Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT™.

AIMS: This paper presents 4-year follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). METHODS: The clinical study involved 11 clinical sites and enrolled 160 subjects, all male. A total of 124 subjects met study criteria and 123 were implanted with ProACT. Baseline and outcomes for 68 patients who completed 4-year follow-up visits are reported. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and incidence and severity of device or procedure-related adverse events. RESULTS: Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the mean pre-implant urine loss was 293 g, which was reduced at 4 years to 73 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad use. One procedure-related SAE (retention) was reported among the 68 subjects; the SAE was resolved without clinical meaningful sequalae. CONCLUSIONS: These results confirm the long-term safety and efficacy of this newly FDA-approved therapy, showing significant improvements in both objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The implant procedure is minimally invasive, and complications are generally mild and easily resolvable.

Treatment with an adjustable long-term implant for post-prostatectomy stress incontinence: The ProACT™ pivotal trial.

AIMS: This paper presents 18-month follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The trial evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). METHODS: The clinical study involved 11 clinical sites and enrolled 160 subjects. A total of 124 subjects met study criteria and 123 underwent ProACT implantation from July 2005 through June 2007, of whom 98 completed 18-month follow-up. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and device or procedure-related adverse events (AEs). RESULTS: The mean surgical time was 32 min. Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the cohort mean pre-implant urine loss was 399 g, which was reduced at 18 months to 160 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad count. One procedure-related serious adverse event (SAE), retention, was reported among the 124 subjects; the SAE was resolved without clinical meaningful sequalae. CONCLUSIONS: These results demonstrate the safety and efficacy of this newly FDA-approved therapy, showing significant improvements in objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients. The duration of the implant procedure is short, and complications are mild and easily resolvable.

Algorithm-based multidisciplinary treatment approach for rectourethral fistula.

PURPOSE: The purpose of this study is to report the outcomes of an algorithm-based multidisciplinary treatment approach to rectourethral fistula. METHODS: This study is a retrospective review of a prospectively collected database at a tertiary center of all consecutive patients treated between 2003 and 2013. RESULTS: Thirty males (mean age 63 years) were reviewed. Prostate cancer treatment was the most common fistula etiology (97%). Urinary drainage consisted of urethral catheter in all patients and suprapubic catheter in 14 (47%). The rate of fecal diversion was 67%. During a mean follow-up of 72 months, healing rate was 90% and recurrence rate 0%. Spontaneous healing was achieved in 14 patients (47%): 8 (27%) without fecal diversion and 6 (20%) following fecal diversion. Thirteen patients (43%) required definitive intervention. The majority of operated patients underwent transanal or transperineal flap (endorectal, dartos, or gracilis) successfully. Only 2 patients (7%) required an abdominal approach (positive oncologic margins or non-functioning bladder). Fifteen out of the 20 patients (75%) who underwent fecal diversion had stoma closure with an overall permanent stoma rate of 17%. Long-term urinary incontinence was noted in 11 patients (37%). Six patients (20%) required permanent urinary diversion or drainage catheters. CONCLUSIONS: Algorithm-based treatment approach for rectourethral fistula is useful in the management of this rare condition. Selective fecal diversion is possible, and majority of patients who require definitive intervention can be treated with a transanal or transperineal approach. The rate of permanent stoma is low, but long-term urinary dysfunction is frequent.

Treatment of moderate to severe female stress urinary incontinence with the adjustable continence therapy (ACT) device after failed surgical repair.

INTRODUCTION: Treatment of recurrent stress incontinence after a failed surgical procedure is more complicated, and repeat surgeries have higher rates of complications and limited efficacy. We determined the technical feasibility, efficacy, adjustability, and safety of adjustable continence therapy device for treatment of moderate to severe recurrent urinary incontinence after failed surgical procedure. MATERIALS AND METHODS: Female patients with moderate to severe recurrent stress urinary incontinence who had at least one prior surgical procedure for incontinence were enrolled. All patients underwent percutaneous placement of adjustable continence therapy (ACT) device (Uromedica, Plymouth, Minnesota). Baseline and regular follow-up tests to determine subjective and objective improvement were performed. RESULTS: A total of 89 patients have undergone implantation with 1-3 years of follow-up. Data are available on 77 patients at 1 year. Of the patients, 47% were dry at 1 year and 92% improved after 1-year follow-up. Stamey score improved from 2.25 to 0.94 at 1 year (P < 0.001). IQOL questionnaire scores improved from 33.9 to 71.6 at 1 year (P < 0.001). UDI scores reduced from 60.7 to 33.3 (P < 0.001) at 1 year. IIQ scores reduced from 57.0 to 21.6 (P < 0.001) at 1 year. Diary incontinence episodes per day improved from 8.1 to 3.9 (P < 0.001) at 1 year. Diary pads used per day improved from 4.3 to 1.9 (P < 0.001). Explantation was required in 21.7% of patients. CONCLUSION: The ACT device is an effective, simple, safe, and minimally invasive treatment for moderate to severe recurrent female stress urinary incontinence after failed surgical treatment.

Review of intentionally self-inflicted, accidental and iatrogetic foreign objects in the genitourinary tract.

PURPOSE: Retrospective evaluation of a series of patients presenting with genitourinary foreign objects. PATIENTS AND METHODS: From 1997 to 2007, 11 men and 2 women were treated for a variety of foreign objects in the genitourinary tract. Medical records were reviewed for presentation, diagnosis, mental status, drug dependency, treatment, and follow-up. RESULTS: 13 patients were seen for removal of the foreign objects or for treatment of the sequela. These objects were intentionally self-inflicted, accidentally introduced or iatrogenic in nature. Intentional objects included: safety pins, screwdriver, marbles, pen cap, pencils, straw, cocaine, stiff metal wire and part of a pizza mixer. Accidental objects included: magnets, female catheter, urinary incontinence devices and part of a Foley catheter. The iatrogenic object was a reservoir from an inflatable penile implant. Smaller noninjurious objects were retrieved cystoscopically or at the bedside; larger objects or objects associated with trauma to the urethra needed open and reconstructive operations. CONCLUSIONS: Generally thought to be self-inflicted for personal gratification, the source of genitourinary objects can also be accidental or iatrogenic. The most traumatic injuries are purposely self-inflicted and found in patients who remove the objects themselves. These patients are at higher risk of permanent urethral damage needing complex surgical treatment and follow-up.

Rapid implementation of a robot-assisted prostatectomy program in a large health maintenance organization setting.

PURPOSE: We present the rapid implementation of a robot-assisted surgery program by one of the largest health maintenance organizations (HMOs) in the United States. MATERIALS AND METHODS: A core group of 10 urologists were offered access to a new da Vinci S surgical system. A core group of five ancillary staff was assembled and trained at an Intuitive Surgical-designated training site. An experienced robotic surgeon acted as a proctor. Data regarding patient demographics, preoperative parameters, operative times, pathologic outcomes, and EPIC-26 quality-of-life questionnaires were collected prospectively and reviewed. All procedures were recorded on digital video disc as part of a quality assurance protocol. The core group reviewed complications monthly and received feedback on surgical techniques and pathologic outcomes. RESULTS: A total of 100 robot-assisted laparoscopic radical prostatectomies were performed from August to October 2008. The patient demographics, preoperative parameters, operative times, and pathologic outcomes of these first 100 procedures are outlined. CONCLUSIONS: We demonstrate the rapid implementation of an efficient multisurgeon HMO-based robot-assisted prostatectomy program with promising initial outcomes.

Stress urinary incontinence in women.

Stress urinary incontinence (SUI) is a major health issue that affects millions of patients each year. Traditionally, surgical procedures such as slings or bladder neck suspension were the only options to treat this condition. In recent years, multiple minimally invasive options to treat SUI were introduced into the market. These include bulking agents, injection of stem cells into the rhabdosphincter, and adjustable continence therapy devices. These procedures are simple, minimally invasive, and well tolerated by patients. This article reviews the benefits, efficiency, side effects, and complications of these minimally invasive methods for treatment of SUI.

The adjustable continence therapy system for recurrent female stress urinary incontinence: 1-year results of the North America Clinical Study Group.

PURPOSE: We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence. MATERIALS AND METHODS: Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular followup tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events. RESULTS: A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p <0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p <0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p <0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate. CONCLUSIONS: The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.

Repair of giant vesicovaginal fistulas.

PURPOSE: We evaluated the long-term success rate of an abdominovaginal approach using a rotational bladder flap to repair giant vesicovaginal fistula. MATERIALS AND METHODS: A total of 35 patients were included in this study. Of these patients 28 had a large vesicovaginal fistula and 7 had complete loss of the urethral floor. Fistula etiology was secondary to obstructed labor in 25 patients, the result of iatrogenic surgical injuries in 5, sling erosion in 3 and pelvic irradiation in 2. Using combined abdominal and vaginal approaches the bladder was bisected sagittally, and a bladder flap was rotated downward and medially to fill the extensive fistula defect. An additional vascularized flap was interposed in 23 patients including gracilis muscle flap in 13, omental flap in 5, peritoneal flap in 2 and Martius flap in 3. RESULTS: Fistulas were successfully repaired in 31 of 35 patients (88%). The remaining 4 patients underwent surgical correction with a second, more limited repair. This group included 2 patients with fistula from obstructed labor, 1 due to sling erosion and 1 due to irradiation. CONCLUSIONS: A combined abdominovaginal approach with the use of a generous rotational bladder flap for repair of a complex vesicovaginal fistula allowed for excellent results. There was a high success rate on the first attempt due to the excellent exposure and healthy, well vascularized tissue used for repair.

Management of rectal injuries sustained during laparoscopic radical prostatectomy.

OBJECTIVES: To report on a treatment algorithm for the management of rectal injures. Rectal injuries during laparoscopic radical prostatectomy (LRP) are rare. In the first 200 cases of LRP performed at our institution, 2 (1%) rectal injuries occurred. Our experience prompted collaboration with our colorectal surgery colleagues to develop a treatment algorithm for the management of such injuries. METHODS: We report on the management of rectal injuries sustained during LRP at our institution. We describe the intraoperative laparoscopic repair of a rectal tear using a 2-layer interrupted closure with absorbable suture. The conservative, nonoperative, management of a rectourethral fistula in a patient who presented after LRP is also described. Collaboration with our colorectal surgery colleagues resulted in the formulation of a treatment algorithm for intraoperative and postoperative presentations of rectal injury during LRP. The algorithm is presented. RESULTS: Of the first 200 cases of LRP at our institution 2 (1%) were complicated by rectal injury. Injuries recognized intraoperatively should be managed laparoscopically if the operating surgeon is adept at intracorporeal suturing. Small rectourethral fistulas can be managed conservatively with urinary catheterization or diversion and antibiotics as needed. Rarely, rectal injuries sustained during LRP will require fecal diversion; injuries that fail to heal despite fecal diversion require operative repair. CONCLUSIONS: Rectal injuries incurred during LRP are rare but must be managed successfully to minimize morbidity. Rectal tears recognized intraoperatively can be managed laparoscopically. The development of a rectourethral fistula is a potential complication of LRP. Most fistulas can be managed conservatively with urinary catheterization or diversion. Rarely, rectal injuries that occur during LRP require fecal diversion or definitive operative repair.

A preliminary report on combined penoscrotal and perineal approach for placement of penile prosthesis with corporal fibrosis.

Purpose. This paper aims at describing the combined penoscrotal and perineal approach for placement of penile prosthesis in cases of severe corporal fibrosis and scarring. Materials and methods. Three patients with extensive corporal fibrosis underwent penile prosthesis placement via combined penoscrotal and perineal approach from 1997 to 2006. Follow-up ranged from 15 to 129 months. Results. All patients underwent successful implantation of semirigid penile prosthesis. There were no short- or long-term complications. Conclusions. Results on combined penoscrotal and perineal approach to penile prosthetic surgery in this preliminary series of patients suggest that it is a safe technique and increases the chance of successful outcome in the surgical management of severe corporal fibrosis.

Review of the surgical approaches for Peyronie's disease: corporeal plication and plaque incision with grafting.

The understanding and management of Peyronie's disease (PD) has improved but elucidating the exact etiology of the disease has yet to be achieved. In this paper, we review the historical and clinical aspects of PD. We focus on the evolution of surgical management for PD and review recent published articles that compare popular surgical techniques such as plication and plaque incision with vein graft. These two techniques have been reported to be equivalent with respect to patient satisfaction; however, each technique has its own advantages and disadvantages.

Penile corporeal reconstruction during difficult placement of a penile prosthesis.

For some patients with impotence and concomitant severe tunical/corporeal tissue fibrosis, insertion of a penile prosthesis is the only option to restore erectile function. Closing the tunica over an inflatable penile prosthesis in these patients can be challenging. We review our previous study which included 15 patients with severe corporeal or tunical fibrosis who underwent corporeal reconstruction with autologous rectus fascia to allow placement of an inflatable penile prosthesis. At a mean follow-up of 18 months (range 12 to 64), all patients had a prosthesis that was functioning properly without evidence of separation, herniation, or erosion of the graft. Sexual activity resumed at a mean time of 9 weeks (range 8 to 10). There were no adverse events related to the graft or its harvest. Use of rectus fascia graft for coverage of a tunical defect during a difficult penile prosthesis placement is surgically feasible, safe, and efficacious.

An overview of nocturia and the syndrome of nocturnal polyuria in the elderly.

Nocturia is common in the elderly population and, aside from being a nuisance, it is associated with morbidity and mortality. Nocturia results from the complex interactions of several factors: changes in the urinary system and renal function with aging, the effects of sleep on renal function, changes in sleeping patterns associated with aging, and the presence of concurrent diseases and medications. Nocturia in the elderly can be caused by many conditions; a common cause is the syndrome of nocturnal polyuria. Although the pathophysiology of nocturnal polyuria remains obscure, some investigators believe that low night-time levels of antidiuretic hormone are involved. Proper management of nocturia requires identification of the specific underlying causes. This Review provides an overview of the mechanisms, evaluation and treatment of nocturia for the practicing nephrologist.

Combined endorectal advancement flap with Alloderm graft repair of radiation and cryoablation-induced rectourethral fistula.

Rectourethral fistula is a potentially devastating disease for the patient and difficult management problem for the physician. We report a case of radiation and salvage cryoablation-induced rectourethral fistula for treatment of prostate cancer successfully repaired with a combined endorectal advancement flap with Alloderm graft. The surgical technique is described in detail. The patient is now one year post-repair with no evidence of recurrence.

Subjective patient-reported experiences after surgery for Peyronie's disease: corporeal plication versus plaque incision with vein graft.

OBJECTIVES: To compare patient-perceived outcomes of corporeal plication to plaque incision with saphenous vein grafting for the correction of Peyronie's disease. METHODS: Patients with stable Peyronie's disease deemed to be good operative candidates for both tunical plication and plaque incision with saphenous vein graft were counseled on both procedures and chose which operation they would undergo. At 1 year, the records were reviewed and the patients were contacted. The variables included age, operative time, and outcome ("satisfactorily straight," loss of rigidity, loss of sensation, new use of erectile aids, ability to have intercourse, palpable nodules, erectile pain, penile shortening, and being "completely satisfied"). RESULTS: Of the 67 patients, 35 underwent tunical plication and 32 underwent plaque incision with vein grafting. No differences were present in patient age between the two groups. The average operative time was shorter for the plication group (P = 0.0001). No differences were found regarding satisfactory straightness (P = 0.13), satisfaction with the operation (P = 0.71), new use of erectile aids (P = 0.06), erectile pain (P = 0.12), or subjective penile shortening (P = 0.41). Patients who underwent plaque incision with grafting were more likely to experience loss of rigidity (P = 0.03), inability to have intercourse (P = 0.05), and loss of sensation (P = 0.0045). Patients who underwent plication were more likely to experience palpable nodules (P = 0.03). CONCLUSIONS: The results of our study have shown that both procedures are effective surgical options for the correction of Peyronie's disease. Plication is a simple procedure with less morbidity. Shortening is a common complaint, regardless of the type of operation done.

Sacral neuromodulation: cost considerations and clinical benefits.

OBJECTIVES: To demonstrate the efficacy of sacral neuromodulation and compare voiding-related health care utilization costs before and after receiving an implant. METHODS: A retrospective review of patients receiving InterStim therapy (Medtronic Neurological, Minneapolis, Minn) was completed. Health care utilization was determined for the year before and the year after implantation, and included hospital and clinic visits, diagnostic and therapeutic procedures, and prescriptions. Utilization costs were derived from Medicare CPT coding and reimbursement data. Drug costs were derived from the actual pharmacy costs. Efficacy was assessed subjectively by patient-reported questionnaire and objectively by voiding diary, pad usage, and number of catheterizations. RESULTS: Sixty-five patients received InterStim therapy. Outpatient visits for urinary symptoms decreased in the 12 months after implantation with a mean decrease of 2.2 visits (P <0.0001). This resulted in a 73% reduction in average yearly office visit expenses from $994 to $265 per patient. After implant, diagnostic and therapeutic procedures performed decreased by 0.97 (P <0.0001). This translated into a decrease in the cost of therapeutic and diagnostic procedures from $733 to $59 per patient (P <0.0001). Drug costs were significantly decreased (P <0.02) from $693 to $483 per patient. These cost savings represent a 92% reduction in outpatient doctor visits and diagnostic and procedure costs along with and a 30% reduction in drug expenditures. CONCLUSION: After InterStim therapy, voiding-related health care costs are reduced. InterStim therapy is an effective treatment option with high patient satisfaction for medically refractory voiding dysfunction.