LURN: Urinary Urgency Phenotyping Protocol

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557748
• Other study ID #: LURN 2
• Secondary ID: U01DK099879U01DK
• Status: Recruiting
• Start date: February 17, 2021
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Arbor Research Collaborative for Health
• Contact: Melissa Sexton, BBA, CCRP
• Phone: 734.369.9635
• Email: melissa.sexton[@]arborresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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 symptoms of urinary urgency and urgency urinary incontinence.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Northwestern University	Chicago	Illinois
United States	Duke University	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Arbor Research Collaborative for Health	Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University, University of Iowa, University of Michigan, University of Washington, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline
Secondary	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	Baseline and 3 months
Secondary	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	Baseline

External Links

•   Study website