RECRUITING

Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Urgency urinary incontinence (UUI) is common in older people and vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will investigate the role of adding behavioral sleep intervention to the standard pharmacotherapy in treatment of UUI among older adults, and the brain mechanisms involved in continence by evaluating brain changes. This will expand the current knowledge of how the sleep affects bladder control, and better characterize the brain mechanisms in maintaining continence.

Official Title

Effect of Behavioral Sleep Intervention on Lower Urinary Tract Symptoms in Older Women

Quick Facts

Study Start:2023-03-05

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05604222

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.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ambulatory women aged 60+ years * urgency incontinence or urge-predominant mixed incontinence (able to differentiate between stress symptoms-cough, laugh, exercise-and leakage following the sudden onset of a strong urge to void that is difficult to defer during questioning on telephone screening) occurring at least five times weekly for ≥ 3 months despite treatment for reversible causes * nocturia ≥2 each night * subjects with current or previous use of anticholinergic medications will be considered for the study if willing to go through a washout period of at least 4 weeks of duration	* contraindication to any of the drugs used (e.g., mirabegron, prophylactic antibiotics) * cognitive impairment (MOCA score \<24 or inability to accurately complete a voiding diary, perform a 24-hour pad test, reliably take daily medication, or comply with fMRI testing) * prior treatment with intradetrusor onabotulinum toxin or sacral neuromodulation. * spinal cord injury; history of pelvic irradiation, advanced uterine or bladder cancer; multiple sclerosis * urethral obstruction; urinary retention \[PVR \>200 ml\] * interstitial cystitis; artificial sphincter implant * medical instability or expected change in medication during the study * conditions that preclude fMRI testing, such as history of claustrophobia, history or suspicion of implanted metal or electronic object * requirement for intravenous antibiotics for bacterial endocarditis prophylaxis or presence of multiple allergies to the antibiotics available in our protocol * chronic or recurrent bowel issues, e.g. IBS, colitis, fecal incontinence * known allergy to study medication or interaction with current medications * severe uncontrolled hypertension \>180 mmHg systolic or \>100 mmHg diastolic

Inclusion Criteria

Exclusion Criteria

* ambulatory women aged 60+ years
* urgency incontinence or urge-predominant mixed incontinence (able to differentiate between stress symptoms-cough, laugh, exercise-and leakage following the sudden onset of a strong urge to void that is difficult to defer during questioning on telephone screening) occurring at least five times weekly for ≥ 3 months despite treatment for reversible causes
* nocturia ≥2 each night
* subjects with current or previous use of anticholinergic medications will be considered for the study if willing to go through a washout period of at least 4 weeks of duration

* contraindication to any of the drugs used (e.g., mirabegron, prophylactic antibiotics)
* cognitive impairment (MOCA score \<24 or inability to accurately complete a voiding diary, perform a 24-hour pad test, reliably take daily medication, or comply with fMRI testing)
* prior treatment with intradetrusor onabotulinum toxin or sacral neuromodulation.
* spinal cord injury; history of pelvic irradiation, advanced uterine or bladder cancer; multiple sclerosis
* urethral obstruction; urinary retention \[PVR \>200 ml\]
* interstitial cystitis; artificial sphincter implant
* medical instability or expected change in medication during the study
* conditions that preclude fMRI testing, such as history of claustrophobia, history or suspicion of implanted metal or electronic object
* requirement for intravenous antibiotics for bacterial endocarditis prophylaxis or presence of multiple allergies to the antibiotics available in our protocol
* chronic or recurrent bowel issues, e.g. IBS, colitis, fecal incontinence
* known allergy to study medication or interaction with current medications
* severe uncontrolled hypertension \>180 mmHg systolic or \>100 mmHg diastolic

Contacts and Locations

Study Contact

Shachi Tyagi, MD

CONTACT

412-647-1274

tyagis@upmc.edu

Principal Investigator

Shachi Tyagi, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Shachi Tyagi

Shachi Tyagi, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Registration Dates

Study Start Date2023-03-05

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-03-05

Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

Urgency Urinary Incontinence
Nocturia