Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.

AIMS: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up. METHODS: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapy-related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. RESULTS: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3- and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow-up in UUI episodes/day was -3.6 (95% CI: -4.7, -2.6; n = 62) at 3-month and -3.7 (95% CI: -4.7, -2.7; n = 61) at 6-month. Among subjects with urgency-frequency (UF), the average change from baseline to follow up in voids/day was -4.5 (95% CI: -6.3, -2.7; n = 52) at 3-months and -4.4 (95% CI: -6.0, -2.7; n = 52) at 6-month. The cumulative incidence of device-, procedure-, or therapy- related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. CONCLUSIONS: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.

Surgical repair of pelvic organ prolapse in elderly patients.

PURPOSE OF REVIEW: Epidemiologic data suggests that our population greater than 65 years of age will nearly double. In addition, the incidence of women undergoing surgery for pelvic organ prolapse will rise. Chronologic age does not preclude a woman from undergoing a reconstructive procedure, yet the preoperative assessment should be approached most judiciously with great care to insure patient is maximally medically prepared for surgery. RECENT FINDINGS: Surgical procedures in this review include: the abdominal sacral colpopexy, anterior repair, posterior repair, sacrospinous ligament fixation, uterosacral suspension, and iliococcygeus fixation. The advent of robotic surgery has decreased the perioperative morbidity of several of these procedures. However, the risk of more severe complications does appear higher following robotic procedures, when compared with vaginal procedures. SUMMARY: Intuitively, one would surmise that there is a point where vaginal surgery should be considered as the primary procedure based on age, risk and durability of the surgery - unfortunately that age is not clear. Thus, the proper selection of prevalence of organ prolapse surgery can only be done after careful discussion with the patient and including the patient in the selection process as much as possible.

Mesh Excision: Is Total Mesh Excision Necessary?

Nearly 29% of women will undergo a secondary, repeat operation for pelvic organ prolapse (POP) symptom recurrence following a primary repair, as reported by Abbott et al. (Am J Obstet Gynecol 210:163.e1-163.e1, 2014). In efforts to decrease the rates of failure, graft materials have been utilized to augment transvaginal repairs. Following the success of using polypropylene mesh (PPM) for stress urinary incontinence (SUI), the use of PPM in the transvaginal repair of POP increased. However, in recent years, significant concerns have been raised about the safety of PPM mesh. Complications, some specific to mesh, such as exposures, erosion, dyspareunia, and pelvic pain, have been reported with increased frequency. In the current literature, there is not substantive evidence to suggest that PPM has intrinsic properties that warrant total mesh removal in the absence of complications. There are a number of complications that can occur after transvaginal mesh placement that do warrant surgical intervention after failure of conservative therapy. In aggregate, there are no high-quality controlled studies that clearly demonstrate that total mesh removal is consistently more likely to achieve pain reduction. In the cases of obstruction and erosion, it seems clear that definitive removal of the offending mesh is associated with resolution of symptoms in the majority of cases and reasonable practice. There are a number of complications that can occur with removal of mesh, and patients should be informed of this as they formulate a choice of treatment. We will review these considerations as we examine the clinical question of whether total versus partial removal of mesh is necessary for the resolution of complications following transvaginal mesh placement.

Utility of postoperative laboratory studies after female pelvic reconstructive surgery.

OBJECTIVE: We sought to determine the frequency of laboratory studies after female pelvic reconstructive surgery and the rate of intervention based on the results of these laboratory values at a single institution. STUDY DESIGN: We conducted a retrospective review of all patients undergoing female pelvic reconstructive surgery for pelvic organ prolapse by 5 fellowship-trained pelvic reconstructive surgeons at a single institution from Jan. 1, 2010, through Dec. 31, 2010. Exclusion criteria were outpatient procedures, isolated hysterectomy, and a combined surgery with another surgical team performing a separate procedure. Interventions based on the number of laboratory studies were classified as minor (electrolyte repletion, repeat laboratory tests, initiation of antibiotics) or major (transfusion, delayed discharge). RESULTS: A total of 356 patients were included in the final dataset and 100% of patients had routine postoperative laboratory studies. A total of 8771 laboratory values were obtained with a mean of 25 ± 18 laboratory values (0-133) per patient. One-third of postoperative patients (n = 120) underwent a total of 207 interventions based on abnormal laboratory results. The majority of interventions were minor (96%). Of the 120 patients who had a minor intervention, electrolyte repletion was the most common (78%), followed by repeat blood collection (40%) and initiation of antibiotics (4%). The major intervention rate was 4% (n = 8) and all underwent transfusion. Of the 8 transfused patients, 7 demonstrated clinical instability before transfusion and 1 was transfused based on laboratory values and a significant cardiac history. CONCLUSION: Routine postoperative laboratory studies are not necessary for all patients after female pelvic reconstructive surgery and more judicious use based on clinical findings may limit unnecessary minor interventions.

Treatment of overactive bladder: what is on the horizon?

There is still a need to develop additional effective and well-tolerated therapies for the treatment of overactive bladder (OAB). The purpose of this review is to discuss alternative therapies for idiopathic OAB that employ a unique mechanism of action or offer a novel application of an existing therapy. We performed a comprehensive literature review to identify alternative therapies and potential future treatments for idiopathic OAB. The use of botulinumtoxin for idiopathic OAB is on the rise and FDA approval will likely be granted in the future. New innovations in neuromodulation hold the promise of less invasive and more patient-controlled therapies. A number of novel medications, such as ß-adrenoreceptor agonists, or medications with alternative indications, such as phosphodiesterase inhibitors, have been identified as potential therapies for OAB. In addition, novel drug delivery systems, such as vaginal inserts, are also in development and may provide an attractive mechanism to deliver medications with proven efficacy. While conservative measures such as behavioral modification and pelvic floor exercises remain first-line therapy for OAB, anti-muscarinics are the mainstay of medical treatment. For patients with idiopathic OAB refractory to traditional first-line therapies, a number of promising new treatments are on the horizon.

Urodynamics: examining the current role of UDS testing. What is the role of urodynamic testing in light of recent AUA urodynamics and overactive bladder guidelines and the VALUE study?

Urodynamics testing is a diagnostic assessment of the lower urinary tract system composed of multiple tests to obtain physiologic data regarding lower urinary tract function (detrusor and outlet) during storage and emptying. The necessity of urodynamics has been both supported and challenged in various urologic conditions such as urinary incontinence, neurogenic bladder, lower urinary tract symptoms, and bladder outlet obstruction. This review discusses the most recent studies with regards to the utility of urodynamics in current practice, highlighting the recent American Urologic Association Adult Urodynamics and Overactive Bladder Guidelines and the Value of Urodynamic Evaluation study.

Selective management of the urethra at time of pelvic organ prolapse repair: an assessment of postoperative incontinence and patient satisfaction.

PURPOSE: Management of the urethra in women without stress urinary incontinence during pelvic organ prolapse repair can be approached selectively or with a prophylactic suburethral sling. We report on patient satisfaction and outcomes in patients who underwent selective urethral management during pelvic organ prolapse repair. MATERIALS AND METHODS: Patients undergoing repair of advanced apical and/or anterior compartment pelvic organ prolapse underwent prolapse reduction to screen for stress urinary incontinence. Patients with clinical, occult and urodynamic stress urinary incontinence underwent a sling procedure. Those without stress urinary incontinence did not undergo sling surgery. Patients completed responses to the UDI-6 (Urogenital Distress Inventory, PGI-I (Patient Global Impression of Improvement) and MESA (Medical, Epidemiological, and Social Aspects of Aging). Cost analysis of selective urethral management was completed. RESULTS: A total of 42 patients met the study inclusion criteria and 30 completed responses to all questionnaires. Patients were separated into prolapse repair only (14) and prolapse repair with sling (16) groups. In the prolapse repair only group 1 patient required a subsequent sling. Mean UDI-6, MESA urge and MESA stress scores were 3.71, 1.29 and 3.14 in the prolapse repair only group, and 2.31 (p=0.219), 2.69 (p=0.244) and 3.00 (p=0.918) in the prolapse repair with sling group, respectively. The PGI-I revealed no statistical difference between the groups. A total cost savings of $55,804 was achieved using selective urethral management. CONCLUSIONS: Patients undergoing prolapse repair only have continence and satisfaction outcomes that appear equivalent to those who underwent concomitant prolapse repair and sling. The decision to perform a concomitant sling at the time of prolapse repair should be tailored to the patient.

Pro: the contemporary use of transvaginal mesh in surgery for pelvic organ prolapse.

PURPOSE OF REVIEW: This review will focus on the strengths of transvaginal mesh-augmented repairs over traditional native tissue repairs with an emphasis on the more recent literature. RECENT FINDINGS: Recent attention from the Food and Drug Administration has prompted a re-evaluation of the use of commercial mesh kits in pelvic organ prolapse (POP) repair. Mesh kits for POP repair were recently reclassified from Class 2 medical devices to Class 3 medical devices, a policy change that will prompt additional trials for POP repair in the future. The statements published by the FDA and the reclassification of mesh kits have generated a debate regarding the use of mesh in POP repairs. SUMMARY: Higher complication rates involving mesh exposures have been documented in the past leading to the recent controversy; however, current mesh studies with longer term follow-up show lower and acceptable exposures with improved objective and subjective outcomes.

Magnetic resonance imaging following InterStim®: an institutional experience with imaging safety and patient satisfaction.

AIMS: We retrospectively assessed patient safety and satisfaction after magnetic resonance imaging (MRI) in patients with an InterStim® unit. METHODS: The records of all patients implanted with InterStim® between 1998 and 2006 were reviewed. Nine of these patients underwent MRI following InterStim® implantation. The patients' neurologists requested the MRI exams for medical reasons. Both 0.6 Tesla (T) and 1.5 T machines were used. Patient safety, interference of implanted pulse generator (IPG) with radiological interpretation, and patient satisfaction were assessed in these patients. RESULTS: The first patient in the series had IPG failure following MRI. For this patient, the voltage amplitude was set to zero, the IPG was turned off, and the IPG magnetic switch was left on. The patient underwent MRI uneventfully; however, the IPG did not function upon reprogramming. The IPG magnetic switch was turned off for the eight subsequent patients, all of whom underwent MRI safely. In addition, all of their IPGs functioned appropriately following reprogramming. Of the 15 MRIs performed, the lumbar spine was imaged in eight studies, the pelvis was imaged in one study, and the remaining examinations involved imaging the brain or cervical spine. Neither the IPG nor the sacral leads interfered with MRI interpretation. None of the eight patients perceived a change in perception or satisfaction following MRI. CONCLUSIONS: Although we don't advocate the routine use of MRI following InterStim® implantation, our experience suggests MRI may be feasible under controlled conditions and without adverse events.

Outcomes of Midurethral Slings in Women with Concomitant Preoperative Severe Lower Urinary Tract Voiding Symptoms.

BACKGROUND: Women with stress urinary incontinence and concomitant obstructive (voiding) lower urinary tract symptoms (LUTS) represent a challenging patient population. Furthermore, their diagnosis and management remain incompletely studied and controversial. We evaluated the outcomes of midurethral sling procedures in women with severe obstructive LUTS. METHODS: We performed a post hoc analysis of women who were part of an institutional review board-approved study of midurethral sling surgery. Preoperatively and at 4-6 weeks postoperatively, patients completed the American Urological Association Symptom Score (AUASS) questionnaire. A postvoid residual urine test was obtained preoperatively, at the time of the voiding trial, and 4-6 weeks postoperatively. Three groups of patients with severe LUTS were then defined: Group A (AUASS ≥20), Group B (voiding subscale ≥12), and Group C (urodynamic obstruction). Patients could be included in more than one group. AUASS was again obtained at a medium-term follow-up of 31.6 months. RESULTS: Of 106 women completing follow-up, 30, 23, and 11 subjects met the criteria for groups A, B, and C, respectively. All had statistically significant improvements in storage and voiding subscales, as well as their stress urinary incontinence. No subject presented with retention or voiding dysfunction at follow-up. These improvements continued at medium-term follow-up with the exception of Group C that failed to demonstrate persistence of statistical improvement in AUASS subscales. CONCLUSION: Patients with stress urinary incontinence and severe voiding LUTS can be treated safely with midurethral sling procedures. In both the short and medium term, these symptoms improve dramatically in the majority of patients.

Mid-urethral slings in female incontinence: Current status.

The advent of the mid-urethral sling (MUS) 15 years ago has drastically changed the surgical management of stress urinary incontinence (SUI). Both retropubic and transobturator MUS can be placed in the ambulatory setting with excellent results. The tension-free vaginal tape (TVT) sling has the most robust and long-term data, but more recent literature suggests that the transobturator tape sling may offer comparable efficacy in appropriately selected patients. Single incision sling (SIS) is the newest addition to the MUS group and was developed in an attempt to minimize morbidity and create an anti-incontinence procedure that could be performed in the office. The efficacy of SIS remains unknown as the current literature regarding SIS lacks long-term results and comparative trials. The suprapubic arc sling appears to have equally effective outcomes in at least the short-term when compared with TVT. Although evolution of the SIS has led to a less invasive procedure with decreased post-op pain and reduced recovery time, durability of efficacy could be the endpoint we are sacrificing. Until longer-term data and more quality comparison trials are available, tailoring one's choice of MUS to the individual patient and her unique clinical parameters remains the best option.