Does response to percutaneous tibial nerve stimulation predict similar outcome to sacral nerve stimulation?

AIMS: Percutaneous tibial nerve stimulation (PTNS) is a simple neuromodulation technique to treat an overactive bladder. It is unclear whether the response to PTNS would suggest a similar response to sacral nerve stimulation (SNS), and whether PTNS could be utilized as an alternative test phase for an SNS implant. This study assessed whether PTNS response was a reliable indicator for subsequent SNS trials. METHODS: We performed a retrospective review of the hospital databases to collect all patients who had PTNS and who subsequently had an SNS trial in two tertiary hospitals from 2014 to 2020. Response to both interventions was assessed. A 50% reduction in overactive symptoms (frequency-volume charts) was considered a positive response. McNemar's tests using exact binomial probability calculations were used. The statistical significance level was set to 0.05. RESULTS: Twenty-three patients who had PTNS subsequently went on to a trial of SNS. All patients except one had previously poor response to PTNS treatment. Eight of them also failed the SNS trial. However, 15 patients (including the PTNS responder) had a successful SNS trial and proceeded with the second-stage battery implantation. The difference in response rates between the PTNS and SNS trial was statistically significant (p < 0.001). CONCLUSIONS: Poor response to PTNS does not seem to predict the likelihood of patients responding to SNS. A negative PTNS trial should not preclude a trial of a sacral nerve implant. The predictive factors for good and poor responses will be the subject of a larger study.

A prospective, multicenter, international study to explore the effect of three different amplitude settings in female subjects with urinary urge incontinence receiving interstim therapy.

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.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented. METHODS: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. RESULTS: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events. CONCLUSIONS: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

Outcomes following percutaneous tibial nerve stimulation (PTNS) treatment for neurogenic and idiopathic overactive bladder.

PURPOSE: Percutaneous tibial nerve stimulation is a minimally invasive neuromodulation technique for treating overactive bladder symptoms. The aim of this study was to assess safety, efficacy and impact on quality of life of percutaneous tibial nerve stimulation in neurological patients reporting overactive bladder symptoms. METHODS: In this retrospective evaluation over 18 months at a tertiary healthcare centre, patients finding first-line treatments for overactive bladder ineffective or intolerable underwent a standard 12-week course of percutaneous tibial nerve stimulation (Urgent PC, Uroplasty). Symptoms were evaluated using standardised International Consultation on Incontinence Questionnaires and bladder diaries. RESULTS: Of 74 patients (52 women, 22 men, mean age 56 years), 49 (66.2%) patients had neurological disorder [19 (25.7%) multiple sclerosis and 30 (40.5%) other neurological conditions] and 25 (33.8%) idiopathic overactive bladder. Overall for the entire cohort significant improvements were recorded after 12 weeks in the following domains: 24-h frequency on bladder diary - 1.67 (- 3.0, 0.33) (p = 0.002), number of incontinent episodes on bladder diary - 0.0 (- 1, 0) (p = 0.01), incontinence severity on bladder diary 0 (- 0.33, 0) (p = 0.007), OAB symptoms - 3 (- 11.5, 5) (p = 0.01), and quality of life - 16 (- 57, 6.5) (p = 0.004). There were no significant differences in outcomes between patients with idiopathic and neurogenic overactive bladder. CONCLUSIONS: Percutaneous tibial nerve stimulation appears to be a possible promising alternative for patients with neurological disorder reporting overactive bladder symptoms who find first-line treatments either ineffective or intolerable. However, a properly designed study is required to address safety and efficacy.

Factors influencing return for maintenance treatment with percutaneous tibial nerve stimulation for the management of the overactive bladder.

OBJECTIVES: To identify factors influencing return for maintenance percutaneous tibial nerve stimulation (PTNS) treatment after successful completion of a 12-week course of treatment for overactive bladder (OAB). PATIENTS AND METHODS: Patients with OAB symptoms referred for PTNS treatment underwent 12 sessions of weekly PTNS treatment and were evaluated at baseline and week 12 using the International Consultation on Incontinence Questionnaire on OAB, the International Consultation on Incontinence Questionnaire on lower urinary tract symptom-related quality of life (ICIQ-LUTSqol) and a bladder diary (BD). Responders to treatment, evaluated using two patient-reported outcome measures, were invited to return for maintenance treatment when symptoms returned. A PTNS Service Evaluation Questionnaire was used to evaluate factors influencing return for maintenance treatment. RESULTS: Seventy-three patients were evaluated (mean age 58.9 [±14.7] years, 72.6% women) and clustered into three groups: group 1 (n = 25) did not respond to 12 weekly sessions of PTNS treatment; group 2 (n = 17) responded to treatment but did not return for maintenance treatment and group 3 (n = 31) responded to treatment and returned for maintenance treatment. There were no significant differences in demographic characteristics, diagnosis, baseline symptom scores and BD variables among the three groups. Patients belonging to groups 2 and 3 experienced a significant improvement from baseline to week 12 in total OAB scores (group 2: -1.54 ± 1.85; group 3: -1.85 ± 2.28; P < 0.05); however, patients returning for maintenance treatment reported significant improvements specifically in nocturia (BD difference = -0.4 ± 0.7 [P < 0.05] and ICIQ-LUTSqol difference -0.48 ± 0.94 [P < 0.05]), and perceived benefits of the treatment with regard to their OAB symptoms compared to those not returning for maintenance treatment (difference between the two groups 25.6%; P = 0.030). Improvements in nocturia and perceived benefits predicted return for maintenance treatment based on a logistic regression analysis. Factors related to the need for repeat clinic visits, such as transportation, distance and time commitment, were not found to differ between the two groups. CONCLUSIONS: Twelve-session weekly PTNS is a safe and effective treatment for OAB. Responders to treatment returning for maintenance PTNS more often reported significant improvements in nocturia and perceived benefits over time, compared to those not returning for maintenance treatment. The BD provides a more objective assessment of treatment outcome after PTNS treatment.