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Study Title and Description

Effect of Sacral Neuromodulation Rate on Overactive Bladder Symptoms: A Randomized Crossover Feasibility Study.



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
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Primary Publication Information
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TitleData
Title Effect of Sacral Neuromodulation Rate on Overactive Bladder Symptoms: A Randomized Crossover Feasibility Study.
Author Peters KM., Shen L., McGuire M.
Country Department of Urology, William Beaumont Hospital, Royal Oak, Michigan, USAMedtronic Neuromodulation, Minneapolis, Minnesota, USA.
Year 2013
Numbers Pubmed ID: 26663447

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: All studies
Arms
Number Title Description Comments
1 Sacral Neuromodulation 5.2 Hz
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2 Sacral Neuromodulation 14 Hz
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3 Sacral Neuromodulation 25 Hz
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries U.S.
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Funding source Industry funded/industry provided materials
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Inclusion criteria females over the age of 18 who had an SNM implant with a tined lead located at S3 for at least 3 months. All study subjects had a baseline diagnosis of UF and any amount of UI over the voiding diary-reporting period
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Exclusion criteria history of neurological disorders, diabetes unless it was well-controlled through diet and/or medications, or a primary diagnosis of stress incontinence, pelvic pain, or interstitial cystitis
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UI type 100
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Age 60.9
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mean
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6.1
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Men included 0
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Special populations 12
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100
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Race 12
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100
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Notes
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Did participants fail previous treatment? ... Yes ... subject was refractory to conventional therapy, including antimuscarinic medications
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Study years 2009-2010
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Trial name (if given)
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question Sacral Neuromodulation 5.2 Hz Sacral Neuromodulation 14 Hz Sacral Neuromodulation 25 Hz Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 13
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12
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1
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poor compliance
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Notes No data entered.



Results & Comparisons

No Results found.

Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Low RoB
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RCT:.....Blinding of PATIENTS Low RoB
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RCT.....Intention-to-treat-analysis Low RoB
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High RoB
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ALL.....Incomplete results data (attrition bias) Low RoB
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions Low RoB
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NRCS.....Patients in different intervention groups selected in an equivalent manner
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
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ALL.....Other issues
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.