LURN: Urinary Urgency Phenotyping Protocol

NCT04557748 | Active Not Recruiting DMC

• 8 other identifiers: LURN 2U01DK099879U01DK097780U01DK097772U01DK097779U01DK099932U01DK100011U01DK100017
• Study Type: observational
• Target: 840
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to define and characterize important subtypes of patients with urinary urgency to improve our understanding of the pathophysiology, risk factors, experiences, and comorbidities to lay the foundation for more effective treatment by focusing on the most bothersome and difficult to treat symptoms of urinary urgency and urgency urinary incontinence.

Conditions

Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract Symptoms; Bladder Symptoms; Overactive Bladder; Urinary Urgency; Lower Urinary Tract Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in lower urinary tract symptoms

  Participants will be classified as treatment responders if they achieve at least a 10-point reduction from baseline on the OAB-q and/or respond "much better" or "very much better" on the PGI-I

  Baseline, 3 months, 6 month, 9 months,12 months

Secondary Outcomes (3)

• Examine the presence of sensory hypersensitivity in urinary urgency (with or without urgency incontinence)

  Baseline

• Assess the relationship between physical activity and sleep quality in men and women with bothersome urinary urgency

  Baseline and 3 months

• The role of the urethra and its interaction with the bladder in LUT function and dysfunction

  Baseline

Study Arms (9)

Prospective Observational Cohort Study

Men and women with lower urinary tract symptoms.

Other: Observational

Prospective Observational Cohort Study Controls

Men and women who do not have urinary dysfunction.

Other: Observational Controls

Central Sensitization Study

Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.

Other: Central Sensitization

Central Sensitization Study Controls

Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.

Other: Central Sensitization

Physical Activity and Sleep Study

Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency.

Other: Physical Activity and Sleep Tracker

Physical Activity and Sleep Study Controls

Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.

Other: Physical Activity and Sleep Tracker Controls

Organ-Based Study

Women enrolled in the Prospective Observational Cohort Study with urinary urgency, with and without urgency incontinence.

Other: Organ-Based

Organ-Based Study Controls

Women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence.

Other: Organ-Based

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.

Other: Qualitative Assessment of Patients with Urinary Urgency

Interventions

Physical Activity and Sleep Tracker OTHER

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

Physical Activity and Sleep Tracker Controls OTHER

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.

Physical Activity and Sleep Study Controls

Organ-Based OTHER

One in-person visit involving: Urethral vibratory sensation threshold Urethral Pressure Profilometry Cystometry Uroflowmetry Lidocaine Pre-Treatment Cystometry

Organ-Based Study; Organ-Based Study Controls

Qualitative Assessment of Patients with Urinary Urgency OTHER

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.

Qualitative Assessment of Patients with Urinary Urgency Study

Observational OTHER

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

Observational Controls OTHER

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

Prospective Observational Cohort Study Controls

Central Sensitization OTHER

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; Central Sensitization Study Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women with urinary urgency an/or urgency incontinence who are treatment-naïve patients, patients undergoing current treatment, and those who have failed therapies for lower urinary tract symptoms.

You may qualify if:

• Women or men presenting for evaluation or treatment of urinary urgency/ UUI to one of the LURN sites. These symptoms are not required to be the primary symptom(s) of presentation, but must be bothersome to the participant.
• 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

You may not qualify if:

• a. Clinical impression of bladder outlet obstruction (based on symptoms or urodynamics) as primary etiology of LUTS.
• 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.

Sponsors & Collaborators

• University of Michigan: collaborator
• Northwestern University: collaborator
• Duke University: collaborator
• University of Iowa: collaborator
• University of Washington: collaborator
• Washington University School of Medicine: collaborator
• Arbor Research Collaborative for Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

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 in St. Louis

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 (6)

• 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.

  PMID: 29111381 BACKGROUND

• 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.

  PMID: 30730410 BACKGROUND

• 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.

  PMID: 29990467 BACKGROUND

• 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.

  PMID: 27245505 BACKGROUND

• 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.

  PMID: 28826875 BACKGROUND

• 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.

  PMID: 40159923 DERIVED

Related Links

• Study website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood Serum Plasma Urine Dried blood spots

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Overactive

Interventions

Watchful Waiting; Central Nervous System Sensitization; Exercise

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena

Study Officials

• Henry Lai, MD

  Washington University School of Medicine

  STUDY CHAIR

• John Graff, PhD, MS

  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: September 8, 2020
• First Posted: September 22, 2020
• Study Start: February 17, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)