A prospective, multicenter, international study to explore the effect of three different amplitude settings in female subjects with urinary urge incontinence receiving interstim therapy
| Autor: | Dean Elterman, Kira Stolen, Sagar R. Shah, Raviender Bukkapatnam, Mahreen Pakzad, Michael J. Ehlert, Dirk De Ridder, Colin Goudelocke, Lance Zirpel, Melissa R. Kaufman, Eric Margolis, Mylène Champs, Gayle Johnson, Rebecca McCrery |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Randomization sensory thresholds Urology Urinary system 030232 urology & nephrology Electric Stimulation Therapy Urinary incontinence sacral neuromodulation 03 medical and health sciences 0302 clinical medicine Quality of life Sensory threshold Original Clinical Article Humans Medicine Prospective Studies Prospective cohort study 030219 obstetrics & reproductive medicine Science & Technology urinary incontinence business.industry Urinary Incontinence Urge Middle Aged Urology & Nephrology medicine.disease Confidence interval Overactive bladder quality of life Physical therapy Female overactive bladder Neurology (clinical) medicine.symptom Original Clinical Articles business Life Sciences & Biomedicine |
| Zdroj: | Neurourology and Urodynamics |
| Popis: | AIMS: The aim of this study is to evaluate the effect of sub-sensory amplitude settings of sacral neuromodulation therapy on overactive bladder symptoms in subjects with urinary urge incontinence. METHODS: Subjects who qualified for a neurostimulator device implant were randomized to one of three amplitude settings (50% of sensory threshold [ST], 80% of ST, and ST). Subjects completed urinary voiding diaries (3-day), International consultation on incontinence modular questionnaire-overactive bladder symptoms quality of life questionnaire, and patient global impression of improvement (PGI-I) to assess change in voiding symptoms and quality of life (QoL) from baseline through 12 weeks. RESULTS: Forty-eight subjects had a successful test stimulation, 46 were implanted with a neurostimulator device and 43 completed the 12-week follow-up visit. The change from baseline to 12 weeks is -3.0 urinary incontinence (UI) episodes/day (95% confidence interval [CI]: -4.4 to -1.7) for the 50% of sensory threshold group, -2.9 UI episodes/day (95% CI: -4.7 to -1.2) for 80% of sensory threshold group, and -3.6 UI episodes/day (95% CI: -5.2 to -1.9) for the sensory threshold group. In each randomized group, improvements were observed in health-related QoL, its subscales, and symptom interference. Subjects across all three randomization groups reported on the PGI-I that their bladder condition was better at 12 weeks compared to before they were treated with InterStim therapy. CONCLUSION: These findings provide insights into possible advancements in the postimplantation phase of therapy with potential for improved patient comfort and increased device longevity. ispartof: NEUROUROLOGY AND URODYNAMICS vol:40 issue:3 pages:920-928 ispartof: location:United States status: published |
| Databáze: | OpenAIRE |
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