Cyclic Versus Continuous Sacral Neuromodulation for LUTS

Overactive Bladder Syndrome Clinical Trial

Official title:

CYclic Versus Continuous Sacral Modulation for LowEr Urinary Tract Symptoms: a Prospective Randomized Controlled Trial (CYCLE Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170450
• Other study ID #: STUDY20231521
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: June 2030

Study information

• Verified date: May 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Margot Le Neveu, MD
• Phone: 2168443722
• Email: Margot.LeNeveu[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2030
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Device:
• Cyclic SNM
SNM cycling: 8 hours on, 16 hours off
• Continuous SNM
Continuous SNM: on continuously, no 'off' period

Locations

Country	Name	City	State
United States	MetroHealth	Cleveland	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	University of Louisville	Louisville	Kentucky

Sponsors (4)

Lead Sponsor	Collaborator
David Sheyn	Metro Health, Michigan, Northwestern University, University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ICIQ-OAB-QoL score	ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.	Baseline, 12 months post-operatively
Secondary	Change in ICIQ-OAB-QoL score	ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Change in OAB-q SF	OAB-q SF is a 19 question patient-completed survey evaluating symptom bother and quality of life in patients with overactive bladder.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Change in Overactive Bladder Symptom Score (OABSS)	The Overactive Bladder Symptom Score (OABSS) is a 4 question validated symptom assessment tool for patients with OAB and assesses number of episodes of frequency, nocturia, urgency, and urge incontinence.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Change in Incontinence Impact Questionnaire SF (IIQ-7)	Incontinence Impact Questionnaire SF (IIQ-7) is a 7-item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Urinary Distress Inventory SF (UDI-6)	Urinary Distress Inventory SF (UDI-6) is a 6 item validated questionnaire that assesses urinary symptoms, the symptom bother, and the impact the bother has on patients' quality of life using a 4-point bother scale.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Patient Global Impression of Severity (PGI-S)	Patient Global Impression of Severity (PGI-S) is a 1-item scale designed to assess for disease severity.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Patient Global Impression of Improvement (PGI-I)	Patient Global Impression of Improvement (PGI-I) is a 1-item scale designed to assess symptom improvement.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Overactive Bladder Satisfaction of Treatment Questionnaire	Change in Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SAT-q) is an 11-item validated questionnaire that assesses patients' satisfaction with their OAB treatment within a clinical setting from baseline.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Change in voiding frequency (# of voiding episodes in 24 hours)	Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Daily voiding frequency will be the average # of voids per 24h averaged over 3 day bladder diary.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Change in nocturia episodes	Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Nocturia episodes will be the average # of voids overnight per day averaged over 3 day bladder diary.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Change in urgency episodes	Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Urgency episodes will be the average # of urgency episodes per 24h averaged over 3 day bladder diary.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively
Secondary	Change in urinary urge incontinence episodes	Patients will use 3 days bladder diaries to track # of voids during the day, # of voids during the night, urgency episodes, and urge incontinence episodes. Urinary urge incontinence episodes will be the average # of urinary urge incontinence episodes per 24h averaged over 3 day bladder diary.	Baseline, 1 month, 6 months, 12 months, 3 years, 5 years post-operatively