Sacral neuromodulation for the treatment of refractory interstitial cystitis: outcomes based on technique

Patients with refractory interstitial cystitis (IC) underwent testing with sacral nerve modulation via either a traditional percutaneous approach or a staged procedure. Implanted patients were followed with scaled questionnaires and voiding diaries. Twenty-six patients who had a permanent InterStim placed had a reduction in 24-h voids of 51%. More than two-thirds of patients reported a moderate or marked improvement in urinary frequency, urgency, pelvic pain, pelvic pressure, incontinence and overall quality of life. The test to implant rate of a traditional percutaneous procedure was 52%, compared to a staged procedure of 94%. Assessing sensory response at the time of implant reduced the reoperation rate from 43% to 0%. Ninety-six per cent stated they would undergo an implant again and recommend the therapy to a friend. We concluded that sacral nerve modulation can treat refractory IC symptoms. The response to therapy and the reoperation rate are dependent on the technique used to test and implant the device.Abbreviations IC Interstitial cystitis - TENS Transcutaneous electrical nerve stimulation Editorial Comment: The authors nicely describe a very difficult subset of patients with interstitial cystitis. The patients in this paper have failed six prior treatment modalities before undergoing sacral neural modulation. In this small series the response to therapy and reoperation rate was dependent on the technique used to test and implant the device. Sacral neuromodulation using the staged technique does show significant benefit in the treatment of refractory interstitial cystitis.     

Sacral neuromodulation decreases narcotic requirements in refractory interstitial cystitis

OBJECTIVE: To assess the efficacy of long-term sacral neuromodulation (InterStim(R), Medtronic Inc., Minneapolis, MN) in treating chronic pelvic pain associated with interstitial cystitis (IC, a symptom complex of urinary urgency, frequency and pelvic pain, often necessitating narcotics) refractory to standard therapy. PATIENTS AND METHODS: Twenty-one patients (17 female, four male, mean age 45.5 years, range 17-68) with refractory IC with chronic pelvic pain were reviewed retrospectively. In these patients a mean of six previous treatments for IC had failed. All patients had had cystoscopy and hydrodistension to confirm their diagnoses. All had a permanent InterStim device implanted by one surgeon (K.M.P.) between 2000 and 2002, after responding to a temporary test. Data were collected from chart reviews and patient questionnaires. Intramuscular morphine dose equivalents (MDEs) were calculated before and after implantation. RESULTS: All 21 patients responded to the questionnaire; the mean (range) follow-up after implantation was 15.4 (7.4-23.1) months. Eighteen patients used chronic narcotics before the InterStim and 20 reported moderate or marked improvement in pain afterward. The mean MDE decreased from 81.6 to 52.0 mg/day (36%) after implantation (P = 0.015). Four of 18 patients stopped all narcotics after InterStim implantation. CONCLUSIONS: Sacral neuromodulation decreases narcotic requirements and subjective pelvic pain in patients with refractory IC. Further decreases in MDE are anticipated as dose reductions continue in patients who improved.     

Sacral neuromodulation in patients with interstitial cystitis: a multicenter clinical trial

Female patients with interstitial cystitis (IC) unresponsive to standard oral and intravesical therapy were enrolled at three clinical sites for percutaneous sacral nerve root stimulation (PNS) in a prospective, observational pilot study. Evaluation was in the form of a 3-day voiding diary completed both prior to and following the commencement of sacral nerve root stimulation. Symptoms were also assessed by the O'Leary–Sant Interstitial Cystitis Symptom and Problem Indices (ICSI and ICPI). Baseline and test stimulation values for voiding diary parameters and O'Leary–Sant scores were compared to determine treatment efficacy. A total of 33 patients were enrolled. Statistically significant improvements were seen in frequency, pain, average voided volume and maximum voided volume. Significant improvements were also seen in ICSI and ICPI scores. Subacute PNS appears to be effective in reducing symptom severity and increasing voided volumes in patients with IC previously unresponsive to standard therapy. Abbreviations IC Interstitial cystitis - SNS Sacral nerve root stimulation - PNS Percutaneous sacral nerve root stimulation - ICSI Interstitial Cystitis Symptom Index - ICPI Interstitial Cystitis Problem IndexEditorial Comment: The authors demonstrate that temporary sacral nerve stimulation improves the symptoms of refractory interstitial cystitis. This is a well-designed, multi-institutional prospective study using both objective and validated subjective markers to measure outcomes. This paper, along with other previously published studies on sacral neuromodulation for IC, lends support for additional investigations into sacral neuromodulation for refractory IC. Interstitial cystitis can be a difficult disease to treat and patients who are refractory to standard IC therapies either continue to suffer from their symptoms or have only major, irreversible, surgery as their sole option. Reconstructive surgery for IC often leads to poor clinical outcomes. Well-designed studies with long-term follow-up and careful reporting of outcomes of permanent implantation of a pulse generator are needed in IC. If sacral nerve stimulation is shown to improve the symptoms of IC, this will provide a reversible modality to enhance the quality of life of those suffering from this difficult disease.     

Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomized clinical trial

OBJECTIVES: To compare the effectiveness of sacral root neuromodulation with that of conservative management in ameliorating symptoms of refractory urinary urge incontinence and enhancing quality of life, to assess the objective response to neuromodulation as revealed by urodynamic testing, and to delineate the long-term outcomes of neuromodulation. METHODS: Forty-four patients with refractory urge incontinence were randomized to undergo neuromodulation with an implantable impulse generator (n = 21) or to continue their prior conservative management (n = 23). At 6 months the control group was eligible for crossover to implant. Patient evaluation included voiding diaries, quality of life questionnaires, urodynamic testing, and documentation of adverse events. Long-term follow-up evaluations were conducted at 6-month intervals up to 36 months. RESULTS: At 6 months mean leakage episodes, leakage severity and pad usage in the implant group were significantly lower by 88% (p < 0.0005), 24% (p = 0.047) and 90% (p < 0.0005), respectively, than the corresponding control group mean values. Improvements in leakage episodes and pad usage of >/=90% were attained by 75 and 85% of the implant group, respectively, but none of the control group. One third of implant patients, but none of the control patients, achieved >/=50% improvement in leakage severity. Over half of the implant patients (56%) were completely dry compared with 1 control patient (4%). Implant patients, but not control patients, exhibited significant improvement with respect to two quality of life measures. Neuromodulation resulted in increases of 220% (p < 0.0005) and 39% (p = 0.013), respectively, in urodynamically assessed bladder volume at first contraction and maximum fill. At 36 months the actuarial rate of treatment failure was 32.4% (95% CI, 17.0-56.0%). Adverse events most frequently involved pain at the implant site, and the incidence of serious complications was low. CONCLUSIONS: Neuromodulation is markedly more effective than conservative management in alleviating symptoms of refractory urge incontinence. Quality of life and urodynamic function are also improved by neuromodulation. The effects of neuromodulation are long-lasting, and associated morbidity is low.     

Sacral nerve neuromodulation in the treatment of patients with refractory motor urge incontinence: long-term results of a prospective longitudinal study

PURPOSE: Conservative treatment rarely results in a durable cure of patients with urge incontinence and bladder overactivity. Instrumental and surgical procedures often have significant side effects and less than optimal results. We developed a technique of sacral nerve neuromodulation using chronic unilateral electrical stimulation of the S3 sacral nerve to inhibit the micturition reflex to provide effective nondestructive alternative therapy for patients whose condition is refractory to conservative treatment. MATERIALS AND METHODS: Of 85 patients 45 who responded to a test with a temporary electrode underwent implantation of a permanent S3 sacral nerve electrode coupled to a pulse generator. Treatment results were evaluated by urodynamic studies and voiding/incontinence diaries documenting pad use, incontinence episodes, voiding frequency and voided volume. Partial success and cure were defined as 50% to 90% and more than 90% improvement, respectively, in pad use and/or incontinence episodes. RESULTS: Of 45 patients 18 (40%) were cured at an average followup of 47.1 months and 9 (20%) achieved partial success. Median number of pads used and median number of incontinence episodes daily had decreased from 5.4 to 1.2 (p = 0.0001) and 7.1 to 1.3 (p = 0.0001), respectively, 6 months after implantation. Subsequently these results remained almost constant for 5 years. Bladder overactivity disappeared in 19 of the 44 patients (43%). The repeat intervention rate was 37.7% and there was no permanent injury or nerve damage. CONCLUSIONS: Sacral nerve neuromodulation is safe, effective and durable in patients with urge incontinence refractory to conservative treatment.     

神经调节器永久性植入治疗间质性膀胱炎合并盆底疼痛四例报告

目的探讨间质性膀胱炎合并盆底疼痛进行骶神经电刺激神经调节治疗的疗效。方法2004年11月至2005年12月,采用美国国立糖尿病、消化病和肾病研究所(NIDDK)制定的标准诊断间质性膀胱炎合并盆底疼痛者4例,并接受永久性神经调节器植入。结果4例经永久性神经调节器植入后,分别随访3-8个月,排尿日记24 h平均尿量由治疗前90-110(96．3±9．3)ml升至治疗后的192～212(201．0±9．2)ml,P<0．05),24 h排尿次数由治疗前的15-25(20．3±4．1)次降至7～12(9．8±2．2)次(P<0．05),夜尿次数由治疗前的8～11(9.8±1.5)次降至治疗后3-6 (4．3±1．3)次(P<0．05),排尿疼痛评分由治疗前的7～10(8．8±1．5)分降至治疗后的1～4(1．8±1．5)分(P<0．01);O'Leary-Sant间质性膀胱炎指数评分由治疗前的均为满分(36分)降至治疗后的8 -11(9．3±1．5)分(P<0．01)。膀胱疼痛和盆底疼痛症状明显缓解,尿频症状也明显改善。结论骶神经电刺激神经凋节治疗是治疗间质性膀胱炎合并盆底疼痛有效、安全的治疗手段。     

Hyperbaric oxygen for the treatment of interstitial cystitis: long-term results of a prospective pilot study

OBJECTIVE: We conducted a prospective pilot study to assess the safety and efficacy of hyperbaric oxygen (HBO) for the treatment of interstitial cystitis (IC). METHODS: Six patients underwent 30 sessions of 100% oxygen inhalation in a hyperbaric chamber and were followed up over 15 months. The measures of efficacy were changes in pain and urgency (visual analog scales), alteration in the patient's assessment of overall change in his well-being (Patient Global Assessment Form), and changes in frequency and functional bladder capacity (48-hours voiding log). Evaluation of symptom severity regarding pain and voiding problems was done using the O'Leary-Sant index. RESULTS: Four patients rated the therapeutic result as either excellent or good and assessed their well-being after HBO treatment as improved. Two patients showed only short-term amelioration of some of their symptoms. At 12 months follow-up the baseline functional bladder capacity increased from 37-161 ml (range) to 160-200 ml in the responder group. The 24-hour voiding frequency decreased from 15-27 to 6-11 voids per day, a pain scale improvement from 20-97 mm at baseline to 3-30 mm at 12 months follow-up and an urgency scale improvement from 53-92 mm to 3-40 mm, respectively was observed at 12 month follow-up. The symptom and pain index score decreased from 23-35 at baseline to 3-17 at 12 months follow-up. CONCLUSION: HBO appears to be effective to treat IC patients. Treatment was well tolerated and resulted in a sustained decrease of pelvic pain and urgency, improvement of voiding patterns and increase of functional bladder capacity for at least 12 months.     

Percutaneous sacral nerve root neuromodulation for intractable interstitial cystitis

PURPOSE: We evaluated the efficacy of percutaneous sacral nerve root neuromodulation in women with refractory interstitial cystitis. MATERIAL AND METHODS: We prospectively evaluated 15 consecutive women with a mean age of 62 years who had refractory interstitial cystitis to determine the efficacy of percutaneous stimulation of the S3 sacral roots. The mean duration of symptoms before evaluation was 5.2 years. All women fulfilled the National Institute of Arthritis, Diabetes and Digestive and Kidney Diseases criteria for the diagnosis of interstitial cystitis and were unresponsive to standard oral or intravesical therapy. The response to treatment was assessed using pain scores, urinary diary variables and quality of life surveys. RESULTS: Mean voided volume during treatment increased from 90 to 143 ml. (p <0.001). Mean daytime frequency and nocturia decreased from 20 to 11 and 6 to 2 times (p = 0.012 and 0.007, respectively). Mean bladder pain decreased from 8.9 to 2.4 points on a scale of 0 to 10 (p <0.001). As indicated by the Short Urinary Distress Inventory and SF-36 Health Survey, the quality of life parameters of social functioning, bodily pain and general health significantly improved during the stimulation period. Of the women 73% requested to proceed to complete sacral nerve root implantation. CONCLUSION: Women with intractable interstitial cystitis respond favorably to percutaneous sacral stimulation with significant improvement in pelvic pain, daytime frequency, nocturia, urgency and average voided volume. Permanent sacral implantation may be an effective treatment modality in refractory interstitial cystitis but further long-term evaluation is required.     

Sacral neuromodulation for the treatment of bladder dysfunction

S3 nerve root neuromodulation is becoming an accepted therapy for individuals afflicted with lower urinary tract symptoms, such as idiopathic urinary urge incontinence, frequency, urgency, and urinary retention, who fail current standard therapies. This patient population is difficult to treat, and this therapy offers an option that can restore quality of life to these individuals. While the precise pathophysiologic mechanisms underlying these voiding symptoms is unknown based on the physiology of bladder function, it is logical to conclude that they relate to some aberration of the neuromuscular apparatus of the bladder and/or its outlet (the urethra). These pathophysiologic defects are not overtly manifested outside the lower urinary tract because these patients routinely do not have any apparent neurologic deficits. The fact that S3 neuromodulation can clinically improve these lower urinary tract symptoms would support the notion that the neural regulation of the bladder is somehow altered in these patients. This paper presents a review of the current knowledge regarding sacral neuromodulation in treatment of non-neurogenic voiding dysfunction.     

Treatment of refractory interstitial cystitis

Interstitial cystitis is the most therapeutically frustrating condition of the urinary tract. The vast array of treatments available clearly indicates that none is particularly effective. As the majority of patients fail to experience a significant and prolonged response to standard treatments, new options are frequently being developed. These include the oral administration of cimetidine, the intravesical use of hyaluronic acid and BCG, and total cystectomy with the formation of a continent urinary diversion. Unfortunately, the acceptance of many new treatments is based on incomplete evaluation, and this has resulted in a confusing array of disparate alternatives. Effective and durable treatment will not be available until the nature of the disease is better understood and the mechanisms of action of current therapies are elucidated.     

Sacral nerve stimulation for pain relief in interstitial cystitis

A 60-year-old woman was treated for severe interstitial cystitis pain using sacral nerve stimulation. Pain and accompanying bladder dysfunction were improved by temporary and permanent sacral nerve stimulation. Six months after implantation of a sacral neuromodulator the patient is pain free and significantly improved on bladder dysfunction. Interstitial cystitis may be an indication for functional electrostimulation.     

Sacral neuromodulation for refractory lower urinary tract dysfunction: results of a nationwide registry in Switzerland

OBJECTIVE: To assess the efficacy and safety of sacral neuromodulation (SNM) in patients with refractory lower urinary tract dysfunction in Switzerland based on a nationwide registry. PATIENTS AND METHODS: A total of 209 patients (181 females, 28 males) underwent SNM testing between July 2000 and December 2005 in Switzerland. Subjective symptom improvement, bladder/pain diary variables, adverse events, and their management were prospectively registered. RESULTS: SNM testing was successful (defined as improvement of more than 50% in bladder/pain diary variables) in 102 of 209 patients (49%). An implantable pulse generator (IPG) was placed in 91 patients (89% of all successfully tested and 44% of all tested patients). Of the IPG-implanted patients, 71 had urge incontinence, 13 nonobstructive chronic urinary retention, and 7 chronic pelvic pain syndrome. After a median follow-up of 24 mo, SNM was successful in 64 of the 91 IPG-implanted patients (70%) but failed in 27 patients. SNM was continued in 15 of the 27 patients considered failures, because following troubleshooting SNM response improved subjectively and the patients were satisfied. However, improvement in bladder/pain diary variables remained less than 50%. In the other 12 patients both the leads and the IPG were explanted. During the test phase and during/following IPG implantation, 6% (12 of 209) and 11% (10 of 91) adverse event rates and 1% (3 of 209) and 7% (6 of 91) surgical revision rates were reported, respectively. CONCLUSIONS: SNM is an effective and safe treatment for refractory lower urinary tract dysfunction. Adverse events are usually transient and can be treated effectively.     

Minimum 6-year outcomes for interstitial cystitis treated with sacral neuromodulation

Introduction and hypothesis  

Interstitial cystitis is a multifaceted medical condition consisting of pelvic pain, urgency, and frequency. Can sacral neuromodulation be successfully utilized for the medium term of ≥6 years in interstitial cystitis patients for whom standard drug therapies have failed?