Sacral Nerve Stimulation Reduces Elevated Urinary Nerve Growth Factor (UNGF) Levels in Women with Detrusor Overactivity

ObjectivesTo investigate changes in urinary nerve growth factor (uNGF) in women with detrusor overactivity (DO) before and after peripheral nerve evaluation for sacral neuromodulation vs. control subjects.Materials and methodsThis is a prospective analysis of women who presented to the North Shore-LIJ Health System between August 11, 2011 and March 13, 2013. Subjects were enrolled in the study if they had symptoms of DO including urinary frequency, urgency, or urge incontinence for greater than 3 months, a urodynamic diagnosis of DO, and experienced no improvement following treatment with anticholinergics and behavioral modifications. Age-matched controls (+/- 5 years) reported no symptoms of urinary frequency, urgency, or incontinence and provided a clean-catch urine specimen. At baseline, all subjects completed a 3-day voiding diary, Incontinence Quality of Life Questionnaire (I-QOL), and the Urinary Distress Inventory Questionnaire (UDI-6). A clean-catch mid-stream urine specimen was collected for uNGF and creatinine (Cr). DO subjects then underwent a 5-day peripheral nerve evaluation (PNE) trial for sacral neuromodulation. A voiding diary was completed each day of the PNE trial. After 5 days, subjects returned for follow-up and lead removal. The follow-up visit included collection of a clean-catch urine specimen and completion of I-QOL and UDI-6 questionnaires. The uNGF levels were measured by ELISA and expressed as uNGF pg/Cr mg. Group differences (comparing subjects vs. controls) for uNGF/Cr levels were tested using the non-parametric Mann-Whitney test. Changes in DO subject uNGF/Cr levels (from baseline to post-PNE) and quality of life measures before and after PNE were compared using the Wilcoxon signed-rank test. P values < 0.05 were considered significant.ResultsTwenty-three patients with DO and 22 age-matched controls met inclusion criteria and were enrolled in the study. Subjects with DO had significantly higher baseline uNGF levels compared to controls (19.82 pg/mg vs. 7.88 pg/mg, p < 0.002). Seventeen DO subjects underwent PNE and were evaluated at the end of the testing period. There was a significant improvement in quality of life scores for subjects after PNE compared to baseline (UDI-6: 7.0 vs. 13.7, p < 0.001; I-QOL: 87.3 vs. 52.8, p < 0.0001), as well as a decrease in median number of leaks (-2.5) and voids (-7.0). Concordantly, uNGF levels significantly decreased from 17.23 pg/mg to 9.24 pg/mg (p < 0.02) after PNE.ConclusionThe uNGF levels were shown to correlate with therapeutic responses in DO subjects undergoing PNE. Subjects with DO had significantly higher uNGF at baseline versus controls, and uNGF levels significantly decreased after only 5 days of sacral nerve stimulation. These findings support a larger study to validate the use of uNGF as an objective tool to assess therapeutic outcome in patients undergoing PNE for sacral neuromodulation.DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS:Dara Shalom: Medtronics, Principal Investigator, Research grantNirmala Pillalamarri: Nothing to discloseHarvey Winkler: Nothing to discloseLawrence Lind: Nothing to discloseChristine Metz: Nothing to disclose ObjectivesTo investigate changes in urinary nerve growth factor (uNGF) in women with detrusor overactivity (DO) before and after peripheral nerve evaluation for sacral neuromodulation vs. control subjects. To investigate changes in urinary nerve growth factor (uNGF) in women with detrusor overactivity (DO) before and after peripheral nerve evaluation for sacral neuromodulation vs. control subjects. Materials and methodsThis is a prospective analysis of women who presented to the North Shore-LIJ Health System between August 11, 2011 and March 13, 2013. Subjects were enrolled in the study if they had symptoms of DO including urinary frequency, urgency, or urge incontinence for greater than 3 months, a urodynamic diagnosis of DO, and experienced no improvement following treatment with anticholinergics and behavioral modifications. Age-matched controls (+/- 5 years) reported no symptoms of urinary frequency, urgency, or incontinence and provided a clean-catch urine specimen. At baseline, all subjects completed a 3-day voiding diary, Incontinence Quality of Life Questionnaire (I-QOL), and the Urinary Distress Inventory Questionnaire (UDI-6). A clean-catch mid-stream urine specimen was collected for uNGF and creatinine (Cr). DO subjects then underwent a 5-day peripheral nerve evaluation (PNE) trial for sacral neuromodulation. A voiding diary was completed each day of the PNE trial. After 5 days, subjects returned for follow-up and lead removal. The follow-up visit included collection of a clean-catch urine specimen and completion of I-QOL and UDI-6 questionnaires. The uNGF levels were measured by ELISA and expressed as uNGF pg/Cr mg. Group differences (comparing subjects vs. controls) for uNGF/Cr levels were tested using the non-parametric Mann-Whitney test. Changes in DO subject uNGF/Cr levels (from baseline to post-PNE) and quality of life measures before and after PNE were compared using the Wilcoxon signed-rank test. P values < 0.05 were considered significant. This is a prospective analysis of women who presented to the North Shore-LIJ Health System between August 11, 2011 and March 13, 2013. Subjects were enrolled in the study if they had symptoms of DO including urinary frequency, urgency, or urge incontinence for greater than 3 months, a urodynamic diagnosis of DO, and experienced no improvement following treatment with anticholinergics and behavioral modifications. Age-matched controls (+/- 5 years) reported no symptoms of urinary frequency, urgency, or incontinence and provided a clean-catch urine specimen. At baseline, all subjects completed a 3-day voiding diary, Incontinence Quality of Life Questionnaire (I-QOL), and the Urinary Distress Inventory Questionnaire (UDI-6). A clean-catch mid-stream urine specimen was collected for uNGF and creatinine (Cr). DO subjects then underwent a 5-day peripheral nerve evaluation (PNE) trial for sacral neuromodulation. A voiding diary was completed each day of the PNE trial. After 5 days, subjects returned for follow-up and lead removal. The follow-up visit included collection of a clean-catch urine specimen and completion of I-QOL and UDI-6 questionnaires. The uNGF levels were measured by ELISA and expressed as uNGF pg/Cr mg. Group differences (comparing subjects vs. controls) for uNGF/Cr levels were tested using the non-parametric Mann-Whitney test. Changes in DO subject uNGF/Cr levels (from baseline to post-PNE) and quality of life measures before and after PNE were compared using the Wilcoxon signed-rank test. P values < 0.05 were considered significant. ResultsTwenty-three patients with DO and 22 age-matched controls met inclusion criteria and were enrolled in the study. Subjects with DO had significantly higher baseline uNGF levels compared to controls (19.82 pg/mg vs. 7.88 pg/mg, p < 0.002). Seventeen DO subjects underwent PNE and were evaluated at the end of the testing period. There was a significant improvement in quality of life scores for subjects after PNE compared to baseline (UDI-6: 7.0 vs. 13.7, p < 0.001; I-QOL: 87.3 vs. 52.8, p < 0.0001), as well as a decrease in median number of leaks (-2.5) and voids (-7.0). Concordantly, uNGF levels significantly decreased from 17.23 pg/mg to 9.24 pg/mg (p < 0.02) after PNE. Twenty-three patients with DO and 22 age-matched controls met inclusion criteria and were enrolled in the study. Subjects with DO had significantly higher baseline uNGF levels compared to controls (19.82 pg/mg vs. 7.88 pg/mg, p < 0.002). Seventeen DO subjects underwent PNE and were evaluated at the end of the testing period. There was a significant improvement in quality of life scores for subjects after PNE compared to baseline (UDI-6: 7.0 vs. 13.7, p < 0.001; I-QOL: 87.3 vs. 52.8, p < 0.0001), as well as a decrease in median number of leaks (-2.5) and voids (-7.0). Concordantly, uNGF levels significantly decreased from 17.23 pg/mg to 9.24 pg/mg (p < 0.02) after PNE. ConclusionThe uNGF levels were shown to correlate with therapeutic responses in DO subjects undergoing PNE. Subjects with DO had significantly higher uNGF at baseline versus controls, and uNGF levels significantly decreased after only 5 days of sacral nerve stimulation. These findings support a larger study to validate the use of uNGF as an objective tool to assess therapeutic outcome in patients undergoing PNE for sacral neuromodulation.DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS:Dara Shalom: Medtronics, Principal Investigator, Research grantNirmala Pillalamarri: Nothing to discloseHarvey Winkler: Nothing to discloseLawrence Lind: Nothing to discloseChristine Metz: Nothing to disclose The uNGF levels were shown to correlate with therapeutic responses in DO subjects undergoing PNE. Subjects with DO had significantly higher uNGF at baseline versus controls, and uNGF levels significantly decreased after only 5 days of sacral nerve stimulation. These findings support a larger study to validate the use of uNGF as an objective tool to assess therapeutic outcome in patients undergoing PNE for sacral neuromodulation.