Lower Urinary Tract SymptomsNCT04557748

LURN: Urinary Urgency Phenotyping Protocol

An observational study of Lower Urinary Tract Symptoms, run by Arbor Research Collaborative for Health at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lower Urinary Tract Symptoms
What is being tested?: Observational, Central Sensitization and Physical Activity and Sleep Tracker
How many people: 1,030 participants
Where: 6 sitesUnited States
Study dates: 17 Feb 2021to 12 Aug 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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?"

Show all 9Show fewer

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

Who cannot join

a. Clinical impression of bladder outlet obstruction (based on symptoms or urodynamics) as primary etiology of LUTS.
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.
Primary complaint is pelvic pain. e. Diagnosis of interstitial cystitis, chronic prostatitis, or chronic orchalgia.
Pelvic or endoscopic GU surgery within the preceding 6 months (not including diagnostic cystoscopy).
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.
History of cystitis caused by tuberculosis, radiation therapy, or Cytoxan/cyclophosphamide therapy.

Show all 9Show fewer

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.).
Inability to relay valid information, actively participate in the study, or provide informed consent (includes uncontrolled psychiatric disease).
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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of Michigan
Ann Arbor, Michigan, 48109
Northwestern University
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27715
University of Iowa
Iowa City, Iowa, 52242
University of Washington
Seattle, Washington, 98195
Washington University in St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Urinary Urgency Phenotyping Protocol

Read the detailed description

LURN is pursuing deeper phenotyping of patients with urinary urgency and UUI using distinct, but related, projects. The Urinary Urgency Phenotyping Protocol is the overarching effort, and will comprise five integrated projects. Project A, the Observational Cohort, will be a large-scale accrual of male and female participants with urinary urgency and age-matched controls without any LUTS. Standardized clinical data, comprising information typically gathered at the patient clinic encounter, self-report symptom, urologic and non-urologic data, and biosamples will be collected. Using this group of participants, subsets will be identified for more focused and in-depth studies of urinary urgency and urgency incontinence. This more focused effort will be conducted as Project B: the Central Sensitization Study; Project C: the Physical Activity and Sleep Study; Project D: the Organ-Based Study; and Project E: the Qualitative Assessment of Patients with Urinary Urgency Study.

Conditions: Lower Urinary Tract Symptoms
Being tested: Observational, Observational Controls, Central Sensitization, Physical Activity and Sleep Tracker, Physical Activity and Sleep Tracker Controls
Keywords: Lower Urinary Tract Symptoms, Bladder Symptoms, Overactive Bladder, Urinary Urgency, Lower Urinary Tract Dysfunction
Medical subject headings: Lower Urinary Tract Symptoms, Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ObservationalOther
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 ControlsOther
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 SensitizationOther
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 TrackerOther
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 ControlsOther
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-BasedOther
One in-person visit involving:
Urethral vibratory sensation threshold Urethral Pressure Profilometry Cystometry Uroflowmetry Lidocaine Pre-Treatment Cystometry
Qualitative Assessment of Patients with Urinary UrgencyOther
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.

Study groups in NCT04557748
Study group	Role	What they receive
Prospective Observational Cohort Study		Men and women with lower urinary tract symptoms. Receives: Other: Observational
Prospective Observational Cohort Study Controls		Men and women who do not have urinary dysfunction. Receives: Other: Observational Controls
Central Sensitization Study		Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency. Receives: Other: Central Sensitization
Central Sensitization Study Controls		Men and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency. Receives: Other: Central Sensitization
Physical Activity and Sleep Study		Men and women enrolled in the Prospective Observational Cohort Study with urinary urgency. Receives: 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. Receives: 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. Receives: Other: Organ-Based
Organ-Based Study Controls		Women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence. Receives: 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. Receives: Other: Qualitative Assessment of Patients with Urinary Urgency

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Participants will rate pain intensity and unpleasantness on 0-100 numeric rating scales when ascending pressure is applied to the suprapubic area using a hand-held algometer
Measured: Baseline
Assess the relationship between physical activity and sleep quality in men and women with bothersome urinary urgency
Participants will wear a mobile tracker for two weeks at baseline and at 3 months to capture the average number of steps per 24 hours and number of nocturnal voids
Measured: Baseline and 3 months
The role of the urethra and its interaction with the bladder in LUT function and dysfunction
Urodynamic studies will be performed on urethra and bladder to assess urethral closure pressure, urethral sensation, and bladder volume
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 202112 Aug 2025

First posted22 Sep 2020
Study start17 Feb 2021
Primary completion12 Aug 2025
Study completion12 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,030 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04557748
Sponsor's protocol ID: LURN 2
Other IDs: U01DK099879, U01DK097780, U01DK097772, U01DK097779, U01DK099932, U01DK100011, U01DK100017
Status last verified: Jul 2026
First submitted: 8 Sep 2020
Last updated: 24 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We do not plan to make IPD available.

Publications

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.
PubMed 29111381
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.
PubMed 30730410
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.
PubMed 29990467
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.
PubMed 27245505
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.
PubMed 28826875
Lai HH; LURN Study Group. The LURN Study-What Have We "LURN"ed So Far? Neurourol Urodyn. 2026 Apr;45(4):654-661. doi: 10.1002/nau.70224.
PubMed 41944009
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.
PubMed 40159923

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
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All Lower Urinary Tract Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Urinary Urgency Phenotyping Protocol
ClinicalTrials.gov ID: NCT04557748
Acronym / sponsor ID: LURN 2
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower Urinary Tract Symptoms, Bladder Symptoms, Overactive Bladder, Urinary Urgency, Lower Urinary Tract Dysfunction
Study type: Observational
Recruitment status: Completed
Enrolment: 1,030 participants (actual)
Lead sponsor: Arbor Research Collaborative for HealthUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Michigan, Northwestern University, Duke University, University of Iowa, University of Washington, Washington University School of Medicine
Study start: 17 Feb 2021 (actual)
Primary completion: 12 Aug 2025 (actual)
Study completion: 12 Aug 2025 (actual)
First posted: 22 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 9

Arm	Type	Receives
Prospective Observational Cohort Study	–	Other: ObservationalMen and women with lower urinary tract symptoms.
Prospective Observational Cohort Study Controls	–	Other: Observational ControlsMen and women who do not have urinary dysfunction.
Central Sensitization Study	–	Other: Central SensitizationMen and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Central Sensitization Study Controls	–	Other: Central SensitizationMen and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Physical Activity and Sleep Study	–	Other: Physical Activity and Sleep TrackerMen and women enrolled in the Prospective Observational Cohort Study with urinary urgency.
Physical Activity and Sleep Study Controls	–	Other: Physical Activity and Sleep Tracker ControlsMen and women enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency.
Organ-Based Study	–	Other: Organ-BasedWomen enrolled in the Prospective Observational Cohort Study with urinary urgency, with and without urgency incontinence.
Organ-Based Study Controls	–	Other: Organ-BasedWomen enrolled in the Prospective Observational Cohort Study with no symptoms of urinary urgency pr urgency incontinence.
Qualitative Assessment of Patients with Urinary Urgency Study	–	Other: Qualitative Assessment of Patients with Urinary UrgencyMen and women enrolled in the Prospective Observational Cohort Study with urinary urgency who have treatment plans prescribed at the baseline visit.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (9 listed)

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:
"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?"

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ObservationalTreatment: 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	Other	Prospective Observational Cohort Study
Observational ControlsOne 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	Other	Prospective Observational Cohort Study Controls
Central SensitizationOne 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	Other	Central Sensitization Study, Central Sensitization Study Controls
Physical Activity and Sleep TrackerA 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.	Other	Physical Activity and Sleep Study
Physical Activity and Sleep Tracker ControlsA 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.	Other	Physical Activity and Sleep Study Controls
Organ-BasedOne in-person visit involving: Urethral vibratory sensation threshold Urethral Pressure Profilometry Cystometry Uroflowmetry Lidocaine Pre-Treatment Cystometry	Other	Organ-Based Study, Organ-Based Study Controls
Qualitative Assessment of Patients with Urinary UrgencyParticipation 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.	Other	Qualitative Assessment of Patients with Urinary Urgency Study

Primary outcome

Change in lower urinary tract symptoms
Time frame: Baseline, 3 months, 6 month, 9 months,12 months
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

3 secondary outcomes

Examine the presence of sensory hypersensitivity in urinary urgency (with or without urgency incontinence)
Time frame: Baseline
Assess the relationship between physical activity and sleep quality in men and women with bothersome urinary urgency
Time frame: Baseline and 3 months
The role of the urethra and its interaction with the bladder in LUT function and dysfunction
Time frame: Baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
Background: PubMed 29111381Cameron 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.
Background: PubMed 30730410Weinfurt 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.
Background: PubMed 29990467Andreev 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.
Background: PubMed 27245505Reynolds 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.
Background: PubMed 28826875Ge 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.
Derived from this study: PubMed 41944009Lai HH; LURN Study Group. The LURN Study-What Have We "LURN"ed So Far? Neurourol Urodyn. 2026 Apr;45(4):654-661. doi: 10.1002/nau.70224.
Derived from this study: PubMed 40159923Hokanson 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.
Study websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. We do not plan to make IPD available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Henry Lai, MD study chair

Washington University School of Medicine

John Graff, PhD, MS principal investigator

Arbor Research Collaborative for Health - DCC

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Urinary Tract Symptoms, run by Arbor Research Collaborative for Health at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lower urinary tract symptoms (time frame: Baseline, 3 months, 6 month, 9 months,12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04557748, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.