Clinical trial NCT06170450: Cyclic Versus Continuous Sacral Neuromodulation for LUTS
Official title: CYclic Versus Continuous Sacral Modulation for LowEr Urinary Tract Symptoms: a Prospective Randomized Controlled Trial (CYCLE Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overactive Bladder Syndrome
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: University of Louisville
name: Metro Health, Michigan
First posted: 2023-12-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.

Detailed description: Overactive bladder (OAB) is characterized by urinary frequency, urgency, incontinence, and nocturia in the absence of other pathology. AUA guidelines recommend trial of sacral neuromodulation (SNM) for patients with refractory OAB who have failed treatment with behavioral modification and medication. SNM settings are typically selected based on discussion between the patient and device representative. There is a paucity of rigorous data assessing optimal SNM stimulation programming for symptomatic improvement.

This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) in patients undergoing SNM for OAB.

Patients \> age 18 with a diagnosis of refractory OAB being scheduled for a trial of SNM (either stage I lead/temporary battery placement or office peripheral nerve evaluation) will be approached by study personnel during their clinic visit or by a phone call to determine if they are interested in participating in the programming study.

Patients interested in participating will provide written informed consent. After informed consent is obtained, a baseline evaluation will be performed. This includes history, 3-day voiding diary (# voiding episodes, # nocturia episodes, # urge incontinence episodes/24h), urinalysis, urine culture (if indicated), post void residuals, and symptom assessments using questionnaires.

Only those with successful trial and eligible/ interested in permanent SNM placement will participate in this trial. Randomization will occur after stage 2/ full permanent implantation when the neuromodulator is being programmed in the recovery room. Patients will be randomly assigned to either continuous stimulation or cyclic stimulation.

Patients will then be followed with clinical evaluation and questionnaires repeated at 1 month, 6 months, 12 months, 3 years, and 5 years post-op.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Female
* English Speaking
* Diagnosis of urinary urge incontinence or overactive bladder
* Meet criteria for and are planning permanent SNM (ie. successful stage I or office PNE trial of SNM with 50% or more reduction in UUI episodes)
* Willing and able to complete all study related items

Exclusion Criteria:

* Patients less than 18 years of age
* Unable to provide consent
* Non-English speaking
* Relevant neurologic diseases (multiple sclerosis, Parkinson Disease, myasthenia gravis, - - - Charcot-Marie-Tooth disease, complete spinal cord injury)
* Current or prior bladder malignancy

Primary outcomes:
measure: Change in ICIQ-OAB-QoL score
timeFrame: Baseline, 12 months post-operatively
Secondary outcomes:
measure: Change in ICIQ-OAB-QoL score
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Change in OAB-q SF
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Change in Overactive Bladder Symptom Score (OABSS)
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Change in Incontinence Impact Questionnaire SF (IIQ-7)
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Urinary Distress Inventory SF (UDI-6)
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Overactive Bladder Satisfaction of Treatment Questionnaire
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Change in voiding frequency (# of voiding episodes in 24 hours)
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Change in nocturia episodes
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Change in urgency episodes
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
measure: Change in urinary urge incontinence episodes
timeFrame: Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
Study officials:
affiliation: UH Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References: