The aim of the study was to identify the possible relationship between body mass index and intra-abdominal pressure as measured by multichannel cystometry. A retrospective chart review of patients presenting for urodynamic evaluation between January 1995 and March 1996 was carried out. Variables identified included weight, height, intra-abdominal pressure and intravesical pressure as recorded on multi-channel cystometrogram at first sensation in the absence of detrusor activity. Body mass index was defined as weight in kilograms divided by height in square meters. Intra-abdominal pressure was measured intravaginally except in those cases of complete procidentia or severe prolapse, where it was measured transrectally. Adequate data were available on 136 patients. The mean age was 60.6 years (range 30-91); mean body mass index was 27.7 kg/m2 (range 12.7-47.7); and mean intra-abdominal pressure was 27.5 cmH2O (range 9.0-48.0). A strong association between intra-abdominal pressure and body mass index was demonstrated, with a Pearson coefficient correlation value of 0.76 (P<0.0001). Strong correlation was still demonstrated when those patients who had had the intra-abdominal pressure measured transrectally were separated out, thus eliminating any possible confounding factors between measurements of intra-abdominal pressure measured transvaginally versus transrectally. In addition a strong correlation between intravesical pressure and body mass index was also demonstrated, with a Pearson coefficient correlation value of 0.71 (P<0.0001). Of the 136 patients, 65 (47.8%) were ultimately diagnosed as having genuine stress urinary incontinence (GSUI), 35 (25.7%) with GSUI and a low-pressure urethra (maximum urethral closure pressure of less than 20 cmH2O), and 18 (13.2%) with detrusor instability. The remaining 13.2% had severe prolapse. Our data demonstrate a significant correlation between body mass index and intra-abdominal pressure. These findings suggest that obesity may stress the pelvic floor secondary to chronic state of increased pressure, and may represent a mechanism which supports the widely held belief that obesity is a common factor in the development and recurrence of GSUI.
This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.
Aims: This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim 1 Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). Methods: Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (!2 leaks/72 hr) and/or urgency-frequency (!8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT. Results: Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P ¼ 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P ¼ 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. Conclusions: This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224-230, 2015. # 2014 Wiley Periodicals, Inc.
Aims: This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim 1 System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included. Methods: Subjects with successful test stimulation received an SNM implant. Therapeutic success (!50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects. Results: Of the 340 subjects that went through test stimulation, 272 were implanted with SNM. Of these, 91% were female, mean age was 57, UI subjects had 3.1 AE 2.7 leaks/day, UF subjects had 12.6 AE 4.5 voids/day. The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months. UI subjects had a mean reduction of 2.2 AE 2.7 leaks/day; UF subjects had a mean reduction of 5.1 AE 4.1 voids/day (both P < 0.0001). Subjects showed significant improvement from baseline in all measures of ICIQ-OABqol (all P < 0.0001). 80% of subjects reported improved changes in their urinary symptom interference at 12 months. Device-related adverse events occurred in 16% (56/340) of subjects during test stimulation and 30% (82/272) of subjects post-implant. Conclusions: This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications. Neurourol. Urodynam. 35:246-251, 2016.
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