You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology IV1 Apr 2017PD27-01 5 YEAR PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY RESULTS ON THE MINIMALLY INVASIVE PROSTATIC URETHRAL LIFT (PUL) Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Anthony Cantwell, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moselely, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoselelyWilliam Moselely More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1222AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) has been previously shown to rapidly and durably address lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal side effects. The 5 year concluding data from the largest multi-center, randomized, controlled, study on PUL is herein presented. METHODS PUL procedure involves placing permanent UroLift® implants into the lateral lobes of the prostate to enlarge the urethral lumen. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow rate = 12 ml/s, and prostate volume 30 - 80 cc. At 19 centers in North America and Australia, 206 men with symptomatic LUTS were randomized to PUL (N = 140) or sham control (N = 66). Patients and assessors were kept blinded to treatment arm for 3 months. Assessments for PUL subjects continued through 5 years. RESULTS PUL patients experienced symptom relief by 1 month (IPSS: 44% and QoL: 42%, p < 0.001) and remained improved through 5 years (IPSS: 38% and QoL: 54%, p < 0.001). Peak urinary flow rate remained improved 41% at 5 years. Sexual function was preserved in the PUL cohort, as assessments show stable erectile function average score and improved ejaculatory function and ejaculatory bother average scores (p<0.001). Further, no patient was found to experience de novo, sustained erectile or ejaculatory dysfunction. Adverse events were typically mild and transient. CONCLUSIONS The final long term data from the largest study on the PUL procedure demonstrates that this minimally invasive approach improves symptoms durably. Quality of life, BPH impact index and peak flow rate improvements are also sustained. As assessed by questionnaires and adverse event reporting, erectile and ejaculatory function are preserved. The final 5 year analysis indicates stable symptom relief and facilitates the understanding of the long term effects of the PUL procedure. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e511 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Anthony Cantwell More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moselely More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I1 Apr 2016PD21-02 PROSPECTIVE, RANDOMIZED, BLINDED STUDY OF PROSTATIC URETHRAL LIFT (PUL): FOUR YEAR RESULTS Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Anthony Cantwell, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moseley, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoseleyWilliam Moseley More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1469AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) procedure offers rapid, durable improvement in lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal adverse effects. PUL was assessed through a large, multi-center, randomized, blinded trial with 4 year follow up. METHODS 206 men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) were randomized to PUL (N=140) or sham control (N=66) at 19 centers in North America and Australia. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow (Qmax) = 12 ml/s, and prostate volume 30 - 80 cc. With endoscopic guidance, small, permanent metallic implants were transurethrally placed into the lateral lobes of the prostate. The lobes were held in a retracted, open position which reduced urinary obstruction. Through 3 month post index procedure, patients and assessors were kept blinded to treatment arm. PUL participants were assessed through 4 years via IPSS, quality of life (QOL), BPH Impact Index (BPH II), Qmax, Sexual Health Inventory for Men (SHIM), and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). RESULTS Average IPSS reduction was 44% by 1 month and 46% at 4 years (p value < 0.0001). Adverse events such as hematuria, dysuria, pelvic pain, urgency, and urge incontinence were typically mild and transient. There were no reported de novo, sustained erectile or ejaculatory adverse events. Sexual function assessments (SHIM, MSHQ-EjD) show stable erectile function average score and statistically improved average ejaculatory scores. For those subjects who have reached their 4 year follow up, 19 subjects have undergone repeat PUL or other procedure. CONCLUSIONS PUL patients suffer from little morbidity and on average achieve rapid, clinically meaningful LUTS relief. This preliminary data from the largest and longest study of the PUL procedure demonstrates that relief can be sustained to 4 years. In addition, sexual function is preserved, both in terms of erection and ejaculation. Durability will be assessed through protocol driven follow up through 5 years. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e456-e457 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Anthony Cantwell More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moseley More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2015PD5-01 THREE YEAR DURABILITY OF THE PROSTATIC URETHRAL LIFT FOR BPH: RESULTS OF A PROSPECTIVE, MULTI-CENTER, RANDOMIZED STUDY Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Thomas Brown, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moseley, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Thomas BrownThomas Brown More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoseleyWilliam Moseley More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.300AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To present an update of the pivotal, multi-center, randomized, blinded trial of the Prostatic Urethral Lift (PUL) through 3 years. METHODS Men were eligible for enrollment if they were ≥ 50 years and had symptomatic lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) with American Urological Association Symptom Index (AUASI) ≥ 13, peak flow (Qmax) ≤ 12 ml/s, and prostate volume 30 - 80 cc. During PUL, small permanent metallic implants were placed to hold lateral lobes in a retracted position and open the prostatic urethra. Randomized data (2:1) from PUL and sham were compared through 3 months, and then subjects in the PUL arm were followed for 3 years. RESULTS From February to December of 2011, 140 men were treated with PUL in the USA, Canada and Australia. AUASI reduction was 44% by 1 month and sustained at 43% through 3 years (p-value < 0.0001, refer to Table 1). Adverse events were typically mild and transient, with the most frequent being hematuria, dysuria, pelvic pain, urgency and urge incontinence. Sexual function was preserved with no incidence of de novo, sustained erectile or ejaculatory adverse events. Further, sexual function assessments show stable erectile function (Sexual Health Inventory for Men) score and statistically improved ejaculatory (Male Sexual Health Questionnaire for Ejaculatory Dysfunction) scores. There was a low incidence of LUTS retreatment, with only 12 subjects seeking PUL or other procedure over the course of 3 years. CONCLUSIONS The Prostatic Urethral Lift offers a clinically meaningful improvement in LUTS and urinary flow that can be sustained to 3 years. The procedure is associated with low morbidity and preservation of sexual function. This randomized study protocol provides the longest follow up of PUL to date and will continue to assess durability to 5 years. Table 1. Baseline, follow-up, and change in outcome measure for PUL subjects through 3 years. 2 Weeks 1 Month 3 Months 1 Year 2 Years 3 Years AUA SI N (paired) 135 135 136 123 104 62 Baseline 22.3 ± 5.5 22.3 ± 5.5 22.3 ± 5.5 22.1 ± 5.6 21.9 ± 5.6 21.4 ± 6.1 Follow-up 18.0 ± 7.9 12.3 ± 6.9 11.2 ± 7.7 11.5 ± 7.3 12.6 ± 7.8 12.0 ± 7.3 Change -4.3 -10.0 -11.1 -10.6 -9.2 -9.4 % Change -18% -44% -50% -47% -42% -43% 95% CI -12 to -23% -39 to -49% -44 to -55% -42 to -53% -35 to -48% -34 to -52% p-value < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 Quality of Life N (paired) 136 135 136 123 104 62 Baseline 4.6 ± 1.1 4.6 ± 1.1 4.6 ± 1.1 4.6 ± 1.0 4.5 ± 1.0 4.5 ± 1.0 Follow-up 3.6 ± 1.7 2.6 ± 1.7 2.4 ± 1.7 2.3 ± 1.6 2.3 ± 1.6 2.2 ± 1.5 Change -1.0 -2.0 -2.2 -2.3 -2.2 -2.3 % Change -18% -42% -47% -51% -48% -50% 95% CI -11 to -26% -36 to -49% -40 to -53% -44 to -57% -40 to -55% -40 to -59% p-value < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 BPH Impact Index N (paired) 136 135 136 123 104 62 Baseline 6.9 ± 2.8 6.9 ± 2.8 6.9 ± 2.8 6.8 ± 2.8 6.5 ± 2.9 6.4 ± 3.2 Follow-up 7.0 ± 3.5 4.0 ± 3.1 2.9 ± 3.0 2.8 ± 2.9 2.8 ± 2.9 2.5 ± 2.6 Change 0.1 -2.9 -4.0 -4.0 -3.8 -3.9 % Change 29% -33% -56% -57% -55% -50% 95% CI 8 to 50% -20 to -46% -48 to -64% -49 to -66% -45 to -65% -33 to -68% p-value 0.005 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 Peak flow (mL/s) N (paired) 122 102 87 39 Baseline 8.0 ± 2.4 8.0 ± 2.4 8.3 ± 2.4 8.3 ± 2.3 Follow-up 12.3 ± 5.3 12.1 ± 5.3 12.5 ± 5.4 11.3 ± 4.5 Change 4.3 4.0 4.2 3.0 % Change 64% 59% 59% 44% 95% CI 50 to 79% 43 to 74% 41 to 77% 24 to 65% p-value < 0.0001 < 0.0001 < 0.0001 < 0.0001 © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e92 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Thomas Brown More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moseley More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

AIMS:The goal of this study was to evaluate whether the intravaginal electrode used to perform vaginal electrical stimulation could induce acute changes on the cystometrograms and urethral pressure profiles (UPP) recordings. METHODS:Three consecutive urodynamic examinations were performed on 30 women with stress urinary incontinence (SUI) symptoms. The first exam was performed without the electrode, the second with the electrode inserted into the vagina, but with the stimulator switched off and the third with the stimulator turned on. We used the INNOVA (Empi) stimulator with electrical parameters set at 50 Hz and 60 mA and on an intermittent cycle during the cystometries and a continuous stimulation during the UPP. The data of functional profile length (FPL), maximum urethral closure pressure (MUCP), and area of the resting UPP, as well as the filling sensations and its respective bladder volumes during the cystometries, were compared. With regard to the cystometries. RESULTS:No effect of the electrode was observed on cystometry. However, the simple presence of the electrode improved the FPL, MUCP, and areas of the UPP similar to those when the stimulation was applied. CONCLUSIONS:We conclude that, the presence of the intravaginal electrode induces changes in the UPP not related to the stimulation itself. The physiotherapeutic effect of the electrode itself is still to be evaluated.

PURPOSE:Neurogenic impotence is a common complication after radical pelvic surgery, irradiation or perineal trauma. Neuronal transplantation is a new frontier for treating neurological disorders. We investigated whether the major pelvic ganglion can survive and become functional after being implanted into the corpus cavernosum in adult rats. MATERIALS AND METHODS:Adult male rats (13) were divided into 3 groups and sacrificed at 3 time points, namely 30 (4), 60 (5) and 90 (4) days. All rats underwent excision of the right major pelvic ganglion and left cavernous nerve. The right ganglion was implanted into the right crus of the penis. Electrostimulation was applied to the left major pelvic ganglion and cavernous nerve (1.5 mA.) and right crus (10 mA.) at sacrifice. The crural region and left ganglion were then excised for immunostaining of neuronal nitric oxide synthase (nNOS), protein gene product 9.5 and growth associated protein 43. Image analysis was used to calculate the area stained in pixels. Electron microscopy of the implanted area was performed to assess neuronal survival. RESULTS:Although the degree varied, all neuronal implants survived after transplantation. The response to electrostimulation was insufficient to produce erection. No difference was noted among the areas of nNOS staining when specimens from the 3 time points were compared. The area of expression of nNOS, protein gene product 9.5 and growth associated protein 43 was larger in the implanted area than in the surrounding cavernous tissue. Under electron microscopy most surviving implants showed normal ultrastructure, although areas of fibrotic replacement were seen in several implants. CONCLUSIONS:Our results show that the autotransplanted major pelvic ganglion expresses nNOS, protein gene product 9.5 and growth associated protein 43, and survived up to 90 days after implantation into the corpus cavernosum. Further studies with fetal neuronal tissue seem warranted.

Purpose: Flank incisions may be associated with flank hernias, which may be complicated by incarceration and strangulation. Furthermore, they may be the cause of significant patient dissatisfaction with the surgical outcome. To avoid an open surgical procedure with its associated morbidity for hernia repair we describe a novel laparoscopic technique for repairing flank hernias with minimal morbidity and an excellent outcome.Materials and Methods: Three cases of flank hernia were managed by the transperitoneal preperitoneal laparoscopic approach using polypropylene mesh to repair the fascial defect. An initial transperitoneal approach helps to identify the limits of the hernia. A 2 to 3 cm. margin of overlying peritoneum is incised around the hernia margin. It is important not to dissect overlying bowel. The mesh is placed behind the peritoneal envelope and secured with hernia staples.Results: All cases were managed successfully via laparoscopy. There were no intraoperative or postoperative complications. At a mean followup of 12 months cosmesis has been excellent and there have been no recurrences.Conclusions: We describe a minimally invasive, versatile technique for laparoscopic repair of flank incisional hernias with excellent functional and cosmetic results. This approach avoids the significant morbidity associated with open repair of incisional flank hernias.

Penile arterial insufficiency is one of the most common causes of ED. We have established a traumatic arteriogenic insufficiency rat model by the ligation of the pudendal arteries. To simulate both acute and chronic traumatic injuries, five ligation periods (6 h, 3 days, 7 days, 3 weeks, and 6 weeks) were chosen. By electrostimulation of the cavernous nerve, the intracavernous pressure was determined to be between 20 and 40-cm H(2)O for the ligated rats compared to around 100-cm H(2)O for the control rats. The erectile tissue in the corpus cavernosum of these rats was then subjected to microarray analysis, in which an array that contains cDNA fragments representing 1176 rat genes was used. The results demonstrated that normal rat corpus cavernosum expressed approximately 200 genes at detectable levels and that ligation produced differential expression of approximately 25 genes, depending on the duration of ligation. The most highly ligation-induced gene was apolipoprotein D (ApoD), with peak expression in the 3- and 7-day ligated rats. Three of the insulin-like growth factor binding proteins (IGFBP-1, 3, and 5) were upregulated in all ligated rats. IGFBP-6, which was one of the most highly expressed genes in the normal corpus cavernosum, was down-regulated in all ligated rats. Cysteine proteases of the cathepsin family were also differentially expressed between control and ligated rats, with cathepsin K being down-regulated most. A few genes were upregulated only in the 6-week ligated rats, including angiotensin-converting enzyme. Finally, VEGF, whose induction has been identified in many other ischemic tissues, was not induced in corpus cavernous tissue of ligated rats.

PURPOSE:Digoxin use has long been recognized to affect adversely male sexual function but the underlying mechanism is poorly understood. Digoxin is a known inhibitor of sodium/potassium adenosine triphosphatase (sodium pump), a plasma membrane enzyme that has a role in the regulation of smooth muscle tone. We investigated the effects of digoxin on human corpus cavernosum smooth muscle contractility and overall erectile function.MATERIALS AND METHODS:In human corporeal smooth muscle strips the in vitro effects of digoxin were assessed on sodium pump activity as measured by digoxin inhibitable uptake of 86rubidium, basal tone and endothelium dependent, neurogenic and nitric oxide donor induced relaxation. An in vivo prospective double-blind, placebo controlled, crossover, 4-period investigation was performed in 6 healthy male volunteers. The effects of digoxin on serum hormones, erectile function questionnaire, visual sexual stimulation and nocturnal penile tumescence were recorded.RESULTS:In vitro digoxin caused concentration dependent inhibition of 86rubidium uptake (half maximum effect at 0.01 microM.) and contraction of corporeal smooth muscle (half maximum effect at 0.8 microM.). Therapeutic concentrations of digoxin (2 nM.) also inhibited relaxation induced by acetylcholine and electrical field stimulation, which release nitric oxide from corpus cavernosum endothelial cells and nonadrenergic noncholinergic nerves, respectively. In vivo digoxin diminished penile rigidity during visual sexual stimulation and nocturnal penile tumescence testing compared to placebo without influencing libido or serum testosterone, estrogen or luteinizing hormone levels.CONCLUSIONS:Digoxin associated alteration of human erectile function may be explained, in part, by inhibition of corporeal smooth muscle sodium pump activity, which promotes contraction and impedes nitric oxide induced relaxation. Such findings suggest therapeutic use of digoxin for treatment of recurrent priapism states.