An interventional study of Cyclic SNM and Continuous SNM in Overactive Bladder Syndrome, sponsored by University Hospitals Cleveland Medical Center. Completed at 3 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.
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.
University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.
Device: Cyclic SNM
Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)
Device: Continuous SNM
SNM cycling: 8 hours on, 16 hours off
Continuous SNM: on continuously, no 'off' period
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. Score ranges 25-160 points with greater value indicating increased impact on quality of life.
Time frame: Baseline to 12 months post-operatively
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. Score ranges 25-160 points with greater value indicating increased impact on quality of life
Time frame: 1 month, 6 months post-operatively
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. Scores range 3- 36, higher values indicating increased symptom severity
Time frame: 1 month, 6 months, 12 months post-operatively
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. Scores range 0-15 with higher scores indicating higher severity.
Time frame: 1 month, 6 months, 12 months post-operatively
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. Scores range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher bother
Time frame: 1 month, 6 months, 12 months post-operatively
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. Scores 6 items, range 0-100 (raw score multiplied by 33 1/3 to transform scale) with higher scores indicating higher distress.
Time frame: 1 month, 6 months, 12 months post-operatively
Patient Global Impression of Severity (PGI-S)
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.
Time frame: 1 month, 6 months, 12 months post-operatively
Patient Global Impression of Improvement (PGI-I)
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
Time frame: 1 month, 6 months, 12 months post-operatively
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. Score range 0-100 with higher scores indicating greater treatment satisfaction
Time frame: 1 month, 6 months, 12 months post-operatively
Change in Voiding Episodes Per Day
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.
Time frame: 1 month, 6 months, 12 months post-operatively
Change in Voiding Episodes Per Night
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.
Time frame: 1 month, 6 months, 12 months post-operatively
Change in Pads Per Day
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.
Time frame: 1 month, 6 months, 12 months post-operatively
Change in Urge Incontinence Episodes Per Day
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.
Time frame: 1 month, 6 months, 12 months post-operatively
| Milestone | Cyclic SNM | Continuous SNM |
|---|---|---|
| Started | 25 | 25 |
| Completed | 21 | 24 |
| Not completed | 4 | 1 |
| Withdrew: Lost to follow-up | 4 | 1 |
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.
| change in score on a scale | Cyclic SNM | Continuous SNM |
|---|---|---|
| Change in ICIQ-OAB-QoL Score | -29.4 ± 33 | -27.0 ± 36 |
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
| change in score on a scale | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -40.0 ± 30 | -45.7 ± 26 |
| 6 months post-operatively | -25.3 ± 34 | -44.0 ± 32 |
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
| Change in score on a scale | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -11.1 ± 6 | -12.2 ± 9 |
| 6 months post- operatively | -7.1 ± 9 | -11.9 ± 8 |
| 12 months post-operatively | -7.9 ± 7 | -8.0 ± 9 |
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.
| Change in score on a scale | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -3.7 ± 3 | -5.3 ± 4 |
| 6 months post-operatively | -1.9 ± 3 | -4.5 ± 4 |
| 12 months post-operatively | -2.6 ± 3 | -2.6 ± 4 |
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
| Change in score on a scale | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -39.9 ± 32 | -46.6 ± 31 |
| 6 months post-operatively | -25.9 ± 37 | -49.0 ± 31 |
| 12 months post-operatively | -25.7 ± 34 | -34.6 ± 39 |
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.
| Change in score on a scale | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -20.7 ± 21 | -36.2 ± 21 |
| 6 months post-operatively | -15.4 ± 29 | -34.6 ± 19 |
| 12 months post-operatively | -15.0 ± 20 | -25.5 ± 25 |
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.
| Participants | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | 1 | 0 |
| 6 months post-operativley | 5 | 4 |
| 12 months post-operatively | 5 | 3 |
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
| Participants | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | 9 | 14 |
| 6 months post-operatively | 7 | 14 |
| 12 months post-operatively | 11 | 14 |
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
| score on a scale | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | 73.5 ± 13 | 77.8 ± 22 |
| 6 months post-operatively | 67.3 ± 22 | 76.9 ± 20 |
| 12 months post-operatively | 68.3 ± 16 | 70.5 ± 13 |
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.
| Voiding episodes per day | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -3.2 (-4.1 to -2.3) | -3.3 (-4.2 to -2.3) |
| 6 months post-operatively | -2.2 (-3.3 to -1.1) | -3.1 (-4.2 to -2.0) |
| 12 months post-operatively | -2.5 (-3.9 to -1.2) | -2.4 (-3.7 to -1.1) |
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.
| Voiding episodes per night | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -0.9 (-1.4 to -0.3) | -0.9 (-1.4 to -0.3) |
| 6 months post-operatively | -0.02 (-0.7 to 0.7) | -1.1 (-1.8 to -0.4) |
| 12 months post-operatively | -0.1 (-1.0 to 0.8) | -0.3 (-1.1 to 0.6) |
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.
| Pads per day | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -1.8 (-2.7 to -0.9) | -2.4 (-3.3 to -1.6) |
| 6 months post-operatively | -0.1 (-1.2 to 0.9) | -1.9 (-2.9 to -0.9) |
| 12 months post-operatively | -0.6 (-1.9 to 0.7) | -1.3 (-2.6 to 0.02) |
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.
| Urge incontinence episodes per | Cyclic SNM | Continuous SNM |
|---|---|---|
| 1 month post-operatively | -3.1 (-4.1 to -2.0) | -4.5 (-5.7 to -3.4) |
| 6 months post-operatively | -1.8 (-2.9 to -0.6) | -3.4 (-4.5 to -2.2) |
| 12 months post-operatively | -2.7 (-4.2 to -1.2) | -1.9 (-3.4 to -0.5) |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cyclic SNM | 0/25 (0%) | 0/25 (0%) | 10/25 (40%) |
| Continuous SNM | 0/25 (0%) | 0/25 (0%) | 11/25 (44%) |
| Event | Cyclic SNM | Continuous SNM |
|---|---|---|
| Reported uncomfortable stimulationNervous system disorders | 8/25 | 10/25 |
| Surgical revision of device due to malpositioningSurgical and medical procedures | 2/25 | 1/25 |
| Device infectionInfections and infestations | 0/25 | 1/25 |
| Surgical removal of device due to infectionSurgical and medical procedures | 0/25 | 1/25 |
| Age, Continuous(years) | Cyclic SNM | Continuous SNM | Total |
|---|---|---|---|
| Mean | 69 ± 11 | 68 ± 10 | 68 ± 11 |
| Sex: Female, Male(Participants) | Cyclic SNM | Continuous SNM | Total |
|---|---|---|---|
| Female | 25 | 25 | 50 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cyclic SNM | Continuous SNM | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 8 |
| White | 20 | 22 | 42 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Only de-identified data will be shared with co-collaborators at Northwestern University (PI: Carol E. Bretschneider) and University of Louisville (PI: Ankita Gupta)
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center