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Completed

NCT Number: NCT06170450

Cyclic Versus Continuous Sacral Neuromodulation for LUTS

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville, Louisville, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclic SNM

Device

SNM cycling: 8 hours on, 16 hours off

Continuous SNM

Device

Continuous SNM: on continuously, no 'off' period

Primary outcomes

  1. Change in ICIQ-OAB-QoL Score

    Time frame: Baseline to 12 months post-operatively

    ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder. Score ranges 25-160 points with greater value indicating increased impact on quality of life.

Secondary outcomes

  1. Change in ICIQ-OAB-QoL Score

    Time frame: 1 month, 6 months post-operatively

    ICIQ-OABqol is a 28 question patient-completed survey evaluating quality of life (QoL) in patients with overactive bladder. Score ranges 25-160 points with greater value indicating increased impact on quality of life

  2. Change in OAB-q SF

    Time frame: 1 month, 6 months, 12 months post-operatively

    OAB-q SF is a 19 question patient-completed survey evaluating symptom bother and quality of life in patients with overactive bladder. Scores range 3- 36, higher values indicating increased symptom severity

  3. Change in Overactive Bladder Symptom Score (OABSS)

    Time frame: 1 month, 6 months, 12 months post-operatively

    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. Scores range 0-15 with higher scores indicating higher severity.

  4. Change in Incontinence Impact Questionnaire SF (IIQ-7)

    Time frame: 1 month, 6 months, 12 months post-operatively

    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. Scores range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher bother

  5. Urinary Distress Inventory SF (UDI-6)

    Time frame: 1 month, 6 months, 12 months post-operatively

    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. Scores 6 items, range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher distress.

  6. Patient Global Impression of Severity (PGI-S)

    Time frame: 1 month, 6 months, 12 months post-operatively

    Patient Global Impression of Severity (PGI-S) is a 1-item 4-point scale designed to assess for disease severity where 1 indicates "normal," 2 is "mild," 3 is "moderate," and 4 is "severe." Outcome measured is number of participants per group who reported disease is "severe" at each timepoint.

  7. Patient Global Impression of Improvement (PGI-I)

    Time frame: 1 month, 6 months, 12 months post-operatively

    Patient Global Impression of Improvement (PGI-I) is a 1-item scale designed to assess symptom improvement with answer choices: Very much better, Much better, A little better, No change, A little worse, Much worse, Very much worse. Outcome measure includes number of participants per group who reported "very much better" or "much better" at each timepoint

  8. Overactive Bladder Satisfaction of Treatment Questionnaire

    Time frame: 1 month, 6 months, 12 months post-operatively

    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. Score range 0-100 with higher scores indicating greater treatment satisfaction

  9. Change in Voiding Episodes Per Day

    Time frame: 1 month, 6 months, 12 months post-operatively

    Patients will use 3 days bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes per day. Daily voiding frequency will be the voiding episodes per day averaged over 3 day bladder diary.

  10. Change in Voiding Episodes Per Night

    Time frame: 1 month, 6 months, 12 months post-operatively

    Patients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes. Voiding episodes per night will be voiding episodes per night averaged over 3 day bladder diary.

  11. Change in Pads Per Day

    Time frame: 1 month, 6 months, 12 months post-operatively

    Patients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pads per day, and urge incontinence episodes. Pads per day will be the pad count per day averaged over 3 day bladder diary.

  12. Change in Urge Incontinence Episodes Per Day

    Time frame: 1 month, 6 months, 12 months post-operatively

    Patients will use 3 day bladder diaries to track voiding episodes per day, voiding episodes per night, pad count per day, and urge incontinence episodes per day. Urge incontinence episodes will be the urge incontinence episodes per day averaged over 3 day bladder diary.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Metro Health, Michigan
  • Northwestern University
  • University of Louisville

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 14, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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