The Virtue quadratic male sling for postradical prostatectomy urinary incontinence: 3-Year outcome measurements and a predictive model of surgical outcome from a European prospective observational study.

AIMS: This prospective multicenter observational study evaluated postprostatectomy incontinence treatment outcomes with Virtue male sling at 12 and 36 months. METHODS: Objective assessment was based on a 24-h pad weight test with improvement defined by a decrease >50% and cure by less than 1.3 g. Subjective assessment was based on the patient global impression of improvement and International Consultation on Incontinence Questionnaire-urinary incontinence-short form (ICIQ-UI-SF) questionnaires. Subgroups were analyzed by baseline severity of incontinence on a 24-h-pad test, body mass index (BMI), and pads usage. Factors associated with treatment response were assessed using logistic regression at Months 36. Complications were reported. RESULTS: We analyzed data from 117 men. Objective and subjective improvement were achieved in 54% and 35% and 51% and 34% at 12 and 36 months, respectively. Twenty-one percent and 19% were considered cured, respectively, at 12 and 36 months. No differences per baseline incontinence severity, BMI and pads usage were found at 36 months. Mean ICIQ-UI-SF score decreased from 15 to 9. Predictive factors were BMI, postvoid residual urine, number of nighttime urination, and ICIQ total score. Seven Clavien-Dindo Grade III (5.1%) including four Virtue sling revisions were reported. The most frequent Grade II complications were overactive bladder symptoms and pain reported in 10.3% and 2.9%, respectively. No complications required explantation. CONCLUSIONS: Virtue male sling is safe and effective in males with mild to severe postprostatectomy urinary incontinence over 36 months. Virtue could be considered an interesting option for postradical prostatectomy urinary incontinence with positive results over time even in patients with high BMI. The predictive model should be validated by further studies.

Comparison of the iliac, vaginal and umbilical graft extraction in robot-assisted laparoscopic living donor nephrectomy.

PURPOSE: To compare different extractions routes for robot-assisted living donor nephrectomy in terms of post-operative pain and renal function recovery. METHODS: Live donor kidney transplantation data from our institution were reviewed from November 2011 to March 2017. Postoperative pain was estimated using cumulative painkillers consumption. Variables were compared between the 3 groups with ANOVA for continuous data, χ2 test for categorial data. A survival analysis with Kaplan-Meier curve assessing time to transplant recipient nadir was performed to compare the renal function recovery. RESULTS: Sixty-three RLDN were performed (23 iliac, 23 vaginal and 17 umbilical extractions). There was no significant difference between the three groups in terms of operative time, blood lost, warm ischemia time, cumulative painkiller consumption and renal function recovery time. Postoperative complications for Umbilical, Vaginal and Iliac were, respectively, of 0, 3 and 1. No major difference was found between the 3 groups beside a slightly longer hospital stay in the iliac group. CONCLUSION: Iliac incision might impact post-operative pain with a moderate but significant longer hospital stay. Vaginal extraction is an option when cosmetic outcomes present a real demand. The three options appeared to be safe and should be discussed with the patient in regard of the surgeon experience.

Extraperitoneal Robot-Assisted Vesicourethral Reconstruction to Manage Anastomotic Stricture Following Radical Prostatectomy.

OBJECTIVE: To demonstrate the feasibility of robot-assisted vesicourethral reconstruction. Vesicourethral anastomotic stricture following radical prostatectomy is a real challenge for reconstructive surgery when facing several endoscopic management failures. MATERIAL AND METHODS: This is a case series of robot-assisted vesicourethral reconstruction for anastomotic stricture failing endoscopic management. The procedure was performed with an extraperitoneal approach. The fibrotic anastomotic region was resected and a new vesicourethral running suture was performed with well-vascularized tissue. Bladder catheter was removed after 7 days. RESULTS: Six procedures were performed from April 2013 to May 2018 at our department. One patient had a robot-assisted radical prostatectomy at our department; the 5 others were referred from other institutions after receiving open prostatectomies. Three patients had salvage radiation therapy before reconstruction. Mean age was of 73.8 years (68-82). There was no peroperative complication. Mean operative time was of 108 minutes (60-180)], with a mean estimated blood loss of 130 mL (50-300). After surgery, 3 patients presented recurrences managed endoscopically without recurrence after 3, 5, and 11 months. Three patients presented incontinence treated with artificial sphincter implantation. One patient had no residual symptom after 5 years of follow-up. CONCLUSIONS: Robot-assisted vesicourethral reconstruction is a safe procedure. It is an option to consider when facing recurring anastomotic stricture following radical prostatectomy. It is an alternative to the perineal approach and an option before urinary diversion. Patients should be informed of the risks of incontinence and recurrence before surgery especially if they had radiation therapy.

Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction: Final Results of the INSTIN Clinical Trial.

We recently reported stage I of a phase 1/2 clinical trial of cell therapy to treat postradical prostatectomy erectile dysfunction (INSTIN, INtra-cavernous STem-cell INjection clinical trial, NCT01089387). In this first stage, four doses of intracavernous autologous bone marrow mononuclear cells (BM-MNCs) were tested in 12 patients. Here, we report the results of stage II, in which six additional patients received the optimal dose identified in stage I (109 BM-MNCs), and the long-term results in the 12 patients included in stage I. The objectives were to assess the safety and efficacy of this new treatment. In stage II, no patients had side effects, and the erectile function improvements were similar to those seen in stage I: after 6 months, significant improvements versus baseline were noted in International Index of Erectile Function-15 intercourse satisfaction (7.8±3.1 vs 2.2±3.4, p=0.033) and erectile function (18±8.3 vs 3.7±4.1, p=0.035) domains. In stage I patients, after a mean follow-up of 62.1±11.7 mo, there were no prostate cancer recurrences, and erectile function scores were somewhat lower compared with the 1-yr time point. These findings suggest that intracavernous BM-MNC injections are safe and improve erectile function. The decline in erectile function over time suggests a need for assessing repeated injections. PATIENT SUMMARY: We report a phase 1/2 pilot clinical trial of cell therapy consisting in intracavernous injection of bone marrow mononuclear cells to treat postradical prostatectomy erectile dysfunction. Erectile function was improved after 6 mo in the patients given 1×109 cells. No serious side effects (life threatening or requiring hospitalisation) occurred after a mean follow-up of 62.1 mo in the first 12 patients.

Update on 2-year outcomes of the TOMS™ transobturator male sling for the treatment of male stress urinary incontinence.

AIMS: To update the 2-year outcomes of the TOMS™ transobturator male sling for treating post-prostatectomy urinary incontinence (pRP-UI) in a group of patients previously evaluated at 1 year. METHODS: We prospectively followed 40 patients with pRP-UI before and 6, 12, and 24 months after implantation of the TOMS™ transobturator male sling. Urinary symptoms were evaluated using the following questionnaires: USP, ICIQ, UCLA-PCI (urinary bother domain), PGI-I, and daily pad use. Success was defined as patients wearing no or only one security pad. We also report on any other surgical procedures for treating persistent incontinence during the follow-up period. RESULTS: Of 40 patients included in the 1-year follow-up, seven required additional surgical treatment. In the remaining patients (n = 33), significant improvement (P < 0.001) compared to baseline was seen, and a subsequent tendency (non-significant) toward impairment was noted throughout the three postoperative follow-ups for the ICIQ (14.4 ± 4.4 [baseline], 7.6 ± 5.7 [6 months], 8.1 ± 5.6 [12 months], 8.9 ± 5.5 [24 months]), USP-stress urinary (6.7 ± 2.2, 2.8 ± 2.4, 2.8 ± 2.4, 3.2 ± 2.8), ULCA-PCI-urinary bother (10.0 ± 12.5, 66.0 ± 33.0, 64.0 ± 31.5, 62.0 ± 30.7) scores, and pad use (2.5 ± 1.2, 0.7 ± 1.1, 0.8 ± 1.2, 0.9 ± 1.2). Significant impairment in postoperative PGI-I (6.2 ± 0.9, 6.1 ± 0.9, 5.8 ± 1.1, P = 0.028) and USP-overactive bladder symptoms scores (5.4 ± 3.6 [6 months] vs. 6.6 ± 3.7 [24 months], P = 0.046) were noted. A total of 18 (54.5%), 17 (51.5%), and 15 (45.5%) patients wore no postoperative pad, respectively. CONCLUSION: Approximately half of the patients continue to wear no pad 2 years after TOMS™ transobturator male sling implantation. However, a tendency toward impaired continence, possibly associated with overactive bladder symptoms, was noted.

Delivery of human mesenchymal adipose-derived stem cells restores multiple urological dysfunctions in a rat model mimicking radical prostatectomy damages through tissue-specific paracrine mechanisms.

Urinary incontinence (UI) and erectile dysfunction (ED) are the most common functional urological disorders and the main sequels of radical prostatectomy (RP) for prostate cancer. Mesenchymal stem cell (MSC) therapy holds promise for repairing tissue damage due to RP. Because animal studies accurately replicating post-RP clinical UI and ED are lacking, little is known about the mechanisms underlying the urological benefits of MSC in this setting. To determine whether and by which mechanisms MSC can repair damages to both striated urethral sphincter (SUS) and penis in the same animal, we delivered human multipotent adipose stem cells, used as MSC model, in an immunocompetent rat model replicating post-RP UI and ED. In this model, we demonstrated by using noninvasive methods in the same animal from day 7 to day 90 post-RP injury that MSC administration into both the SUS and the penis significantly improved urinary continence and erectile function. The regenerative effects of MSC therapy were not due to transdifferentiation and robust engraftment at injection sites. Rather, our results suggest that MSC benefits in both target organs may involve a paracrine process with not only soluble factor release by the MSC but also activation of the recipient's secretome. These two effects of MSC varied across target tissues and damaged-cell types. In conclusion, our work provides new insights into the regenerative properties of MSC and supports the ability of MSC from a single source to repair multiple types of damage, such as those seen after RP, in the same individual.

Safety of Intracavernous Bone Marrow-Mononuclear Cells for Postradical Prostatectomy Erectile Dysfunction: An Open Dose-Escalation Pilot Study.

UNLABELLED: Evidence from animal models replicating postradical prostatectomy erectile dysfunction (pRP-ED) suggests intracavernous injection of bone marrow-mononuclear cells (BM-MNCs) as a promising treatment approach for pRP-ED. We conducted a phase 1/2 pilot clinical trial of intracavernous autologous BM-MNC injection to treat pRP-ED (NCT01089387). Twelve patients with localized prostate cancer and vasculogenic pRP-ED refractory to maximal medical treatment were divided into four equal groups treated with escalating BM-MNC doses (2×10(7), 2×10(8), 1×10(9), 2×10(9)). Tolerance was the primary endpoint. Secondary endpoints were the effects on erectile function and penile vascularization at 6 mo, as assessed using the International Index of Erectile Function-15 and Erection Hardness Scale questionnaires, and color duplex Doppler ultrasound. We measured the peak systolic velocity in cavernous arteries and assessed endothelial function using the penile nitric oxide release test. No serious side effects occurred. At 6 mo versus baseline, significant improvements of intercourse satisfaction (6.8±3.6, 3.9±2.5, p=0.044) and erectile function (17.4±8.9, 7.3±4.5, p=0.006) domains of the International Index of Erectile Function-15 and Erection Hardness Scale (2.6±1.1, 1.3±0.8, p=0.008) were observed in the total population. Spontaneous erections showed significantly greater improvement with the higher doses. Clinical benefits were associated with improvement of peak systolic velocity and of % penile nitric oxide release test and sustained after 1 yr. Our results need to be confirmed by phase 2 clinical trials. PATIENT SUMMARY: We report a phase 1/2 pilot clinical trial investigating cell therapy with injection of bone marrow mononucleated cells to treat postradical prostatectomy erectile dysfunction. No serious side effects occurred. Improvements of erectile function and penile vascularization were noted. Further studies are required to confirm these preliminary results.

Combined Implantation of a Penile Prosthesis and Adjustable Continence Therapy ProACT in Patients with Erectile Dysfunction and Urinary Incontinence after Radical Prostatectomy: Results of a Prospective Pilot Study.

INTRODUCTION: The treatment of postradical prostatectomy erectile dysfunction (post-RP-ED) and stress urinary incontinence (post-RP-SUI) may require the combined implantation of a penile prosthesis and incontinence surgery. However, there is a lack of consensus regarding which incontinence surgery should be associated with a penile implant. AIMS: To evaluate the combined implantation of a penile prosthesis and the adjustable continence therapy ProACT in patients with post-RP-ED and post-RP-SUI. METHODS: We implanted the ProACT device and a penile prosthesis synchronously (n = 6) and asynchronously (n = 4) in 10 patients with moderate post-RP-SUI and severe post-RP-ED. We evaluated the effects on urinary incontinence using the ICIQ and PGI-I scores and pad use. We evaluated the effect on sexual function using the EHS and Global Assessment Questionnaire (GAQ), and we evaluated satisfaction with the penile prosthesis on a 5-point scale. Postoperative pain associated with each procedure was evaluated by a numeric rating scale. RESULTS: No cases of urinary retention or prosthesis infection were observed. Postoperative pain was mainly related to penile prosthesis implantation. After a mean follow-up of 22.7 ± 20.9 months (range: 6-53), significant improvements of the ICIQ score (15.3 ± 3.7 vs. 4.7 ± 2.3, P < 0.001) and pad use per day (2.8 ± 1.2 vs. 0.3 ± 0.5, P < 0.001) were observed compared with baseline. According to the PGI-I questionnaire, eight patients described a very much improved (n = 6) or much improved (n = 2) urinary condition. All patients declared an EHS = 4 with the use of penile prosthesis; all patients were very satisfied (n = 6) or satisfied (n = 4) with their penile prosthesis. All patients answered the GAQ positively. CONCLUSION: The combined implantation of a Pro-ACT device and penile prosthesis represents a feasible therapeutic option in patients with post-RP-SUI and post-RP-ED. The absence of postoperative pain associated with the ProACT procedure may represent the main interest in this therapy.

Is it worth continuing sexual rehabilitation after radical prostatectomy with intracavernous injection of alprostadil for more than 1 year?

INTRODUCTION: Intracavernous alprostadil injection (IAI) is a widely used treatment for sexual rehabilitation (SR) after radical prostatectomy (RP). It is unknown whether the continuation of IAI beyond 1 year continues to improve erectile function. AIMS: To assess evolution of sexual function in patients using IAI who are nonresponsive to phosphodiesterase type 5 inhibitors (PDE5i) between 12 (M12) and 24 (M24) months after RP. METHODS: We retrospectively studied 75 men with a nerve-sparing laparoscopic RP, who had normal preoperative erectile function, and who regularly used IAI for SR for at least 24 months. At M12, no patients had responded to PDE5i. MAIN OUTCOME MEASURES: At 12 and 24 months, sexual function was assessed with the UCLA Prostate Cancer Index (UCLA-PCI), International Index of Erectile Function (IIEF)-15, and erection hardness score (EHS) with and without IAI. We also assessed the satisfaction rate with IAI, injection-related penile pain, and satisfaction of treatment. Statistical analysis was performed by using t-tests for paired data and Spearman's rho correlation coefficients to assess the relationships between scores at M12 and M24. RESULTS: Improvement of nocturnal erection was noted (UCLA-PCI, question 25); however, no significant difference was found for IIEF-erectile function with (19.60 ± 9.80 vs. 18.07 ± 10.44) and without IAI (4.63 ± 2.93 vs. 4.92 ± 4.15), UCLA-PCI-sexual bother (37.14 ± 21.45 vs. 37.54 ± 19.67), nor the EHS score with (2.97 ± 1.30 vs. 2.57 ± 1.30) and without IAI (0.67 ± 1.11 vs. 0.76 ± 0.10). The rate of satisfaction with treatment decreased over time (66.6% vs. 46.7%, P = 0.013). Improved response to IAI at M12 was not correlated to improvement in spontaneous erections at M24. CONCLUSION: The response to IAI remained stable after 2 years of treatment, and no significant improvement of spontaneous erections during intercourse attempts was found between M12 and M24. Patients should be informed of the limited effect of IAI on natural erections after 1 year. Yiou R, Bütow Z, Parisot J, Binhas M, Lingombet O, Augustin D, de la Taille A, and Audureau E. Is it worth continuing sexual rehabilitation after radical prostatectomy with intracavernous injection of alprostadil for more than 1 year? Sex Med 2015;3:42-48.

International Prostate Symptom Score is a predictive factor of lower urinary tract symptoms after radical prostatectomy.

OBJECTIVE: To evaluate the impact of radical prostatectomy on lower urinary tract symptoms by using the International Prostate Symptom Score and International Prostate Symptom Score quality of life. METHODS: The present prospective study comprised 804 patients having localized prostate cancer who underwent radical prostatectomy. International Prostate Symptom Score and International Prostate Symptom Score quality of life were recorded preoperatively, and at 1, 3, 6, 12 and 24 months. Two study groups were considered: group 1 included patients with International Prostate Symptom Score ≤7 (mild) and group 2 included patients with International Prostate Symptom Score ≥8 (moderate to severe). Student's t-test and logistic regression were carried out to detect a predictive factor of International Prostate Symptom Score ≤7 at 24 months. RESULTS: The mean International Prostate Symptom Score was 5.58 ± 6.6, 11.12 ± 7.1 and 7.62 ± 6 at baseline, 1 month and 3 months, respectively (P <0.0001). The mean quality of life score showed the same evolution with a significant difference at 1 and 3 months. The mean International Prostate Symptom Score was initially 1.57 ± 1.9 in group 1 and 13.51 ± 5.5 in group 2 (P <0.0001), evolving to 3.41 ± 3.1 and 7.69 ± 5.8 at 24 months (P <0.0001), respectively. The mean quality of life score was significantly different between the groups initially, and at 6 and 12 months with P <0.0001, P = 0.005 and P = 0.02, respectively. The multivariate logistic regression showed that age, prostate volume and preoperative International Prostate Symptom Score were independent predictive factors of International Prostate Symptom Score ≤7 at 24 months (P <0.0001). In group 2, 47 patients (17%) had an International Prostate Symptom Score ≥8 at 24 months, 15 of them (32%) having a QoL score ≥3. CONCLUSIONS: The present study shows the beneficial impact of radical prostatectomy on lower urinary tract symptoms. However, a proportion of patients with a baseline International Prostate Symptom Score ≥8 maintain the same score at 24 months, with worsening in quality of life score in one-third of them.

Adjustable continence therapy (ProACT™) after male sling failure for patients with post-radical prostatectomy urinary incontinence: a prospective study with one-year follow-up.

PURPOSE: To assess the effects of the ProACT™ device as a second-line treatment for persistent incontinence after male sling insertion. METHODS: Twenty consecutive patients were treated with the ProACT™ device due to persistent urinary incontinence following male sling insertion (9 AdVance™, 9 TOMS™, 2 InVance™). All balloons were implanted using a combination of fluoroscopic imaging and fibroscopic retrovision. Urinary symptoms were assessed prior to male sling insertion (T0) and before (T1) and 1 year after the ProACT™ insertion (T2) using questionnaires (ICIQ, USP, and ULCA-PCI-urinary bother) and by determining the number of pads used daily. RESULTS: The mean age of the study population at T1 was 68.6 ± 9 years. The mean volume of adjustment at T2 was 4.5 ± 2.7 mL. The previous sling did not cause any technical difficulties during ProACT™ insertion. Late wound infections occurred in the two patients who had been previously treated with the InVance sling and required removal of all implanted materials (Clavien-Dindo classification IIIb). Improvement in mean urinary scores was noted in the remaining patients (n = 18) through T0, T1, and T2, respectively: The ICIQ scores were 16.8 ± 2.6, 13.1 ± 3.4, and 5.7 ± 5.7 (P < 0.0001); USP stress urinary incontinence scores were 8 ± 1.8, 5.6 ± 2.2, and 2.4 ± 2.8, (P < 0.0001); USP overactive bladder symptom scores were 6.8 ± 4.3, 7.6 ± 4.3, and 4.1 ± 3.5 (P = 0.008), UCLA-PCI urinary bother scores were 7.1 ± 11.3, 28.6 ± 12.9, and 69.6 ± 31.6 (P < 0.0001), and number of pads used were 2.9 ± 1, 2 ± 1, and 0.3 ± 0.9 (P < 0.0001). USP obstructive symptoms were 0.4 ± 1, 1 ± 1.6, and 1.3 ± 1.4 (P = 0.19). CONCLUSIONS: The Pro-ACT™ device may provide additional benefits for improving continence in case of persistent incontinence following male sling insertion.

Comprehensive evaluation of embarrassment and pain associated with invasive urodynamics.

AIMS: To evaluate pain and embarrassment associated with invasive urodynamics and to determine underlying factors. METHODS: One hundred seventy one consecutive patients referred to our department for invasive urodynamics were evaluated using visual numeric rating scales for sensations of apprehension, pain, and embarrassment during several steps of the procedure (scores ranging from 0 [no symptom] to 10 [worst imaginable symptom]). We also investigated the influence of sex, age, information provided before urodynamics, and medical indication on these sensations. The Spearman correlation, non-parametric test, and logistic regression analysis were performed to determine explicative factors for the most painful sensations. RESULTS: The mean age was 61.0 (standard deviation ± 15 years). The mean (95% confidence interval [CI]) apprehension level was 2.9/10 (2.4; 3.4). The mean (95% CI) pain levels at installation on urodynamic table, transurethral catheter insertion (cystometry), and catheter repositioning (urethral pressure profilometry) were 0.3/10 (0.1; 0.5), 1.9/10 (1.6; 2.3), and 1.3/10 (1.0; 1.7), respectively. At catheter insertion, 25% of patients reported a pain level ≥ 4/10. The mean embarrassment level due to urination in front of the doctor was 1.9/10 (1.4; 2.3). Painful sensations reported during the different steps were strongly correlated with each other and with levels of apprehension and embarrassment. Age <54 years (lower quartile) and apprehension level were the only factors associated with painful sensation. CONCLUSIONS: Our study confirms that invasive urodynamics is a well-tolerated procedure. However, some patients experience high levels of pain and embarrassment throughout the procedure. Younger age and apprehension were the most influential factors.

Evaluation of urinary symptoms in patients with post-prostatectomy urinary incontinence treated with the male sling TOMS.

AIMS: To evaluate stress urinary incontinence (SUI), overactive bladder (OAB), and obstructive symptoms in patients with post-radical prostatectomy urinary incontinence (pRP-UI) treated with the bulbar compressive sling TOMS, and investigate the effect of each urinary symptom on urinary bother. MATERIALS AND METHODS: We prospectively followed 40 patients with pRP-UI before, and 6 and 12 months (T6 and T12, respectively) after implantation of the TOMS sling. Urinary symptoms were evaluated using the following questionnaires: USP, ICIQ, UCLA-PCI (urinary bother domain), PGI-I, and daily pad use. Success was defined as patients wearing no pads or using one security pad. RESULTS: Significant improvement of mean USP-SUI (6.97/9, 3.35, 3.02, P < 0.001) and USP-OAB domains (8.1/21, 5.74, 5.71, P < 0.001), ICIQ (15.15/21, 8.17/21, 8.35/21, P < 0.01), urinary bother (92.5/100, 42.5, 41.87, P < 0.001), and pad number (2.78, 1.01, 1.03, P < 0.001) were noted between baseline, T6, and T12. At baseline, 32 (80%) patients reported urge incontinence. Urinary bother strongly correlated with UPS-SUI but not with UPS-OAB score. At T12, 22 (55%) patients with pad use were considered cured, and 13 (32.5%) patients reported a greatly improved urinary tract condition (PGI-I). Improvement of USP-SUI and USP-OAB scores correlated with improvement of ICIQ and PGI scores. The USP-obstructive domain remained unchanged. CONCLUSION: The TOMS sling improves SUI and OAB symptoms without generating obstructive symptoms. OAB symptoms including urge incontinence reported by most patients were not a major concern at baseline; however, improvement of these symptoms was associated with improvement of continence and PGI-I scores.

Erection hardness score for the evaluation of erectile dysfunction: further psychometric assessment in patients treated by intracavernous prostaglandins injections after radical prostatectomy.

INTRODUCTION: Erectile dysfunction (ED) affects quality of life in patients treated by radical prostatectomy (RP). The Erection Hardness Score (EHS) is a single-item scale that has demonstrated good psychometric properties for assessing erectile function (EF) in patients treated by sildenafil, but its applicability to other treatment contexts has not yet been tested. AIM: This study aims to test the validity and time and treatment responsiveness of the EHS to assess ED in men with post-RP ED treated with alprostadil injections. METHODS: This is a 1-year follow-up cohort study of 75 patients treated by RP for localized prostate cancer in a urology department setting between January 2007 and December 2008. Data were prospectively collected at 6 and 12 months post-RP. MAIN OUTCOME MEASURES: The EHS, the International Index of Erectile Function (IIEF) reference questionnaire, the Global Assessment Questionnaire (GAQ), and Numeric Pain Scale (NPS) were collected. Convergent validity (Spearman correlation coefficients with IIEF domains), known-groups validity (comparing EHS scores across ED severity groups), time and treatment responsiveness (effect size with/without treatment and over the follow-up period), and predictive ability (area under the receiver operating characteristics curve [AUC-ROC]) were analyzed for this study. RESULTS: The EHS showed good convergent validity (all Spearman coefficients significant at the P<0.05 level), adequate known-groups validity (global differentiation between IIEF-EF severity groups; P<0.001), and treatment responsiveness (effect size: +1.8 [6 months], +2.1 [12 months]), but limited time responsiveness and predictive ability of the EHS for a normal EF at 12 months follow-up when compared with the IIEF-EF domain (AUC-ROC: 0.72 vs. 0.85; P<0.01). CONCLUSION: Our findings support the overall good psychometric properties of the EHS in patients with post-RP ED treated with alprostadil injections. However, evidence for limited predictive validity and responsiveness to change over time should be considered for its use in clinical follow-up in this population.

[Functional anatomy of the pelvic floor]. / Anatomie fonctionnelle du plancher pelvien.

The pelvic floor is the support of the pelvic viscera. The levator ani muscle (LA) with its two bundles (pubo- and iliococcygeus) is the major component of this pelvic floor. LA is formed essentially by type I fibers (slow twitch, with high oxidative capability and presence of slow myosin) as in postural muscles. The aerobic metabolism makes LA fragile to excentric contraction and to mitochondrial dysfunction. The innervation of the pelvic floor comes from the 2nd, 3rd, 4th anterior sacral roots; denervation affects pelvic dynamism. Perineum includes the musculofascial structures under the LA: ventrally the striated sphincter of urethra and the ischiocavernosus and bulbospongiosus, caudally the fatty tissue filling the ischioanal fossa. Pelvic fascia covers the muscles ; it presents reinforcements : the uterosacral and cardinal ligaments, the arcus tendineus fascia pelvis (ATFP) and the arcus tendineus levator ani (ATLA). The pelvis statics is supported by the combined action of all this anatomical structures anteriorly forming the perineal "hammock," medially the uterosacral and cardinal ligaments, posteriorly the rectovaginal fascia and the perineal body. The angles formed by the pelvic viscera with their evacuation ducts participate to the pelvic statics. During the pelvic dynamics the modification of these angles expresses the action of the musculofascial structures.

Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Cell therapy using muscle precursor cell (MPC) injections has shown promise for urinary incontinence due to intrinsic sphincter deficiency (ISD), but the cell-preparation process is complex and costly. Implantation of freshly isolated myofibres carrying MPCs, mainly satellite cells, was very efficient in repairing muscle damage in recent animal experiments. In a phase I clinical trial, we investigated whether periurethral myofibre implantation generated local myogenesis and improved continence in 10 patients (five men and five women) with ISD. We found that myofibre implantation increased intraurethral pressure and periurethral electromyographic activity in patients with ISD. There were no serious side-effects. OBJECTIVES: To assess the safety of periurethral myofibre implantation in patients with urinary incontinence due to intrinsic sphincter deficiency (ISD) To assess the resulting myogenic process and effects on urinary continence. PATIENTS AND METHODS: An open-label non-randomised phase I clinical trial was conducted in five men and five women with ISD (mean age, 62.5 years). A free muscle strip from the patient's gracilis muscle was implanted around the urethra as a means to deliver locally myofibres and muscle precursor cells (MPCs). Patients were assessed for collection formation and incomplete bladder emptying. The maximum urethral closure pressure (MUCP) and concomitant periurethral electromyographic (EMG) activity were recorded before surgery and 1 and 3 months after surgery. Continence was assessed using the 24-h pad test and self-completed questionnaires, for 12 months. RESULTS: There were no serious side-effects. Continence improved significantly during the 12-month follow-up in four of the five women, including two who recovered normal continence. In the women, MUCP increased two-fold and de novo EMG periurethral activity was recorded. In the men, MUCP and EMG recordings showed similar improvements but the effect on continence was moderate. The few patients enrolled could affect these results. CONCLUSIONS: This is the first report of a one-step procedure for transferring autologous MPCs via myofibre implantation in patients with ISD. EMG and urodynamic assessments showed improvement of periurethral muscle activity. Further work is needed to confirm and improve the therapeutic efficiency of this procedure.

Sexual quality of life in women partnered with men using intracavernous alprostadil injections after radical prostatectomy.

INTRODUCTION: The effects of intracavernous alprostadil injection (IAI), a primary treatment for post-radical prostatectomy (RP) erectile dysfunction (ED) (pRPED), on the sex life of women partnered with men who have undergone RP have received little attention. AIMS: The aim of this study is to investigate the sexual quality of life in female partners of men receiving IAIs for pRPED. METHODS: We retrospectively studied the sex lives of 152 women partnered with men who were being treated for pRPED with IAI and previously had normal erectile function. Women completed the Index of Sexual Life (ISL) questionnaire 1 year after their partner's RP. Male patients completed the International Index of Erectile Function (IIEF-15), the Erection Hardness Score (EHS) questionnaire, the International Consultation on Incontinence Questionnaire (ICIQ), and the UCLA Prostate Cancer Index (UCLA-PCI) urinary function questionnaire. Penile pain was assessed using the visual analog scale (VAS). Statistical analysis was performed using t-tests, Spearman correlation, and multiple linear regression. MAIN OUTCOME MEASURES: Female sexual life satisfaction (SLS), sexual drive (SD), and general life satisfaction (GLS) were assessed using the ISL questionnaire. RESULTS: Mean ages for the 104 couples included were 62.3 and 59.8 years for the men and women, respectively. Mean ISL, SD, SLS, and GLS scores at 12 months were 25.4, 3.8, 14.1, and 7.5, respectively. ISL scores were strongly correlated with IIEF-15 domains, mainly erectile function (r > 0.41, P < 0.00002) and intercourse satisfaction (r > 0.27, P < 0.005). Age and VAS, ICIQ, and UCLA-PCI scores were negatively correlated with some ISL domains. IIEF-15 erectile function and intercourse satisfaction were the most significant domains predicting female SLS. An IIEF-15 erectile function of 25 corresponded to a 75% chance of an SLS score ≥18. CONCLUSION: Indexes of female sexual quality of life were low overall but were highly correlated with the partner's response level to IAI treatment. IAI-related pain, increased age, and poor urinary function of the male partner appear to negatively impact female sex life.

External validation of extranodal extension and lymph node density as predictors of survival in node-positive bladder cancer after radical cystectomy.

BACKGROUND: Prognostic factors in pathologic node-positive patients after radical cystectomy are debated. Extranodal extension (ENE) and lymph node density (LND) are strong predictors of survival. The aim of this study was to assess factors predictive of survival and to evaluate the prognostic significance of the tumor, node, metastasis staging system (TNM) nodal classification in a retrospective cohort of node-positive bladder cancers after radical cystectomy. METHODS: We retrospectively reviewed the data of 75 patients with node-positive bladder cancer after radical cystectomy. Node pathological examination was performed by two experienced uropathologists. Cox regression analysis was performed to identify factors predictive of progression. RESULTS: The median number of removed lymph node was 18 (range 3-49). The median number of positive lymph nodes was 3 (range 1-35). Overall progression-free and cancer-specific survival were 5 and 12 %. In multivariate analysis, ENE, LND with a 20 % cutoff, and adjuvant chemotherapy were independent predictors of progression-free survival (p = 0.007, 0.006, <0.0001). Neither the 2002 nor the 2009 TNM nodal classification was associated with recurrence. CONCLUSIONS: ENE and LND are strong predictors of clinical outcome in patients with node-positive bladder cancer treated by cystectomy. The actual TNM classification could probably be improved using these criteria, allowing better prognostic classification of node-positive bladder cancer after radical cystectomy.

Monitoring of erectile and urethral sphincter dysfunctions in a rat model mimicking radical prostatectomy damage.

INTRODUCTION: Animal models of urinary incontinence and erectile dysfunction following radical prostatectomy (RP) are lacking. AIMS: To develop an animal model of combined post-RP urethral sphincter and erectile dysfunctions, and noninvasive methods to assess erectile function (EF) and urinary sphincter function (USF) during prolonged follow-up. METHODS: In the main experiments, 60 male Sprague Dawley rats were randomized to a sham operation (N = 30) or electrocautery of both sides of the striated urethral sphincter (N = 30). EF and USF were evaluated preoperatively and on postoperative days 7, 15, 30, 60, and 90. Sphincter and penile tissue samples were evaluated histologically on days 7 (N = 10) and 30 (N = 10) to detect apoptosis (TUNEL assays) and fibrosis (Trichrome Masson staining). MAIN OUTCOME MEASURES: To assess EF, we measured systemic and penile blood flow using penile laser Doppler and penile rigidity using a durometer before and after apomorphine injection. USF was assessed based on the retrograde leak point pressure (LPPr). RESULTS: Apomorphine increased baseline Doppler flow by 180% (95% confidence interval, 156-202%) and penile hardness from 3.49 ± 0.5 to 7.16 ± 0.82 Shore A units but did not change systemic arterial flow. Mean LPPr was 76.8 ± 6.18 mm Hg at baseline and decreased by 50% after injury, with no response to apomorphine on day 7. EF and USF impairments persisted up to 90 days post injury. Histology showed penile apoptosis on day 7 and extensive urethral sphincter and penile fibrosis on day 30. Our data did not allow us to determine whether the impairment in erectile response to apomorphine preponderantly reflected arterial penile insufficiency or veno-occlusive dysfunction. CONCLUSION: Electrocautery of the striated urethral sphincter caused severe and lasting impairment of EF and USF that could be monitored repeatedly using minimally invasive methods. This new animal model may hold potential for developing new treatments designed to correct post-RP impairments.