Psychological and psychiatric factors as predictors for success in sacral neuromodulation treatment.

UNLABELLED: What's known on the subject? and What does the study add? Sacral neuromodulation (SNM) is a well-established treatment for patients with chronic LUTS. The selection of eligible candidates could be improved by identifying factors that can predict a successful response. In the present study, we evaluated the role of various psychological and psychiatric factors in relation to SNM treatment. OBJECTIVE: • To evaluate if psychological and psychiatric factors can predict the outcome of test stimulation or permanent treatment with sacral neuromodulation (SNM). PATIENTS AND METHODS: • Between 2006 and 2009, patients with overactive bladder syndrome or non-obstructive urinary retention who were eligible for test stimulation were included. • All patients completed the Amsterdam Biographic Questionnaire (ABQ), which measures the personality traits of the patient, and the Symptom Check-List-90-Revised (SCL-90-R), which is a screening instrument for neuroticism, and for current level of complaints. • The results of the questionnaires were compared with the outcomes of test stimulation and permanent treatment. • In addition to the questionnaires, we also included the psychiatric history as a potential predictive factor. RESULTS: • On univariate analysis there was no relationship between the psychological characteristics and the outcome of test stimulation or the occurrence of adverse events (AEs) with permanent treatment. • A history of psychiatric disease was not related to the outcome of test stimulation, but was shown to be a positive predictor for the occurrence of AEs with permanent SNM treatment. CONCLUSIONS: • In the present study there was no evidence that psychological screening with the ABQ or SCL-90-R can predict the outcome of SNM treatment. • Patients with a medical history of psychiatric disease appear to be more likely to encounter AEs with permanent SNM treatment.

PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy.

AIMS: To compare the patient's response rate to the Percutaneous Nerve Evaluation test (PNE) and the 1st stage tined-lead placement test (FSTLP) for sacral neuromodulation therapy (SNM). METHODS: Single center study on patients with refractory idiopathic overactive bladder syndrome (OAB) or non-obstructive urinary retention, screened with both PNE and FSTLP. Patients were followed prospectively and their response rate based on bladder diary after PNE was compared to that after FSTLP. More than 50% improvement in at least two relevant urinary symptoms was considered a positive response. A Wilcoxon paired test was done to compare the rates of the two screening options and logistic regression to determine possible associations. A follow-up was conducted to determine the long-term failure rate. RESULTS: One hundred patients were included (82 female, 69 OAB). The mean age was 55 years (SD 13). The positive response rate on PNE was 47%. FSTLP showed a 69% positive response rate, which was negatively related to age. The 22% gain in positive response was statistically significant (P < 0.001) and positively associated with female gender and younger age. All 69 patients with a positive response to FSTLP received SNM treatment. Failure rate after an average of 2 years was 2.9%. CONCLUSIONS: This study suggests that FSTLP may be a more sensitive screening method than PNE to identify patients eligible for SNM therapy, warranting randomized trials.

The effect of pulse rate changes on the clinical outcome of sacral neuromodulation.

PURPOSE: We evaluated the effect of pulse rate changes on the clinical response to and stimulation related pain symptoms of sacral neuromodulation treatment. MATERIALS AND METHODS: In this pilot study we evaluated the effect of 4 pulse rates, including 5.2, 10, 21 and 40 Hz, in patients with a suboptimal response to sacral neuromodulation. The effect of each frequency was evaluated during a 6-day test period. To avoid the carryover effect stimulation was discontinued for 24 hours between consecutive test periods. On the last 3 days of each test period a voiding diary and questionnaire were completed. Changes in the clinical response and pain symptoms were compared between the 4 pulse rates using multivariate analysis. RESULTS: Of the 50 patients included in the study 40 (80%) were female. Mean ± SD age was 55.5 ± 12.3 years. Of the patients 41 (82%) had overactive bladder symptoms and 9 (18%) were in chronic nonobstructive urinary retention. No significant difference was found in clinical outcome on the voiding diary and questionnaire between the pulse rates and none of the 4 rates was significantly related to sacral neuromodulation associated pain. However, individuals appeared to benefit from changing the pulse rate in terms of treatment efficacy and stimulation related pain. CONCLUSIONS: On the group level none of the 4 pulse rates appeared to have a significantly different effect on clinical outcome or sacral neuromodulation related pain. However, an individualized approach to optimize treatment efficacy by changing the pulse rate appears to be useful.

The use of bilateral sacral nerve stimulation in patients with loss of unilateral treatment efficacy.

PURPOSE: We evaluated whether bilateral sacral nerve stimulation can be effective to restore treatment efficacy in patients in whom unilateral sacral neuromodulation fails. MATERIALS AND METHODS: Patients in whom unilateral sacral neuromodulation failed were included in analysis. The percutaneous nerve evaluation test was used to evaluate the effect of contralateral and bilateral stimulation. The stimulation electrode was placed in the contralateral S3 foramen and symptoms were self-recorded using a 3-day voiding diary. Clinical success was defined as more than 50% improvement in at least 1 relevant voiding diary parameter vs baseline. RESULTS: The 15 study patients underwent test stimulation with percutaneous nerve evaluation. In 3 patients lead migration was suspected and, thus, they were not included in analysis. Four of the remaining 12 patients had a successful response to percutaneous nerve evaluation, of whom 3 were eventually implanted with a contralateral lead. After 12 months of treatment 2 of the 3 patients had a successful outcome. CONCLUSIONS: In this pilot study only a select group of patients appeared to benefit from bilateral stimulation after unilateral therapy failure. Further investigation is needed to determine the predictive factors and cost-effectiveness of this treatment.

Is the screening method of sacral neuromodulation a prognostic factor for long-term success?

PURPOSE: We evaluated whether there is a difference in long-term outcomes between patients screened with percutaneous nerve evaluation and a first stage tined lead procedure. We also evaluated the outcome in patients who only responded to screening with the tined lead procedure after failed initial percutaneous nerve evaluation. MATERIALS AND METHODS: We evaluated all patients screened for eligibility to receive sacral neuromodulation treatment since the introduction of the tined lead technique in our center in 2002. In May 2009 all implanted patients were asked to maintain a voiding diary to record the effect of sacral neuromodulation on urinary symptoms. Chi-square analysis was used to evaluate differences in the long-term outcomes of the separate screening methods. RESULTS: A total of 92 patients were screened for sacral neuromodulation. Of the 76 patients screened with percutaneous nerve evaluation 35 (46%) met the criteria for permanent implantation. In 11 of the 16 patients (69%) who underwent direct screening with the tined lead procedure permanent stimulators were placed. Of the 41 patients in whom percutaneous nerve evaluation failed and who subsequently underwent screening with tined lead procedure 18 (44%) were implanted with a neurostimulator after a successful response. Statistical analysis showed no difference between screening type and long-term success (p = 0.94). CONCLUSIONS: The first stage tined lead procedure is a more sensitive screening tool than percutaneous nerve evaluation but long-term success seems to be independent of the screening method. Patients in whom percutaneous nerve evaluation initially failed but who responded to prolonged screening the with tined lead procedure appeared to be as successful as those who directly responded to percutaneous nerve evaluation or the tined lead procedure.

Satisfaction and patient experience with sacral neuromodulation: results of a single center sample survey.

PURPOSE: We systematically assessed long-term satisfaction and patient experience with sacral nerve modulation therapy. MATERIALS AND METHODS: All patients who received sacral neuromodulation between 1990 and 2007 at our center and who still had the implant were included in the survey. All received a postal questionnaire regarding satisfaction and experiences with the system, such as side effects, complications, burden, impact on sexuality and defecation changes. RESULTS: Of the 275 questionnaires sent 207 were returned for a 75% response rate. The population was 83% female. Overall treatment was done for overactive bladder syndrome, nonobstructive urinary retention, combined overactive bladder and retention, and pelvic pain in 55%, 24%, 20% and 1% of patients, respectively. Overall satisfaction with sacral neuromodulation was high at 90%. No correlations were found between the satisfaction rate, and pretreatment age, gender, complaint type, sexual dysfunction or therapy duration. However, 56% of patients reported side effects, such as pain at the internal nerve stimulator site and due to stimulation. However, 89% of these patients did not seek further therapy. Of patients with additional defecation problems 47% experienced relief of complaints. CONCLUSIONS: This study shows a high satisfaction rate in patients with sacral neuromodulation. There was no relation between patient age, complaint type, therapy duration or side effects and the satisfaction rate. The number of side effects was limited but further analysis in prospective cohorts should identify patients who are likely to have side effects or stop sacral neuromodulation treatment.

Patient experience and satisfaction with sacral neuromodulation: results of a single-center sample survey.

PURPOSE: Sacral neuromodulation is a well researched and successful treatment for functional bowel disorders. Indications have expanded throughout the years and various studies have been published on clinical efficacy or on technique improvement. The main goal of this retrospective study was to systematically evaluate daily experiences with this treatment and measure the long-term satisfaction of sacral neuromodulation therapy for functional bowel disorders. METHODS: After institutional review board approval a new, self-designed postal questionnaire was sent to all patients in our center who were being treated with sacral neuromodulation. Only patients with a minimal follow-up of 1 year were included in the survey. Implantation years range from 2000 to 2007. RESULTS: A total of 174 patients received the questionnaire regarding patient satisfaction and experience with sacral neuromodulation therapy. The response rate after reminder letter was 71.8% (n = 125) including 114 (91.2%) females. Patient satisfaction was high: 81 patients (65.3%) reported their results as very satisfying, 30 patients (24.2%) were moderately satisfied, and 13 patients (10.4%) were not satisfied. Analysis showed that patient satisfaction can be explained by both patient perception of present bowel function and their evaluation of the quality of daily life. No significant relationship was found with patient demographics, self-ascribed (co)morbidity, behavioral habits, or therapy duration. A total of 47 patients (38.2%) reported having some concerns regarding the future with sacral neuromodulation treatment. Twenty-eight patients (23.1%) reported a temporary loss of effect at any time during sacral neuromodulation therapy. Pain at the implantation site was reported by 65 patients (52.4%). CONCLUSIONS: This study shows that patients treated with sacral neuromodulation, in general, are very satisfied. The main problems mentioned by patients are pain, loss of efficacy, and general concerns.

Cost-effectiveness analysis of sacral neuromodulation and botulinum toxin A treatment for patients with idiopathic overactive bladder.

UNLABELLED: Study Type - Therapy (economic analysis). LEVEL OF EVIDENCE: 1b. OBJECTIVE: To assess and compare the costs and effects value of either starting with sacral neuromodulation (SNM) or botulinum toxin A (BTX) treatment in patients with refractory idiopathic overactive bladder from a societal perspective. MATERIALS AND METHODS: An economic model comparing SNM with BTX was developed. A clinical relevant effect (i.e. success) was defined as 50% or greater reduction in incontinence episodes or urgency frequency symptoms. Information on the clinical effectiveness of the two treatments and on the course of the disease with the two treatments were based primarily on published literature and, when required, on expert opinion. Both treatments were assumed to be performed under general anaesthesia and, for SNM treatment, first-stage tined lead test was used. All costs were based on national data from the year 2008. Analyses from the societal perspective were conducted for a 5-year duration. Costs were discounted at 4% and effects at 1.5%. In addition, different modelling scenarios were used to see determine any changes in the results obtained. RESULTS: Starting with SNM resulted in a higher quality adjusted life year (QALY) gain (difference of 0.23) and a higher cost (difference of €6428) compared to starting with BTX. The corresponding incremental cost-effectiveness ratio was €27,991/QALY. The probability of this ratio being cost effective (e.g. under €40,000/QALY) is 88%. SNM starts to be cost-effective after 4 years. SNM was not cost-effective in some other scenarios, such as when BTX was conducted under local anaesthesia or when peripheral nerve evaluation or bilateral testing was used for SNM. CONCLUSIONS: Starting with SNM, treatment is cost-effective after 5 years compared to BTX. However, in some scenarios, such as the use of local anaesthesia for BTX treatment and SNM peripheral nerve evaluation or bilateral test, SNM was not cost-effective.

Long-term results of sacral neuromodulation with the tined lead procedure.

PURPOSE: We present long-term followup data on the outcome of sacral neuromodulation using the tined lead procedure. MATERIALS AND METHODS: We conducted a single center study including all patients who received an implantable neurostimulator between 2002 and 2005 using the tined lead technique. Treatment efficacy was evaluated by comparing the data of a 3-day voiding diary filled out in May 2009 to the data before the onset of sacral neuromodulation treatment (baseline). Clinical success was defined as more than 50% improvement in at least 1 of the relevant voiding diary parameters. RESULTS: A total of 64 patients underwent implantation with an implantable neurostimulator using the tined lead procedure. Mean followup was 53 months (range 35 to 77). Five patients died of causes unrelated to sacral neuromodulation and they were not included in analysis. The implantable neurostimulator was removed from 7 patients and 3 stopped using the neurostimulator. Voiding diary analysis showed that 38 of 59 patients (64%) were successfully treated. There were 21 patients (33%) who underwent a surgical revision due to an adverse event and 1 (1.6%) who underwent lead revision because of suspected lead migration. CONCLUSIONS: Sacral neuromodulation with the tined lead procedure is a safe and effective treatment for patients with overactive bladder symptoms or urinary retention.

Current information on sacral neuromodulation and botulinum toxin treatment for refractory idiopathic overactive bladder syndrome: a review.

The overactive bladder syndrome (OAB) negatively affects the daily life of many people. Conservative treatments, such as antimuscarinics, do not always lead to sufficient improvement of the complaints and/or are often associated with considerable side effects resulting in treatment failure. In the case of failure or intolerable side effects, sacral neuromodulation (SNM) and botulinum toxin are minimally invasive and reversible alternatives. Currently, of these alternatives only SNM with InterStimTM therapy has FDA approval for use in OAB patients. This review attempts to provide an update on the current position of SNM and botulinum toxin in the second-line management of adults with idiopathic OAB, based on the available clinical evidence concerning the efficacy and safety.