An integrated behavioral treatment for improving nocturia and insomnia symptoms in older adults (MINT): study protocol for a multi-site randomized clinical trial.
This paper describes the protocol for a multicenter parallel-group randomized efficacy trial (MINT) comparing a 5-week integrated behavioral treatment program combining CBT-I and pelvic floor muscle exercise-based behavioral therapy to a health education control in older adults with both nocturia and insomnia symptoms.
Key Findings
Background
Nocturia of two or more times per night affects nearly one-third of older adults and can severely impact sleep, contributing to insomnia symptoms.
Nocturia is defined as waking to void during the primary sleep period two or more times per night.
The prevalence is described as affecting 'nearly one-third of older adults.'
Current treatment approaches for nocturia 'often overlook non-lower urinary tract factors that may contribute to nighttime awakenings.'
Because nocturia treatment crosses specialties, coordinated delivery of urological and sleep therapies is identified as a treatment barrier.
Methods
The MINT trial is designed as a multicenter parallel-group randomized efficacy trial comparing an integrated behavioral treatment to a health education control program.
The trial is registered at ClinicalTrials.gov as NCT06110091, registered 10/25/2023.
Recruitment sites are located in Atlanta and Los Angeles.
The proposed sample size is n = 192 participants.
Participants must be aged 60 years or older.
The trial employs a parallel-group design with randomization.
Methods
Eligible participants must report nocturia of two or more times per night and clinically significant insomnia symptoms.
Nocturia frequency is measured using the International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) nocturia item.
Insomnia symptoms are screened using an Insomnia Severity Index (ISI) score greater than 7.
Both urological and sleep criteria must be met for enrollment, reflecting the dual-condition focus of the trial.
Methods
The integrated behavioral treatment program is 5 weeks in duration and delivered by a single interventionist who may be a psychologist, nurse practitioner, or physician assistant.
The integrated program includes components of cognitive behavioral therapy for insomnia (CBT-I) and pelvic floor muscle exercise-based behavioral therapy for nocturia.
Delivery by a single interventionist is intended to address the barrier of coordinating care across specialties.
The program is described as non-pharmacological and non-surgical.
Early evidence cited in the abstract suggests CBT-I 'reduces nocturia and the bother it causes.'
Methods
The primary outcome of the trial is ICIQ-OAB-measured nocturia frequency assessed 4 months after randomization.
The primary outcome timepoint is 4 months post-randomization.
Nocturia frequency is measured using the ICIQ-OAB nocturia item.
Secondary outcomes include sleep diary-measured wake after sleep onset (mean minutes) and Insomnia Severity Index total score.
Conclusions
The trial aims to provide rigorous evidence that an integrated behavioral treatment can simultaneously reduce nocturia frequency and sleep disturbance in older adults.
The overall purpose is 'to determine whether a promising coordinated, integrated behavioral, non-pharmacological, non-surgical treatment that simultaneously addresses both the urological and insomnia factors contributing to nocturia is efficacious for improving nocturia, sleep, and daytime function.'
Outcomes include nocturia frequency, wake after sleep onset, and insomnia severity.
The interdisciplinary team designed the program to address nocturia 'in an efficient and safe manner.'
The protocol acknowledges that 'nocturia is a challenging symptom because it has many etiologies that cross multiple specialties.'
What This Means
This research describes the design of a clinical trial called MINT (Management of Insomnia and Nocturia Treatment) aimed at helping older adults who frequently wake up at night to urinate and also have trouble sleeping. About one-third of adults over 60 experience this problem, which is called nocturia, and it is often treated separately from sleep problems even though the two are closely linked. The trial will test whether a 5-week program that combines sleep therapy (cognitive behavioral therapy for insomnia, or CBT-I) with bladder and pelvic floor exercises — delivered by a single trained provider — works better than a general health education program. The study will enroll 192 adults aged 60 and older across sites in Atlanta and Los Angeles.
The main question the trial will answer is whether the integrated treatment reduces how often participants wake up to urinate at night, measured four months after the program ends. The researchers will also track improvements in sleep quality, including how long participants are awake during the night and overall insomnia severity. A key feature of the trial design is that one provider delivers the entire combined program, which is meant to overcome the typical challenge of patients needing to see multiple specialists for what are considered separate urological and sleep problems.
This research suggests that treating nocturia and insomnia together with a single coordinated behavioral approach — rather than managing them in separate medical specialties — could be a more effective and practical solution for older adults. If the integrated treatment proves efficacious, it could offer a non-drug, non-surgical option for a very common and disruptive condition that affects quality of life, safety (due to nighttime falls), and daytime functioning in older adults.
Fung C, Bolstad C, Huang A, Markland A, Cheng J, Alessi C, et al.. (2026). An integrated behavioral treatment for improving nocturia and insomnia symptoms in older adults (MINT): study protocol for a multi-site randomized clinical trial.. Trials. https://doi.org/10.1186/s13063-026-09464-2