Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
840 participants
OBSERVATIONAL
2021-02-17
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective Observational Cohort Study
Men and women with lower urinary tract symptoms.
Observational
Treatment:
Up to five interactions: In-person visits at Baseline, 3 months, and 12 months after initial visit, and phone/online interaction at 6 months and 9 months after initial visit.
Each in-person follow up visit is expected to last up to 2 hours and each phone/online interaction is expected to last up to 1½ hours.
Answering questions about your general health and urinary symptoms - may be done remotely Physical exam Completing Self- Reported Measures questionnaires - may be done remotely Completing voiding/intake and food diaries, either online or on paper Weekly text message survey regarding symptom and treatment changes
Biosample collection:
At baseline: Up to 4 tablespoons of whole blood, dried blood spots, and urine At baseline: Whole blood will be collected with other biospecimens At 3 months: Up to 4 tablespoons of blood, dried blood spots and urine At 12 months: Dried blood spots
Prospective Observational Cohort Study Controls
Men and women who do not have urinary dysfunction.
Observational Controls
One in-person visit that is expected to last up to 2 hours Answering questions about your general health and urinary history Physical exam Completing Self- Reported Measures questionnaires Completing voiding/intake and food diaries, either online or on paper Biosample collection of up to 4 tablespoons of whole blood, dried blood spots, and urine
Central Sensitization Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Central Sensitization
One in-person visit expected to take up to 30 minutes, that include:
Segmental Mechanical Hyperalgesia - a hand-held device with a small flat rubber surface will be placed above the pubic bone and forearm, and will apply pressure. Participant will be asked about the intensity and unpleasantness that they experience.
Pinprick Temporal Summation - participant will receive tactile stimulation by a pointed skin probe ("pinprick stimulator") being placed above the pubic bone and forearm. Participant will be asked to rate the sensation they are feeling.
Current treatment information including prior surgery or procedures, medication use, other current treatment/therapy used at the time of the visit.
Self-reported measures questionnaires
Central Sensitization Study Controls
Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Central Sensitization
One in-person visit expected to take up to 30 minutes, that include:
Segmental Mechanical Hyperalgesia - a hand-held device with a small flat rubber surface will be placed above the pubic bone and forearm, and will apply pressure. Participant will be asked about the intensity and unpleasantness that they experience.
Pinprick Temporal Summation - participant will receive tactile stimulation by a pointed skin probe ("pinprick stimulator") being placed above the pubic bone and forearm. Participant will be asked to rate the sensation they are feeling.
Current treatment information including prior surgery or procedures, medication use, other current treatment/therapy used at the time of the visit.
Self-reported measures questionnaires
Physical Activity and Sleep Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Physical Activity and Sleep Tracker
A physical activity and sleep monitor (Fitbit Charge 3 or similar) will be worn for a 2 week period starting at baseline prior to treatment and again at 3 months. During each 2 week period:
The Fitbit will be worn both day and night to collect the most information. Text message reminders to wear the Fitbit will be sent. Daily text messages asking the number of nighttime voids you had.
Physical Activity and Sleep Study Controls
Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Physical Activity and Sleep Tracker Controls
A physical activity and sleep monitor (Fitbit Charge 3 or similar) will be worn for a 2 week period at baseline prior to treatment. During the 2 week period:
The Fitbit will be worn both day and night to collect the most information. Text message reminders to wear the Fitbit will be sent. Daily text messages asking the number of nighttime voids you had.
Organ-Based Study
Women enrolled in the Prospective Observational Cohort Study with urinary urgency, with and without urgency incontinence.
Organ-Based
One in-person visit involving:
Urethral vibratory sensation threshold Urethral Pressure Profilometry Cystometry Uroflowmetry Lidocaine Pre-Treatment Cystometry
Organ-Based Study Controls
Women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence.
Organ-Based
One in-person visit involving:
Urethral vibratory sensation threshold Urethral Pressure Profilometry Cystometry Uroflowmetry Lidocaine Pre-Treatment Cystometry
Qualitative Assessment of Patients with Urinary Urgency Study
Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency who have treatment plans prescribed at the baseline visit.
Qualitative Assessment of Patients with Urinary Urgency
Participation will include two interviews with a research assistant over the phone and are expected to take up to 60 minutes for each interview. The first interview will be done within four weeks from enrollment, before the start of treatment. The interview will include questions about participant's urinary urgency, including symptoms experienced, the onset of symptoms and other factors that affect urgency.
Approximately three months after the start treatment the participant will be interviewed again. This interview will cover changes in symptoms and experience with treatment, such as side effects and satisfaction with treatment.
Interventions
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Observational
Treatment:
Up to five interactions: In-person visits at Baseline, 3 months, and 12 months after initial visit, and phone/online interaction at 6 months and 9 months after initial visit.
Each in-person follow up visit is expected to last up to 2 hours and each phone/online interaction is expected to last up to 1½ hours.
Answering questions about your general health and urinary symptoms - may be done remotely Physical exam Completing Self- Reported Measures questionnaires - may be done remotely Completing voiding/intake and food diaries, either online or on paper Weekly text message survey regarding symptom and treatment changes
Biosample collection:
At baseline: Up to 4 tablespoons of whole blood, dried blood spots, and urine At baseline: Whole blood will be collected with other biospecimens At 3 months: Up to 4 tablespoons of blood, dried blood spots and urine At 12 months: Dried blood spots
Observational Controls
One in-person visit that is expected to last up to 2 hours Answering questions about your general health and urinary history Physical exam Completing Self- Reported Measures questionnaires Completing voiding/intake and food diaries, either online or on paper Biosample collection of up to 4 tablespoons of whole blood, dried blood spots, and urine
Central Sensitization
One in-person visit expected to take up to 30 minutes, that include:
Segmental Mechanical Hyperalgesia - a hand-held device with a small flat rubber surface will be placed above the pubic bone and forearm, and will apply pressure. Participant will be asked about the intensity and unpleasantness that they experience.
Pinprick Temporal Summation - participant will receive tactile stimulation by a pointed skin probe ("pinprick stimulator") being placed above the pubic bone and forearm. Participant will be asked to rate the sensation they are feeling.
Current treatment information including prior surgery or procedures, medication use, other current treatment/therapy used at the time of the visit.
Self-reported measures questionnaires
Physical Activity and Sleep Tracker
A physical activity and sleep monitor (Fitbit Charge 3 or similar) will be worn for a 2 week period starting at baseline prior to treatment and again at 3 months. During each 2 week period:
The Fitbit will be worn both day and night to collect the most information. Text message reminders to wear the Fitbit will be sent. Daily text messages asking the number of nighttime voids you had.
Physical Activity and Sleep Tracker Controls
A physical activity and sleep monitor (Fitbit Charge 3 or similar) will be worn for a 2 week period at baseline prior to treatment. During the 2 week period:
The Fitbit will be worn both day and night to collect the most information. Text message reminders to wear the Fitbit will be sent. Daily text messages asking the number of nighttime voids you had.
Organ-Based
One in-person visit involving:
Urethral vibratory sensation threshold Urethral Pressure Profilometry Cystometry Uroflowmetry Lidocaine Pre-Treatment Cystometry
Qualitative Assessment of Patients with Urinary Urgency
Participation will include two interviews with a research assistant over the phone and are expected to take up to 60 minutes for each interview. The first interview will be done within four weeks from enrollment, before the start of treatment. The interview will include questions about participant's urinary urgency, including symptoms experienced, the onset of symptoms and other factors that affect urgency.
Approximately three months after the start treatment the participant will be interviewed again. This interview will cover changes in symptoms and experience with treatment, such as side effects and satisfaction with treatment.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* The presence of any of the urinary urgency or urgency incontinence symptoms based on responses to the LUTS Tool with a 1-month recall period (Appendix A) as follows:
Answered "sometimes", "often", or "always" on either:
* "During the past month, how often have you had a sudden need to rush to urinate?". Participants who answered "never" or "rarely" are not eligible since they are not deemed to have significant urinary urgency symptoms.
* "How often have you had a sudden need to rush to urinate for the fear of leaking urine?"
* Positive answer must also be associated with bother rating on that particular question of "somewhat", "quite a bit", or "a great deal"
* The ability to give informed consent and complete self-reported questionnaires electronically.
* Access to and willingness to utilize smart phone
Exclusion Criteria
b. Gross hematuria/self-reported gross or visible urine in the blood. c. 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.
d. Primary complaint is pelvic pain. e. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchalgia.
f. Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
g. Ongoing symptomatic urethral stricture. h. History of LUT or pelvic malignancy. i. Current chemotherapy or other cancer therapy. j. Pelvic device or implant complication (e.g., sling or mesh complications). k. In men, prostate biopsy in the previous 6 months. l. In women, current pregnancy or planned pregnancy during the follow-up period.
m. History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.
n. Augmentation cystoplasty or cystectomy. o. Presence of urinary tract fistula. p. Current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g., dementia, psychosis, etc.).
q. Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
r. Difficulty reading or communicating in English. s. No access to internet/smart phone. t. Indwelling Foley catheter/routine self-catheterization. u. In addition to the criteria listed above, pregnancy during the study will be a study end point.
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Michigan
OTHER
Northwestern University
OTHER
Duke University
OTHER
University of Iowa
OTHER
University of Washington
OTHER
Washington University School of Medicine
OTHER
Arbor Research Collaborative for Health
OTHER
Responsible Party
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Principal Investigators
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Henry Lai, MD
Role: STUDY_CHAIR
Washington University School of Medicine
John Graff, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
Arbor Research Collaborative for Health - DCC
Locations
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Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Cameron AP, Lewicky-Gaupp C, Smith AR, Helfand BT, Gore JL, Clemens JQ, Yang CC, Siddiqui NY, Lai HH, Griffith JW, Andreev VP, Liu G, Weinfurt K, Amundsen CL, Bradley CS, Kusek JW, Kirkali Z; Symptoms of Lower Urinary Tract Dysfunction Research Network Study Group. Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study. J Urol. 2018 Apr;199(4):1023-1031. doi: 10.1016/j.juro.2017.10.035. Epub 2017 Oct 28.
Weinfurt KP, Griffith JW, Flynn KE, Cella D, Bavendam T, Wiseman JB, Andreev VP, Lai HH, Liu AB, Kirkali Z, Cameron AP, Bradley CS; LURN Study Group. The Comprehensive Assessment of Self-Reported Urinary Symptoms: A New Tool for Research on Subtypes of Patients with Lower Urinary Tract Symptoms. J Urol. 2019 Jun;201(6):1177-1183. doi: 10.1097/JU.0000000000000140.
Andreev VP, Liu G, Yang CC, Smith AR, Helmuth ME, Wiseman JB, Merion RM, Weinfurt KP, Cameron AP, Lai HH, Cella D, Gillespie BW, Helfand BT, Griffith JW, DeLancey JOL, Fraser MO, Clemens JQ, Kirkali Z; LURN Study Group. Symptom Based Clustering of Women in the LURN Observational Cohort Study. J Urol. 2018 Dec;200(6):1323-1331. doi: 10.1016/j.juro.2018.06.068. Epub 2018 Jul 7.
Reynolds WS, Dmochowski R, Wein A, Bruehl S. Does central sensitization help explain idiopathic overactive bladder? Nat Rev Urol. 2016 Aug;13(8):481-91. doi: 10.1038/nrurol.2016.95. Epub 2016 Jun 1.
Ge TJ, Vetter J, Lai HH. Sleep Disturbance and Fatigue Are Associated With More Severe Urinary Incontinence and Overactive Bladder Symptoms. Urology. 2017 Nov;109:67-73. doi: 10.1016/j.urology.2017.07.039. Epub 2017 Aug 4.
Hokanson JA, DeLancey JOL, Kirby AC, Gillespie B, Lai HH, Kreder KJ, Bretschneider CE, Slavik N, Andrews C, Andreev V, Black L, Richardson S, Kenton K, Kirkali Z, Yang CC; Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Study Group. Expanded Physiological Testing of the Lower Urinary Tract in Asymptomatic Women and Those With Urgency Urinary Incontinence: Findings From the LURN-Organ Study. Neurourol Urodyn. 2025 Jun;44(5):987-996. doi: 10.1002/nau.70038. Epub 2025 Mar 31.
Related Links
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Study website
Other Identifiers
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LURN 2
Identifier Type: -
Identifier Source: org_study_id
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