator: Robert M Merion, MD, FACS, Arbor Research Collaborative for Health - DCC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • LURN Phenotyping Study V8.0
  • U01DK100017 (U.S. NIH Grant/Contract)
  • U01DK100011 (U.S. NIH Grant/Contract)
  • U01DK099932 (U.S. NIH Grant/Contract)
  • U01DK099879 (U.S. NIH Grant/Contract)
  • U01DK097780 (U.S. NIH Grant/Contract)
  • U01DK097779 (U.S. NIH Grant/Contract)
  • U01DK097776 (U.S. NIH Grant/Contract)
  • U01DK097772 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not plan to make IPD available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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