Malleable Penile Prosthesis Implantation Research Articles

(105) Arab Patient and Partner Satisfaction Following Malleable Penile Prosthesis Implantation in North Africa and the Middle East

Abstract Introduction Due to the sensitivity of the topic of penile implants for the treatment of refractory erectile dysfunction (ED) in the Middle East and North Africa region, a scarce body of related research is available. Objective We aimed at investigating the levels of patient and partner satisfaction after malleable penile prosthesis implantation among the Arab population and its dynamics during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing malleable penile prosthesis implantation at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). We utilized our validated Arabic version of the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (AM-EDITS). During the 1st first encounter, we inquired about the general patient perioperative experience, starting from preoperative counseling till the first month after surgery. The 2nd and 3rd encounters focused on patient and partner satisfaction after implant utilization. Results The average ages of the men and their partners were 54.7±8.4 and 32.9±4.6 years, respectively. Levels of anxiety decreased in over 82% of the men in our study upon receiving proper preoperative counseling. Almost all of the patients were happy (96%) with their early PO days with over 50% of them exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied partners at 3 months, nearly 80% were highly satisfied. Over 93% of them reported feeling sexually desirable by their husbands. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P < 0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P < 0.001), respectively, compared to the 3 months follow up. Conclusions Malleable penile implants still represent a good quality-of-life treatment option for middle to low-income countries. Time has a positive effect on Arab men’s PO satisfaction as opposed to their partners’. The explanation behind these findings should be investigated in further studies. A proper understanding of the dynamics of patient and partner satisfaction over time may be useful for proper perioperative counseling of both parties to ensure their sustainable satisfaction. Disclosure No.

(021) Eight-Dot Extended Corporotomy versus Conventional Corporotomy for Malleable Penile Prosthesis Implantation

Abstract Introduction To date, malleable type penile prosthesis implantation (MPPI) remains the more popular in developing countries, owing to its relative economic cost. Despite the simplicity of the procedure, there still may be areas of improvement and refinement to optimize procedure efficiency and accuracy subsequently improving postoperative outcomes while reducing complication risk. Objective We aimed to compare the eight-dot extended corporotomy and the conventional corporotomy techniques for MPPI with regard to operative time and postoperative complications. Methods We conducted a prospective randomized interventional clinical study on 51 subjects. Patients were randomized into 2 groups: the eight-dot group (n=27) and the conventional group (n=24). The eight-dot group underwent MPPI using the eight-dot extended corporotomy as previously described (VJPU - Eight-dot Extended Corporotomy: A More Secure, Aesthetic and Time Efficient Technique for Semirigid Penile Prosthesis Implantation, n.d.). The conventional group underwent MPPI using conventional limited corporotomies that were closed via continuous running sutures. We compared both groups in terms of corporotomy opening to closure time, overall procedure time, and perioperative complications. The follow-up period was 3 months. Results Upon timing in seconds (s), a significant time difference between the 2 groups was demonstrated for suture placement, corporotomy incision and implant placement, corporotomy closure, and total procedure duration. Although patients in the eight-dot group required a longer time for suture placement vs the conventional group (486 vs 201 s, respectively, p < 0.001), the durations for the remaining implantation steps, as well as the whole procedure, were significantly shorter for the former group. Corporotomy opening followed by implant placement took significantly less time for the eight-dot group (1090 s) vs the conventional group (1313 s), p <0.001. Moreover, insertion of implant rods was subjectively easier with no need for aggressive bending owing to the extended corporotomy length. Similarly, corporotomy closure using the 8-dot technique was 10.13 minutes swifter than the conventional group (220 s vs. 828 s, respectively, p < 0.001). The total procedure length was over 8 minutes shorter for the eight-dot group as opposed to the conventional group (2527 vs 3027 s, respectively, p < 0.001). In terms of postoperative complications in the form of pain, swelling, hematoma, and infection, there were no significant differences between both groups. Conclusions The eight-dot extended corporotomy technique is a safe and time-saving approach compared to the conventional limited corporotomy technique, making the MPPI procedure more efficient. A swifter procedure decreases both patient exposure to anesthesia and device exposure to air which in turn lowers the risk for potential postoperative complications. Disclosure No.

(388) Arab Patient and Partner Satisfaction Following Malleable Penile Prosthesis Implantation in the Middle East and North Africa

Abstract Introduction Due to the sensitivity of the topic of penile implants for the treatment of refractory erectile dysfunction (ED) in the Middle East and North Africa region, a scarce body of related research is available. Objective We aimed at investigating the levels of patient and partner satisfaction after malleable penile prosthesis implantation among the Arab population and its dynamics during and after the first 6 months of surgery. Methods This was a prospective 6-month follow-up study of 120 patients undergoing malleable penile prosthesis implantation at our unit by a single surgeon. Three telephone encounters were conducted for each couple at 1 month, 3 months, and 6 months postoperative (PO). We utilized our validated Arabic version of the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (AM-EDITS). During the 1st first encounter, we inquired about the general patient perioperative experience, starting from preoperative counseling till the first month after surgery. The 2nd and 3rd encounters focused on patient and partner satisfaction after implant utilization. Results The average ages of the men and their partners were 54.7±8.4 and 32.9±4.6 years, respectively. Levels of anxiety decreased in over 82% of the men in our study upon receiving proper preoperative counseling. Almost all of the patients were happy (96%) with their early PO days with over 50% of them exceeding their expectations. After 3 months, 82.5% of the men were satisfied, describing their erections to be 80% close to natural. Of the 92.5% satisfied partners at 3 months, nearly 80% were highly satisfied. Over 93% of them reported feeling sexually desirable by their husbands. As opposed to the significant rise in men’s overall satisfaction and AM-EDITS index by 11.6% and 5.2 ± 0.8% (P < 0.001), respectively after 6 months PO, partners demonstrated a 12.4% and 5.9 ± 0.8 decline (P < 0.001), respectively, compared to the 3 months follow up. Conclusions Malleable penile implants still represent a good quality of life treatment option for middle to low-income countries. Time has a positive effect on Arab men’s PO satisfaction as opposed to their partners’. The explanation behind these findings should be investigated in further studies. A proper understanding of the dynamics of patient and partner satisfaction over time may be useful for proper perioperative counseling of both parties to ensure their sustainable satisfaction. Disclosure No.

The Efficacy of Suspensory Ligament Release and Pubic Lipectomy Via Penopubic Z Plasty During Penile Prosthesis Implantation in Improving Sexual Satisfaction: A Prospective Randomized Controlled Trial

The utility of penile suspensory ligament release (SLR) in the setting of penile prosthesis implantation (PPI) has received limited attention in the literature. To assess the efficacy and safety of penile SLR release, pubic lipectomy (PL), and the utility of penopubic Z-plasty (ZP) during malleable PPI in improving sexual satisfaction compared to that achieved with the conventional method. Between August 2018 and April 2020, 61 patients with refractory erectile dysfunction were prospectively randomized into 2 groups; group A included 31 patients who underwent PPI with SLR and PL via ZP, and group B included 30 patients who underwent conventional PPI via a penoscrotal incision. Penile length was assessed at 3 months, and sexual satisfaction was assessed up to 1 year after PPI using both validated and non-validated tools. The median operative time was higher in group A than in group B (170 min; interquartile range [IQR] [160-190] vs 97.5 min; IQR [90-110] P < .001).The median pre- to postoperative differences in functional and visible penile lengths for group A were 1.5 cm; IQR [0-2] and 2.5 cm; IQR [1-3.5], respectively, while those in group B were both 0 cm; IQR [-1 to 0] P < .001). Group A patients reported higher scores in the International Index of Erectile Function satisfaction domains than the group B patients did (13; IQR [12-14] and 9; IQR [8-10] vs 11; IQR [9.5-12] and 8; IQR [6.5-8.5], respectively, P < .001). Moreover, the postoperative Erectile Dysfunction Inventory of Treatment Satisfaction score was higher in group A than that in group B (95.40; IQR [91-97.7] vs 85.20; IQR [72.7-91], respectively, P < .001). Common complications in group A were penile edema (77.4%), penile instability (9.7%) and glans numbness (9.7%). The benefit in patient satisfaction following SLR and PL via ZP during PPI may outweigh the incremental increase in complications. To our knowledge, this is the first prospective randomized controlled study to evaluate the efficacy and safety of SLR, PL, and ZP during PPI. However, because an optimal tool for assessing sexual satisfaction after PPI is lacking at this time, we alternatively adopted the most used assessment tools. Further, our data applies only to malleable penile prosthesis. SLR and PL via ZP during PPI resulted in a substantial improvement of the patients' sexual satisfaction without serious complications.

Can malleable penile prosthesis implantation improve voiding dysfunction in men with concurrent erectile dysfunction and buried penis?

PurposeA buried penis causes voiding dysfunction and limits penetrative sexual intercourse. This pilot study evaluates the urinary outcomes in men with buried penis following insertion of malleable penile implants.Materials and MethodsMen with buried penis and co-existing urinary problems and erectile dysfunction underwent malleable penile prosthesis implantation were reviewed in a prospective ethics approved database. Patient demographics, flow rate (Qmax), International Prostate Symptom Score (IPSS), Patient Global Impression of Improvement (PGI-I) score, International Index of Erectile Function (IIEF)-5 score, Sexual Encounter Profile (SEP) and overall satisfaction score (on a 5-point scale) were recorded.ResultsA total of 12 men (age 55 to 72 years) were reviewed, and the average gain in penile length post-implant, as measured from the pubis to the tip of the glans penis, was 6.8 (3 to 8) cm. There was a significant improvement in IIEF-5 score (8.2 vs. 22.5; p=0.029) post-implant, and more than half of patients were able to resume normal sexual intercourse and positive SEP-2 and SEP-4 were reported in 9 (75%) and 8 (67%) patients. There were no significant intraoperative or postoperative complication. Significant improvement in Qmax (8.4 ml/s vs. 18.6 ml/s; p=0.042) and IPSS (24.5±5.5 vs 15.5±3.5; p=0.038) were observed. More than two-thirds (83%) reported PGI-I score at 1 or 2, while 9 (75%) patients scored a 5/5 in overall satisfaction rate.ConclusionsMalleable penile implants increases penile length and improves urinary function in a highly select group of men with a buried penis and erectile dysfunction.

Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation

IntroductionSpontaneous penile tumescence after penile prosthesis implantation has been sporadically reported in the literature. AimTo preserve residual erectile function of patients’ spontaneous penile tumescence by sparing cavernous tissue in the course of malleable penile prosthesis implantation. MethodsOverall, 92 patients were randomized into 2 equal arms; patients undergoing conventional malleable penile prosthesis implantation, and patients undergoing the cavernous tissue–sparing technique. 1 month after surgery, these patients underwent penile duplex examination to assess the maximal cavernous tissue thickness around the implant cylinders. Additionally, they were asked about the occurrence of any spontaneous or arousal-induced penile tumescence. Main Outcome MeasuresPostoperative changes were compared with the preoperative ones. ResultsThe mean maximal cavernous tissue thickness was shown to be significantly higher in the cavernous tissue–sparing group compared with the conventional surgery group (5.2 ± 0.8 mm vs 2.2 ± 1.04 mm, P < .01). In the cavernous tissue–sparing group, 41 of 46 patients (89.13%) reported having a significantly higher incidence of residual penile tumescence vs 7 of 46 patients (15.2%) in the conventional surgery group (P < .001). The postoperative penile girth was significantly higher in the cavernous tissue–sparing group than in the conventional surgery group (11.16 ± 1.1 cm vs 10.11 ± 1.15 cm, P < .001). Clinical ImplicationsThis study provides a step-by-step approach to maintaining post-implantation penile tumescence and preserving penile girth in a reproducible manner. Strengths & LimitationsThis is the first study to demonstrate the benefits of implanting a penile prosthesis while the penis is in a pharmacologically induced tumescent state. It is also the first to make use of ultrasound imaging in assessing postoperative corporal tissue. The main limitations are the short postoperative follow-up period and the non-blinding of measurements. ConclusionIt could be concluded that the cavernous tissue–sparing technique is a reproducible technique that has the added value of preserving residual erectile function in the form of retained postoperative penile tumescence and preserved penile girth.Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med 2019;16:474–478.

222 Beyond the Bench: Surgical Technique Development for Implantation of a Novel Penile Prosthesis in Human Corpora Cavernosa

With development of a novel class of penile prosthesis that uses shape memory alloys (SMA), we sought to develop and troubleshoot the optimal surgical technique for implantation into the corpora cavernosa of human cadavers as no established technique exists. Development of such surgical techniques is necessary to move forward to human applications. Two pelvic human cadavers were obtained. A lasercut SMA prosthesis that has been previously described surrounding a spongy core and covered in a latex sheath was inserted into the corpora cavernosa through various established surgical approaches: (1) transglanular, (2) subcoronal, and (3) penoscrotal. Challenges in technique were documented and activation/deactivation of the device was carried out. Similar to malleable penile prosthesis implantation, techniques for inserting a cylindrical device involved creating a space in the corpora using standard dilation techniques. Unlike malleables, we are able to crimp our device and reduce cross sectional diameter prior to implantation. The numerous ribs in our prototype, despite being encased in a latex sheath, made implantation from a distal approach (transglanular and subcoronal) challenging. A penoscrotal approach was more successful. Seating the prototype into the proximal crura was also difficult, as our prototype did not have rear tip extenders or proximal tapering. Fixation proximally was found to be important for stability. During the activation process with magnetic induction, the intrapelvic portion was difficult to access, while the penile component responded readily and demonstrated a force resistant to buckling of 1.2 kgf.

Long-term outcomes of AMS Spectra® penile prosthesis implantation and satisfaction rates.

The aim of this study was to evaluate the surgical implantation techniques of AMS Spectra malleable penile prosthesis, its intraoperative and postoperative complications, and the rates of patient and partner satisfaction. Forty-six patients on whom AMS Spectra malleable penile prosthesis implantation was performed between 2009 and 2014 were retrospectively examined. Any complications seen intraoperatively and postoperatively were determined. International Index of Erectile Function (IIEF)-5, total IIEF erectile function domain scores were calculated preoperatively. IIEF-5, total IIEF erectile function domain and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were calculated in the postoperative third, sixth and twelfth months. The mean age of the patients was 63.6±7.28 (38-80) years. The mean erectile dysfunction period was 4.29±2.51 years, and the mean follow-up period was 3.19±1.6 years. The mean IIEF-5 score was 5.86±0.92 before surgery, and it was 22.5±0.62 at the end of the follow-up. The mean total IIEF erectile function domain score was 6.02±1.09 before surgery, and it was 26.02±0.21 at the end of the follow-up. The mean EDITS score was 71.06±3.16 at the end of the follow-up. The mean EDITS score of the patients partners was 65.08±4.34 at the end of the follow-up. The overall satisfaction rates were 96.2% for the patients and 84.6% for the partners. As a result of this study, the AMS Spectra penile prosthesis implantation is an effective, reliable and economic method. It can be used in the treatment of erectile dysfunction in selected patient groups offering high patient and partner satisfaction rates.

Management of Ischemic Priapism by Penile Prosthesis Insertion: Prevention of Distal Erosion

Refractory ischemic priapism results in cavernous smooth muscle necrosis, fibrosis and eventual penile shortening. Immediate penile implant insertion for acute ischemic priapism is done to avoid consequent fibrosis and shortening but ineffective shunt surgery trials may lead to potential weakness and erosion at the corporeal tip. We evaluate nonabsorbable sling sutures to fix the implant cylinder in place and prevent protrusion through the weak corporeal tip. We prospectively evaluated 12 men who presented with prolonged refractory ischemic priapism a median of 120 hours (range 60 to 168) in duration. All patients were unresponsive to conventional treatment and 11 had undergone unsuccessful shunt surgery. Early malleable penile prosthesis implantation had been done in all cases. To avoid possible distal protrusion a nonabsorbable sling suture was taken through the cylinder and the edges of the opened tunicae albuginea to fix the cylinder to the corporotomy edges. Penile implants were successfully inserted in all patients. No intraoperative or early postoperative complications were noted except in 1 with sickle cell priapism, in whom dilation led to unilateral corporeal perforation, which was managed intraoperatively. All patients were satisfied with the surgical results. No distal erosion was noted through the weak corporeal tip. No postoperative infection was reported at a median followup of 15 months (range 6 to 36). All patients successfully achieved sexual intercourse. Early penile prosthesis insertion for acute ischemic priapism is simple and successful. Distal cylinder protrusion through the defective corpora due to previous shunt surgery remains to confound surgical success. Nonabsorbable sling suture of the cylinder to the tunica albuginea is effective, simple and safe treatment for this formidable complication.

Gangrene of the distal penis after implantation of malleable penile prosthesis in a diabetic patient

We present a rare clinical case of distal penile gangrene in a patient with type 2 diabetes mellitus after the implantation of malleable penile prosthesis. Necrosis of the glans penis, urethral meatus, dorsal penile shaft, and corpora cavernosa was observed, and a distal penectomy was performed.

Penile Reconstruction by the Free Scapular Flap and Malleable Penis Prosthesis

: Penile reconstruction has always been a challenging problem for plastic surgeons while facing patients with severe congenital deformities and gender dysphoria and those who have suffered penile loss because of trauma, self-amputation, malignancy, and so on. Since 1936, when Bogoras first constructed a total penis, attempts have been made by different techniques, including skin flaps or myocutaneous flaps. And with development of free tissue transfer and microsurgical techniques, various free skin flaps, such as the radial free forearm flap, the superficial inferior epigastric artery flap, the superficial circumflex iliac artery flap, have been attempted for phallic construction, with the goal of functional (including a competent neourethra that allows voiding while standing and sexual intercourse) and cosmetic result. The purpose of our study was to evaluate the scapular free flap and implantation of malleable penile prosthesis for penile reconstruction. : Since March 2000, 20 patients with penile loss were reconstructed in a 1-stage procedure by transferring scapular flap and implantation of a malleable penile prosthesis. The age of the patients ranged between 21 and 36 years old. Of these patients, 12 had penile amputation resulting from an electric accident; the other 8 were self-amputated. : All the flaps remained 100% viable postoperatively. Follow-up ranged from 1 to 5 years. There were no cases of urethral fistula, urethral stenosis, prosthesis extrusion, or infection. The reconstructed penis yielded satisfactory function and esthetic appearance. : The scapular free flap is an ideal flap that achieves satisfactory function and esthetic appearance for penile reconstruction because of its adequate amount of tissue, reliable vascularity, acceptable donor-site morbidity, and reliable blood supply.

Prospective long-term results and quality-of-life assessment after Dura-II penile prosthesis placement

Objectives To evaluate prospectively the long-term device reliability and patient satisfaction after Dura-II malleable penile prosthesis implantation. Methods Between 1992 and 1996, 94 patients underwent Dura-II implantation for erectile dysfunction. Patients were prospectively examined and completed standardized questionnaires regarding sexual activity, prosthesis function, intercourse satisfaction, and overall quality of life. An independent statistician analyzed these data. Results The mean patient age was 63 years, and the mean patient follow-up was 5.7 years. Eighty-five patients were available for long-term evaluation. Fourteen patients died during the follow-up period. One patient was lost to follow-up, and eight prostheses (9%) were explanted; however, no mechanical defects were found in the explanted prostheses. Seventy-six percent and 87% of patients reported satisfactory rigidity and ease of concealing the device, respectively. Seventy-six percent of patients remained sexually active during the evaluation period, and 87% of patients reported that the prosthesis improved their overall quality of life. Eighty-five percent would undergo the implant surgery again, and 88% percent of patients would recommend the Dura-II prosthesis to a friend. Conclusions The Dura-II malleable penile prosthesis provides good rigidity, ability to conceal the device, and mechanical reliability, as demonstrated by the results of this long-term study. Most patients stated they would have the prosthesis placed again and would recommend it to a friend.