Sexual response in patients treated with sacral neuromodulation for lower urinary tract symptoms or fecal incontinence.

OBJECTIVES: To determine whether sacral neuromodulation (SNM) for urinary symptoms or fecal incontinence gives improvement of female sexual function and whether improvement is due to physiological or psychological factors. METHODS: Between 2002 and 2008, 8 patients had an array of questionnaires before and after SNM implantation. The questionnaires were: the Questionnaire for Screening for Sexual Dysfunctions, the Golombok Rust Inventory of Sexual Satisfaction, the Symptom Checklist-90, the Maudsley Marital Questionnaire and the McGill-Mah Orgasm Questionnaire. Three of these 8 patients underwent vaginal plethysmography before and after implantation. RESULTS: No statistically significant changes were found, although there seems to be a trend toward improvement in orgasm scores. In plethysmography all 3 patients showed increased vaginal pulse amplitude with the stimulator turned on with both erotic and non-erotic stimuli. CONCLUSIONS: This study does not show a clear effect of SNM on sexual function, although there seems to be an improvement in orgasm scores. The lack of response on psychological questionnaires and the increase in vaginal pulse amplitude after SNM implantation indicate that there might be a physiological response.

Sacral nerve modulation for defaecation and micturition disorders in patients with spina bifida.

AIM: Sacral nerve modulation is a well accepted method for the treatment of defaecation disorders and voiding dysfunction. Results of sacral nerve modulation in patients with spinal cord lesions are not well assessed, but preliminary results look poor. Therefore, the purpose of this study was to assess the effectiveness of sacral nerve modulation for defaecation disorders and voiding dysfunction in patients with spina bifida. METHOD: Consecutive patients with spina bifida suffering from a myelomeningocele and combined faecal and urinary functional disorders that were eligible for peripheral nerve evaluation (PNE) were studied. A permanent sacral nerve modulation implantation was performed after successful PNE. RESULTS: Ten patients (four female) were included in this study with a median age of 26.4 (range 11.1-41.0) years. In two the PNE was not possible. The median faecal incontinence days (6.0 vs 3.5) and episodes (8.5 vs 3.5) per 21 days decreased significantly during the 3-week period of PNE (P = 0.033). Only 3/10 (30%) patients had a more than 50% improvement and proceeded to a permanent sacral nerve modulation implantation. In one patient it was not possible to perform the permanent implant. CONCLUSION: Preliminary results of sacral nerve modulation in a subgroup of spina bifida patients with combined faecal and urinary functional disorders look promising, but long-term results in larger patient groups need to be studied.

Long term results of neuromodulation by sacral nerve stimulation for lower urinary tract symptoms: a retrospective single center study.

OBJECTIVE: To analyse the influence of technical improvements of Sacral Nerve Stimulation (SNS) on the incidence of surgical interventions and subjective long-term results of SNS. METHODS: Retrospective, transversal study analyzing records of implanted patients at our department of Urology. RESULTS: Of 149 patients analyzed, 107 had overactive bladder symptoms and 42 had urinary retention. Mean follow-up was 64,2 (sd = 38,5) months. In the whole group 194 adverse events occurred. 6 Patients had infection in their implanted system, one was explanted for infection. Most events could be solved by giving advice or by reprogramming the stimulator. 129 reoperations have been performed and 21 patients had their system explanted. Analysis of the data shows a striking difference in the incidence of reoperations, but small differences in subjective results in the groups of patients implanted before or after 1996, suggesting that a proactive approach towards adverse events is worthwhile. CONCLUSIONS: SNS gives lasting benefit in patients with refractory symptoms of overactive bladder and non-obstructive urinary retention. The differences in outcomes and incidence of reoperation can be attributed to the learning curve and technical and surgical improvements in the application of SNS.

European experience with bilateral sacral neuromodulation in patients with chronic lower urinary tract dysfunction.

Although there is experimental and clinical evidence that bilateral stimulation of the sacral nerves could lead to summation effects, no significant differences in unilateral versus bilateral neuromodulation could be demonstrated in a comparative trial. In some individuals, however, only bilateral stimulation relieved symptoms. Therefore, if a unilateral percutaneous nerve evaluation test fails, a bilateral test should be considered. Further clinical research with long-term follow-up will allow the identification of which patients could benefit from bilateral stimulation with greater specificity and ameliorate further the long-term results achieved with unilateral SNS.

Urodynamic results of sacral neuromodulation correlate with subjective improvement in patients with an overactive bladder.

OBJECTIVES: Standard urodynamic investigations showed no correlation between the efficacy of sacral neuromodulation (SNS) and urodynamic data. Ambulant urodynamic investigations (ACM) are presented as more sensitive and reliable in detecting and quantifying bladder overactivity. In this study we looked at the correlation and results of ambulant urodynamic data and the clinical effects of SNS. METHODS: Data of patients with bladder overactivity, who underwent an ACM before and during SNS were investigated. Blind analyses of the ACM were performed and the detrusor activity index (DAI) was calculated as the degree of bladder overactivity of the detrusor. The ACM parameters, before and during SNS, were analyzed and correlated to the clinical effect of SNS. RESULTS: In 22 of the 34 patients a DAI before and during stimulation could be calculated because of quality aspects. In all other patients, the other ambulatory urodynamic parameters could be analyzed and a significant reduction was found in bladder overactivity. A significant correlation (p = 0.03) was found in DAI reduction of the ACM before and during SNS as compared to the clinical improvement in overactive bladder symptoms. CONCLUSIONS: The objective and subjective results show a decrease in bladder overactivity during SNS. During SNS bladder instabilities are still present, which is in accordance with the published literature. The reduction of the DAI during SNS as compared to before SNS correlates significantly to the clinical effect of SNS.

Long-term efficacy and safety results of the two-stage implantation technique in sacral neuromodulation.

OBJECTIVE: To assess the long-term efficacy and safety of two-stage sacral neuromodulation with an implantable pulse generator (IPG) in patients treated for urinary urge incontinence (UI) and/or urinary retention (UR). PATIENTS AND METHODS: The two-stage technique is used if patients have a good response during the acute phase of the percutaneous nerve evaluation (PNE) test, but have a poor response during the following 4-7 days (subchronic phase). In the first stage only the permanent electrode was implanted and connected to a temporary external stimulator, allowing patients to be assessed for longer. If the main symptoms improved by more than half the patient proceeded to the second stage, the insertion of the IPG. We reviewed all patients who underwent two-stage implantation; all had signed an informed consent and were asked to complete voiding diaries and a questionnaire to assess the subjective effects of the therapy. Safety was assessed from relevant medical events, management, and relative to the thera-py and resolution. Residual urine was assessed by self-catheterization. The long-term voiding diary results were compared with baseline estimates and analysed statistically using the two-sided Student's t-test. RESULTS: Between 1991 and 1998, 15 patients (13 women and two men, mean age 53 years, range 44-66) underwent the two-stage technique; the mean (median, range) follow-up was 4.9 (5.2, 2.5-7.5) years. Seven patients had UI and seven had UR, with one having both. The mean (range) number of PNEs undertaken in each patient was 2.1 (1-4) and these all failed in the subchronic phase. All patients underwent a first- and second-stage implant after a mean (range) screening period of 12.2 (2-29) days. One patient was explanted after implantation of only the first stage, and two others explanted in a later phase because the IPG was ineffective during the follow-up. The voiding diary results of the remaining 12 patients showed improvement in all the main variables, and in the subjective assessment 11 reported an improvement and were satisfied with the therapy. There were 17 adverse events, 14 of which were resolved and seven of which required surgical intervention. CONCLUSION: The long-term results of the two-stage implantation show clinically and statistically significant improvements, probably because the implantation of the lead (first stage) more closely resembles the final therapy. If a temporary PNE test is not optimal (lead migration, longer testing needed), the two-stage technique can offer a good and safe alternative of comparable efficacy in the long-term. If the two-stage technique had not been available to these 12 patients they would not have been offered neuromodulation.

Predictive factors for sacral neuromodulation in chronic lower urinary tract dysfunction.

OBJECTIVES: To investigate data from 211 patients who underwent a trial stimulation (percutaneous nerve evaluation [PNE]) to determine the clinical parameters that can enhance the prediction of PNE success. The advantageous effect of sacral neuromodulation depends on the accurate identification of suitable candidates during the preimplantation PNE. METHODS: A total of 211 patients (161 women and 50 men), with refractory urge incontinence, urgency-frequency syndrome, and urinary retention, underwent a PNE. Patient data (demographics, medical history, urologic investigations, and diagnosis) were collected. The PNE results were evaluated from a voiding diary and patient history. More than 50% improvement of voiding parameters was considered a successful PNE, and those patients were selected for implantation. Logistic regression analysis was performed. The factors tested for predicting the test result were sex, patient age, diagnosis, previous surgery, neurogenic bladder dysfunction, duration of complaints, and previous treatments. RESULTS: The PNEs were positive in 85 patients (40.3%) and negative in 105 patients (49.8%). In 18 patients (8.5%), the test electrode had migrated; 3 more patients were not assessable and were also excluded. Missing data on the variable "duration of complaints" reduced the number of patients in the analyses from 190 to 174 patients. CONCLUSIONS: Intervertebral disk prolapse, duration of complaints, neurogenic bladder dysfunction, and urge incontinence were found to be significant predictive factors. However, a PNE remains necessary to evaluate a patient's chance of implant success objectively.

Unilateral versus bilateral sacral neuromodulation in patients with chronic voiding dysfunction.

PURPOSE: Bilateral sacral nerve neuromodulation has been proposed as a more effective treatment for chronic voiding dysfunction. However no comparison with the unilateral approach has been performed. We investigated the possible advantage of bilateral sacral neuromodulation. MATERIALS AND METHODS: In a prospective randomized crossover trial we investigated 33 patients who underwent bilateral implantation of a temporary test lead. Unilateral and bilateral test stimulation was continued for 4 to 6 days in all patients. Patients were randomly assigned to start with bilateral or unilateral stimulation. Between the stimulation episodes a 2-day washout interval was scheduled. Voiding diaries were completed at baseline and during the entire stimulation period. Sacral x-rays were taken to confirm lead positioning or possible migration after implantation and at the end of the test stimulation period. After 10 days the temporary leads were removed and voiding diaries were analyzed. RESULTS: After stimulation sacral x-ray revealed test lead migration in 8 patients, leaving 12 patients with urge incontinence and 13 with voiding difficulty and urinary retention available for review. A statistically significant improvement in voiding parameters was seen during the test stimulation period. However no statistically significant improvement was seen due to bilateral stimulation compared to unilateral stimulation. Two patients with urinary retention only started voiding to completion during bilateral stimulation. CONCLUSIONS: Bilateral is in general not superior to unilateral sacral neuromodulation. However, in some individuals bilateral stimulation may be more effective in relieving symptoms. Therefore, if unilateral percutaneous nerve evaluation fails, a bilateral test should be considered.

Buttock placement of the implantable pulse generator: a new implantation technique for sacral neuromodulation--a multicenter study.

OBJECTIVE: In the standard operation procedure for sacral neuromodulation, the implantable pulse generator (IPG) is implanted in a subcutaneous pocket at the lower part of the anterior abdominal wall. This procedure requires a long operation time and three incisions. With the IPG in the abdominal wall, some patients complain of displacement or pain at the IPG site postoperatively. By modifying the technique of placement of the IPG, these disadvantages are overcome. METHODS: Between August 1999 and July 2000, 39 patients underwent a buttock implant of the IPG. In 2 of these patients the position of the IPG was changed from abdominal region to the buttock. During follow-up, complications concerning the operation and location of the IPG were compared to the published literature. RESULTS: Operation time is reduced in all patients by approximately 1 h. No repositioning of the patient is required during surgery. Only a short subcutaneous tunnel is required to connect the lead to the IPG. Pain at the level of the IPG was noted in 10% of the patients, which needed no further treatment. No infections were seen and the IPG did not displace postoperatively. CONCLUSION: Buttock placement of the IPG in sacral nerve stimulation leads to shorter operation time; only two incisions are needed instead of three and a shorter subcutaneous tunnel is needed. Using this technique there are less complications and a lower re-operation rate.

Novel test lead designs for sacral nerve stimulation: improved passive fixation in an animal model.

PURPOSE: To evaluate the ability of two novel coiled test stimulation lead designs to reduce or eliminate undesired migration and concomitant loss or attenuation of responsiveness to sacral nerve stimulation (SNS) associated with standard percutaneous nerve evaluation (PNE) leads. MATERIALS AND METHODS: The two novel leads (Coiled Leads 1 and 2) and a standard PNE lead were inserted bilaterally in sacral foramina of female goats. At various times thereafter threshold voltage responses were measured. Prior to lead removal, distance of lead migration was evaluated by x-ray imaging and the force necessary to displace the leads measured. Thereafter, as the leads were being removed, the force necessary for removal was also measured. RESULTS: Migration was consistently either nil or minimal for both coiled leads. In contrast, migration of the standard lead occurred in all cases and was substantial in magnitude. A significant linear association was evident between the migration distance of the standard lead and the corresponding voltages needed to evoke a response. The forces necessary to displace Coiled Lead 1 and Coiled Lead 2 were both significantly higher (p <0.01) than those for the standard lead. In some cases comparatively high forces were needed for removal of Coiled Lead 1 but not Coiled Lead 2. CONCLUSIONS: Coiled lead designs appear to offer a potentially promising alternative to standard leads for PNE, allowing a wider range of patients to be correctly identified as candidates for sacral root neuromodulation. Coiled Lead 2 merits further investigation in human subjects.

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.

Clinical results of sacral neuromodulation for chronic voiding dysfunction using unilateral sacral foramen electrodes.

The aim of this study was to determine the long-term clinical efficacy and complications of neuromodulation with a unilateral sacral foramen electrode in 36 patients with chronic voiding dysfunction. Following a positive effect of a percutaneous nerve evaluation test, patients underwent open surgery. A permanent electrode was implanted in 24 patients with urge incontinence, in 6 with urgency-frequency syndrome, and in 6 with nonobstructive urinary retention. After an average follow-up period of 37.8 months, 19 patients (52.8%) continue to benefit from the neuromodulation with a significant improvement of symptoms and urodynamic parameters. The median duration of the therapeutic effect for the total study population was longer than 60 months. No significant difference in the median duration of therapeutic effect with regard to sex, the type of voiding disorder, or the implant pulse generator was found. However, in patients with previous psychological disorders the median duration of therapeutic effect was only 12 months (P = 0.008). Complications were mild. In the group of patients in whom the therapeutic effect remains, 37 reoperations have had to be performed. We conclude that although reoperations were needed to overcome technical problems, patients can achieve lasting symptomatic improvement. Since technical changes in the equipment have reduced the number of complications, even better results can be expected in terms of the reoperation rate.

Randomized double-blind placebo-controlled multicenter evaluation of efficacy and dose finding of midodrine hydrochloride in women with mild to moderate stress urinary incontinence: a phase II study.

Midodrine is a potent and selective alpha1-receptor agonist and its potential to increase urethral closure pressure could be useful in the treatment of female stress incontinence. The aim of this randomized double-blind placebo-controlled multicenter study was to evaluate the efficacy and safety of midodrine for the treatment of stress urinary incontinence. The primary criterion of efficacy was the maximum urethral closure pressure at rest. Voiding diaries, symptom and incontinence questionnaires and patient/investigator global assessment were also used to evaluate its efficacy. After 4 weeks of treatment no significant changes in MUCP were found. The global assessment by the patient and investigator did indicate that patients on active treatment had a more positive assessment than the placebo group. In conclusion, midodrine did not cause significant improvements in urodynamic parameters, but there were subjective improvements in some of the patients in the treated groups. Furthermore midodrine was well tolerated.

Improving neuromodulation technique for refractory voiding dysfunctions: two-stage implant.

OBJECTIVES: Neuromodulation is a new technique that uses electrical stimulation of the sacral nerves for patients with refractory urinary urge/frequency or urge-incontinence, and some forms of urinary retention. The limiting factor for receiving an implant is often a failure of the percutaneous nerve evaluation (PNE) test. Present publications mention only about a 50% success score for PNE of all patients, although the micturition diaries and urodynamic parameters are similar. We wanted to investigate whether PNE results improved by using a permanent electrode as a PNE test. This would show that improvement of the PNE technique is feasible. METHODS: In 10 patients where the original PNE had failed to improve the micturition diary parameters more than 50%, a permanent electrode was implanted by operation. It was connected to an external stimulator. In those cases where the patients improved according to their micturition diary by more than 50% during a period of 4 days, the external stimulator was replaced by a permanent subcutaneous neurostimulator. RESULTS: Eight of the 10 patients had a good to very good result (60% to 90% improvement) during the testing period and received their implant 5 to 14 days after the first stage. CONCLUSIONS: The good results of the two-stage implant technique we used indicate that the development of better PNE electrodes may lead to an improvement of the testing technique and better selection between nonresponders and technical failures.

Efficacy of biofeedback, when included with pelvic floor muscle exercise treatment, for genuine stress incontinence.

UNLABELLED: We performed a randomized clinical trial on the efficacy of physical therapy on genuine stress incontinence. STUDY OBJECTIVE: "Is a physical therapeutical training program (pelvic floor muscle training) combined with biofeedback, more effective than the same program without biofeedback in patients with mild or moderate stress incontinence?" Forty-four patients were referred by a general practitioner or a urologist. After informed consent, 40 patients were randomized in an exercises and biofeedback group (BF), or treated with exercises exclusively (pelvic floor muscle training = PFMT). After a diagnostic phase of 1 week every patient received twelve treatment sessions, three times weekly. The primary measure of effect, the quantity of involuntary urine loss, was measured with the 48 hours PAD test (Inco-test Mölnlycke). Before every treatment session the Symptoms questionnaire was filed out by the patient and the Patient dairy was controlled. The data of the trial were analysed according to the principal of intention to treat. During the trial there was 100% compliance. There were no drop-outs. Both treatment modalities appeared to be effective. After twelve treatment sessions there was a mean improvement of +/- 55% (P = 0.00) in both treatment groups, measured by the primary measure of effect. In the group with BF this improvement was already realized after six treatment sessions (P = 0.01). Yet, the difference between BF and PFMT faded to reach significance at six treatment sessions (P = 0.08). Although differences in treatment effects between both groups were not significant, our findings suggest that adding biofeedback to pelvic floor muscle exercises might be more effective than pelvic floor muscle exercises alone after six treatments.

Electrically stimulated gracilis sphincter (dynamic graciloplasty) for treatment of intrinsic sphincter deficiency: a pilot study on feasibility and side effects.

PURPOSE: The feasibility and side effects of electrically stimulated gracilis sphincter (dynamic graciloplasty) were studied in 7 patients with severe incontinence due to intrinsic sphincter deficiency. MATERIALS AND METHODS: The distal part of the gracilis muscle is wrapped around the bladder neck. Afterwards, 2 muscle electrodes and a programmable pulse stimulator are implanted. During a stimulation program the fatigable type 2 skeletal fibers are replaced by slow type 1 fibers, which are able to sustain a long lasting contraction. RESULTS: Among the patients 3 are continent, 1 is partially continent and treatment failed in 3. CONCLUSIONS: The results are encouraging. Dynamic graciloplasty may have a role in the treatment of intrinsic sphincter deficiency.

Papillary mesothelioma of the albuginea testis.

An eleven-year-old boy is presented with symptom of a torsion of the testis. Scrotal exploration revealed a papillary mesothelioma of the tunica albuginea which is extremely rare in childhood. We report 1 case and review the literature.