Ernest Weil

Medium‐term experience of sacral neuromodulation by tined lead implantation

To describe patient selection for sacral neuromodulation, also known as Interstim therapy, and the results of tined‐lead implantation in the medium term.

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).

Long-term therapy with a depot luteinizing hormone-releasing hormone analogue (Zoladex) in patients with advanced prostatic carcinoma.

We treated 191 patients with histologically proved locally advanced stage (T3 or T4) and/or metastatic prostate cancer with a biodegradable depot formulation of a luteinizing hormone-releasing hormone analogue (Zoladex). After an initial increase in serum testosterone in week 1 of therapy a continuous decrease of testosterone to castrate levels was obtained. With a monthly injection of the luteinizing hormone-releasing hormone analogue 4 patients (2 per cent) experienced a transient increase in bone pain, 1 had ureteral obstruction and 1 suffered paraplegia during the first few weeks of therapy. Over-all objective and subjective responses were similar to those obtained by castration or estrogen therapy. The absence of local and systemic (long-term) side effects proves the validity of this approach for patients with advanced prostatic cancer.

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.

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.

Transvaginal ultrasonography: a study with healthy volunteers and women with genuine stress incontinence.

In order to distinguish different types of stress urinary incontinence with the help of urodynamics combined with ultrasound, a study was executed to find out if and how ultrasonographic variables in stress incontinent patients differ from healthy women. Various quantitative variables were defined and compared in the aforementioned groups. Craniocaudal and ventrodorsal related variables were the most discriminative in rest position. During coughing the same directional variables were also discriminative. The difference between stress and rest was significant only for the craniocaudal direction. The often discussed posterior vesical angle had no predictive value. The results of this pilot study support the concept that anatomical differences between stress incontinent patients and healthy women can be detected ultrasonographically. The study further indicates that stress urinary incontinence can be caused by a low rest position of the bladder neck or by a hypermobile bladder neck. Urodynamics combined with ultrasound probably can be applied to distinguish more precisely different types of stress urinary incontinence.

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.

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.

Is on-demand sacral neuromodulation in patients with OAB syndrome a feasible therapy regime?†‡

Sacral neuromodulation (SNM) of the lower urinary tract has proven to be safe and effective in patients with complaints of OAB syndrome who are not responding to conservative therapy. After 5 years of treatment the implanted system is still effective in 56–71% of patients. The loss of effect could be caused by adaptation of the nerve system to prolonged stimulation of the sacral nerves.

Tined Lead Implantation: Results of the First 37 Implants in Maastricht

Since its introduction in the early 1990s sacral neuromodulation is applied in patients with refractory urge incontinence, urgency-frequency, and nonobstructive urinary retention (1–4). Usually potential candidates are tested with a temporary lead before the implantation of a permanent neuromodulation system is considered. Clinical experience with the test procedure for neuromodulation showed that the temporary lead is prone to migration during the test phase. Due to this fact and because of the probability of infections in temporary leads that are in situ for a long time, the duration of the test phase is limited to a maximum of about 1 week. Moreover, some patients have different results with the temporary lead and the permanent implant. In 2003 Spinelli et al. introduced a new minimally invasive method for the implantation of a permanent lead (5,6), allowing a prolonged duration of the test phase. Moreover, the lead can easily be removed if the test results are insufficient. In this article we describe our first experiences with the new lead according to this minimally invasive procedure. Methods