Overactive Bladder Syndrome
Conditions
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.
Interventions
DEVICECyclic SNM
SNM cycling: 8 hours on, 16 hours off
DEVICEContinuous SNM
Continuous SNM: on continuously, no 'off' period
Sponsors
University Hospitals Cleveland Medical Center
Northwestern University
University of Louisville
Metro Health, Michigan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ICIQ-OAB-QoL Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in ICIQ-OAB-QoL Score | 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 |
| Change in OAB-q SF | 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 |
| Change in Overactive Bladder Symptom Score (OABSS) | 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. |
| Change in Incontinence Impact Questionnaire SF (IIQ-7) | 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 |
| Urinary Distress Inventory SF (UDI-6) | 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. |
| Patient Global Impression of Severity (PGI-S) | 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. |
| Patient Global Impression of Improvement (PGI-I) | 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 |
| Overactive Bladder Satisfaction of Treatment Questionnaire | 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 |
| Change in Voiding Episodes Per Day | 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. |
| Change in Voiding Episodes Per Night | 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. |
| Change in Pads Per Day | 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. |
| Change in Urge Incontinence Episodes Per Day | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Sheyn, MD
UH Hospitals Cleveland Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 10 / 25 | 11 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
None listed