Prospective Pilot Study: Tolerability of Outpatient Penile Plication Under Nursing-Administered Conscious Sedation vs Anesthesiologist-Administered Deep Sedation.

INTRODUCTION: Penile plication is commonly performed for Peyronie's disease under general or spinal anesthesia. Conscious sedation (CS) offers decreased anesthetic risks, cost-effectiveness, and the ability to perform the procedure in outpatient settings with shorter wait times. We sought to compare tolerability of penile plication under deep intravenous sedation (DIS) administered by anesthesiologists and nursing-administered CS (NACS). METHODS: Tolerability for penile plication was prospectively evaluated, excluding revision surgeries and those with hourglass or hinge deformities. DIS included midazolam and ketamine with infusion of propofol and remifentanil. NACS consisted of midazolam and fentanyl. Baseline characteristics, procedural information, and patient- and surgeon-reported pain assessments were collected. Patients were administered a standardized tolerability questionnaire on follow-up. RESULTS: Forty patients were enrolled (23 DIS; 17 NACS) with similar baseline characteristics. Median curvature of the DIS cohort was 55° (interquartile range = 43.75-76.25) and 45° (interquartile range = 45-60) in NACS. There was a 100% success rate with no procedure abortion or conversion to general anesthetic. On follow-up, all patients had functional curvature (<20°), and 100% of patients in the DIS and NACS cohorts reported that they would recommend CS to others. Over 93% of patients in both cohorts would choose CS over general anesthetic in the future, with no differences in perioperative and postoperative pain between groups. CONCLUSIONS: Penile plication with CS, whether administered by an anesthesiologist or nursing, is well tolerated with no differences in pain or complications. This indicates that outpatient penile plication with trained nursing staff administering CS can safely reduce costs, risks, and wait times.

Extratunical grafting for minimally invasive management of complex Peyronie's disease deformities.

BACKGROUND: Penile deformities due to Peyronie's Disease (PD) often significantly impair men's sexual health and quality of life. AIM: In this article we discuss the extratunical graft (ETG) procedure as a management strategy for PD patients with hourglass or indent penile deformities. METHODS: We compiled descriptions of surgical techniques and performed a review of the literature regarding ETG for PD. OUTCOMES: The ETG procedure appears to have promising results in the management of indent/hourglass deformity of PD. RESULTS: The findings of this review of the literature demonstrate that ETG is a safe and effective reconstructive technique for penile deformity with minimal side effects. CLINICAL IMPLICATIONS: We recommend utilizing ETG with or without plication for PD patients with indent or hourglass deformities. STRENGTHS AND LIMITATIONS: Strengths of ETG are the improvement in patients with tunical indents and hourglass deformities secondary to PD. Additionally, patients who underwent ETG maintained sexual function given no significant change in penile length and intact erectile function. Limitations, however, are that the procedure is relatively new, and data are limited to small cohorts. CONCLUSION: The ETG procedure is a safe and effective for management of complex PD in the short- and intermediate-term follow-up cohort.

Use of Soft Penile Prosthesis in Grafting Surgery for Peyronie's Disease and Mild Erectile Dysfunction: Still an Option?

BACKGROUND: Plaque incision and grafting (PEG) is a primary surgical therapy for severe penile curvature in Peyronie's disease (PD); However, it can increase the risk of erectile dysfunction (ED), particularly in patients with pre-operative mild ED. Soft penile prosthesis (SPP) implantation is a viable treatment option in such cases. This study aims to compare the outcomes of PEG-only approach to PEG plus SPP implantation. METHODS: Between 2010 and 2019, 32 patients with PD and mild ED (5-item version of the International Index of Erectile Function scores: 17-21) underwent PEG surgery. Two groups were defined based on the surgery type: PEG-only and PEG plus SPP. The long-term outcomes included correction of penile bending, erection quality, intercourse ability, penile length and sensitivity. The overall satisfaction and impact of surgery on sexual activity and quality of life were also assessed. RESULTS: Of the 32 patients, 13 (40.6%) underwent PEG-only surgery, whereas 19 (59.4%) underwent PEG plus SPP. No significant differences were noted between the groups regarding pre-operative characteristics (all p > 0.1) or intra- and post-operative complication rates (all p > 0.2). The median patch area was larger in the PEG-only group (28 cm2 vs. 16.2 cm2; p = 0.001), whereas patients in the PEG plus SPP group were more likely to receive a single patch implant (100% vs. 53.8%; p < 0.001). The penile length increased in 18 patients (61.6%), with significant differences between the two groups (30% vs. 81.2%; p = 0.03). Overall, 14 patients (53.8%) reported greater satisfaction with their sexual life post-operatively, with comparable rates between the groups (p = 0.2). No significant differences were found in the post-operative 5-item version of the International Index of Erectile Function scores or severe post-operative ED (all p > 0.5). CONCLUSIONS: SPP placement during corporoplasty in patients with mild ED is safe and feasible, and it may be a suitable option for patients uncertain about inflatable prosthesis placement. The use of SPP resulted in longer penile lengths and necessitated smaller grafts. However, further data are required to understand the long-term clinical implications of this approach.

Microscopic Electric Rotary Grinding of Plaques Combined with Graft Repair in the Management of Peyronie's Disease.

Peyronie's Disease (PD) is clinically characterized by the development of localized fibrous plaques, primarily on the tunica albuginea, especially on the dorsal area of the penis. These plaques are the hallmark feature of this condition, resulting in penile curvature, deformity, and painful erections for affected individuals. Although various nonsurgical treatment options exist, their overall effectiveness is limited. As a result, surgical intervention has become the ultimate choice for patients with severe penile curvature deformities and associated erectile dysfunction. Our research team has successfully employed a combined approach involving microscopic electric rotary grinding of the fibrous plaques and the use of tunica vaginalis or bovine pericardium as graft materials for the repairing of the defects of tunica albuginea in the treatment of PD. This approach has consistently yielded highly satisfactory results regarding the restoration of penile shape, with excellent cosmetic results and significantly improved sexual satisfaction. This protocol aims to present a comprehensive surgical management strategy utilizing electric rotary grinding of the plaques and repairing the defects of tunica albuginea by using the tunica vaginalis, which represents an optimal surgical strategy for treating PD.

Surgical management of complex curvature in Peyronie's disease.

PURPOSE: About 10% of Peyronie's patients are complex cases with severe curvature (>60 degrees), ventral plaque, multiplanar curvature, hour-glass/hinge deformity, notching deformity, and ossified plaque. In patients with complex Peyronie's disease (PD), different techniques (shortening procedures, lengthening procedures, and penile prosthesis implantation (IPP)) may be necessary to achieve successful result. This review aims to analyze the various surgical techniques employed in the management of Peyronie's disease, with a specific focus on patients with complex deformity. METHODS: Articles focusing on the surgical management of complex curvature in Peyronie's disease were searched in MEDLINE and PubMed published between 1990 and 2023. RESULTS: Shortening procedures are linked to penile shortening and are not recommended for complex cases such as notching, hour-glass deformity, or ossified plaque. Lengthening procedures are suitable for addressing complex curvatures without erectile dysfunction (ED) and are a more appropriate method for multiplanar curvatures. Penile prosthesis implantation (IPP), with or without additional procedures, is the gold standard for patients with ED and Peyronie's disease. IPP should also be the preferred option for cases of penile instability (hinge deformity) and has shown high satisfaction rates in all complex cases. CONCLUSION: While surgical interventions for complex curvature in Peyronie's disease carry inherent risks, careful patient selection, meticulous surgical techniques, and post-operative care can help minimize complications and maximize positive outcome.

Satisfaction assessment study in patients (and their partners) with/without Peyronie's disease and penile prosthesis implantation.

INTRODUCTION AND OBJECTIVE: Among the many treatments for erectile dysfunction, implantation of a penile prosthesis has been associated with high patient satisfaction rates. However, patients with coexistent Peyronie's disease (PD) and refractory erectile dysfunction and/or severe deformities may show different results. The aim of our study was to assess and to compare the level of satisfaction, with an inflatable penile prosthesis (IPP), in men with/without coexistent PD. MATERIAL AND METHODS: A survey study based on a five-item satisfaction questionnaire was submitted to all those live patients implanted in the period 1992-2022 at our center (n=570) and their partners. Ninety-two percent of implants were inflatable devices. Surgeries were mainly performed by two surgeons. The main outcome measure used was the level of patient and partner satisfaction with sexual intercourse after IPP. RESULTS: Of the 570 eligible patients, 479 (84%) completed the survey (393 Non-PD: GROUP 1; 70 non-complex PD-Group 2; 16 complex PD). Eighty-six per cent of patients in Group 1 reported satisfactory sexual intercourse (very or moderately satisfied). Non-complex PD implanted patients (Group 2) reported a global 81% satisfactory sexual intercourse (very or moderately satisfied) (p>0.05). However, when we evaluated the PD subgroup of patients with severe PD who require incision/excision/grafting at the time of implant (Group 3: n=20), only 61% reported satisfactory sexual intercourse (p<0.01) with predominance of moderately satisfied patients over very satisfied: 78% vs. 22%). Additionally, 84% (Group 1), 80% (Group 2) and 54% (Group 3) of partners reported satisfactory intercourses, respectively (p<0.01). Overall, 84% of Group 1 implants and 79% of Group 2 reported that they would undergo the procedure again if the IPP failed (p>0.05; ns). Only 50% of Group 3 patients would do it again. With regard to cosmetic aspects, 48% of the Group 3 implant reported penile shortness or soft glans as the main causes of their dissatisfaction. Only 2.4% of total PP patients expressed difficulty in manipulating the device. CONCLUSION: The presence of PD alone may not impact PP patient and partner satisfaction, but patients with more severe baseline deformity who require incision/grafting may be less satisfied with outcomes including penile length and glans sensation.

Experience With Extra-Tunical Grafting and Tunica Albuginea Plication for Correction of Indentation Deformity in Men With Peyronie's Disease.

OBJECTIVE: To further evaluate extra-tunical grafting (ETG), a relatively new surgical option to treat corporal indentation in those with Peyronie's disease without buckling or hinge effect, we report our experience, patient satisfaction, and surgical outcomes. METHODS: Retrospective review of patients following ETG, including pre-operative deformity, type of graft, graft location (under or over Buck fascia), patient characteristics, and satisfaction. Overall cosmetic satisfaction with deformity correction between patients undergoing 2 different ETG locations and 3 different types of grafts, as well as perceived bother of graft visibility and palpability were assessed. RESULTS: From 2018-2023, 35 patients underwent ETG and tunica albuginea plication (TAP) with 89.6% of patients having persistent correction on office examination at a median (interquartile range) follow-up of 23.5 (15.2) months. Overall satisfaction with penile appearance by grafting location via patient-reported questionnaires showed no statistical difference (P = .47). Patients undergoing TAP and ETG were satisfied with their erect appearance regardless of graft material. Patients reported grafting tissue was palpable (74.3%) and visible (48.6%) in the flaccid state as compared to the erect state (8.6% and 5.7%). CONCLUSION: ETG presents a less invasive surgical option than traditional approaches to correct indentation deformities not associated with instability. Our experience shows high patient satisfaction rate following correction of indentation using graft tissue when placed under or over Buck fascia. At a median follow-up of almost 2 years, patients had persistent correction, and while some report visibility of the graft and palpability in the flaccid state, this tends to disappear in the erect state.

Transdermal application of H100 gel to the penile shaft in patients with Peyronie's disease infiltrates the tunica albuginea.

Treatment options for Peyronie's disease (PD) remain limited. Topical H100 gel, (Hybrid Medical, Edina, USA), which contains nicardipine, super oxide dismutase and emu oil showed safety and efficacy in a previous small double-blind placebo-controlled pilot study. The present study evaluates if topically applied H100 gel applied to the penile shaft infiltrates the tunica albuginea. Nicardipine is a key active ingredient in H100 and serves as a surrogate marker. Three men already scheduled to undergo a planned surgical procedure for PD applied commercially available H100 gel twice daily to the penile shaft for up to 30 days prior to the procedure. Tunica albuginea samples were obtained at surgery. Nicardipine evaluation was performed using isotope dilution technique via liquid-chromatograph-mass spectrometry (LCMS). All three patients tolerated H100 gel application without side effects. All three tunica albuginea specimens showed detectable nicardipine in the tunical tissue. Transdermal application of commercially available H100 gel is able to penetrate the tunica albuginea tissue and is detectable in men with acute and chronic PD. This finding may support the encouraging results found in the prior H100 pilot study.

Grafts in Peyronie's surgery without the use of prostheses: a systematic review and meta-analysis.

Peyronie's disease (PD) is characterized by abnormal penile curvature, and various surgical methods have been developed using different graft materials. However, there is currently no universal agreement on which type of graft is the best. The objective of this review was to evaluate the available literature and identify the most effective graft material for penile curvature correction in PD. A literature search was conducted using electronic databases, including PubMed, Scopus, and the Cochrane Library. The patients, intervention, comparison, and outcome (PICO) approach was used to define the eligibility of studies. Two authors independently selected studies, evaluated them, and extracted data. Random-effect models using the DerSimonian-Laird method were used. Most studies were single-arm studies and had a high risk of bias. Buccal mucosa grafts (BMG) were found to result in the highest penile straightening rates and were associated with the least de novo erectile dysfunction. TachoSil grafts demonstrated a high success rate in straightening despite a higher mean preoperative curvature, while Tutoplast grafts had a higher incidence of postoperative erectile dysfunction. BMG had the highest percentage of postoperative penile straightening. Overall, the TachoSil graft showed the best performance when preoperative curvature is taken into account. Based on the available literature, BMG appear to be the most effective for penile curvature correction in PD, but this is offset by the requirement for low preoperative curvature. The TachoSil graft shows the best overall performance when preoperative curvature is considered. Comparative randomized clinical trials are still needed to determine graft superiority.

Long-term outcomes of extracorporeal shock wave therapy for acute Peyronie's disease: a 10-year retrospective analysis.

The aim of this paper was to describe the long-term outcomes of extracorporeal shock wave therapy (ESWT) in patients with acute Peyronie'disease (PD). An observational retrospective study was conducted in men with acute PD who underwent ESWT between 2009-2013 at a single institution. ESWT protocol consisted of 1 session (3000 shock waves, 0.10-0.25 mJ/mm^2, 4-6 Hz) per week for 4 weeks. Penile pain was chosen as the primary outcome. Penile curvature angle, erectile function, and satisfaction with ESWT were selected as secondary long-term outcomes. A total of 194 patients were included. The mean follow-up duration after ESWT was 125.6 months. Mean penile curvature worsened significantly at 3 months (18.3 vs. 21.5 degrees; p = 0.023) and 12 months (21.5 vs. 28.6 degrees; p = 0.001) and stabilized over the long-term (28.6 vs. 28.8 degrees; p = 0.335). Mean penile pain improved significantly at 3 months (6.5 vs. 3.1 points; p < 0.001) and 12 months (3.1 vs. 1.0 points; p = 0.001), remaining stable over time (1.0 vs. 1.0 points; p = 0.074). The mean five-item version of the International Index of Erectile Function (IIEF-5) increased significantly at 3 months (14.5 vs. 17.9 points; p = 0.001), remaining stable at 12 months (17.9 vs. 18.5 points; p = 0.082), and deteriorating in the long-term (18.5 vs. 15.8 points; p = 0.003). A high satisfaction rate with ESWT was recorded at 3 months (92.3%), remaining similar at 12 months (91.2%) and over the long-term (90.2%). No new acute phase and low rate of PD surgery (4.1%) were recorded in the long-term analysis. In patients with acute PD, ESWT seems to be associated with early and persistent relief of penile pain, transient improvement in erectile function, no significant effect on penile curvature, and a high rate of patient satisfaction constant over time.

A contemporary assessment of the evaluation and management of patients presenting to a tertiary medical center with Peyronie's disease.

Peyronie's disease continues to be poorly understood. We characterize the presenting features of Peyronie's disease within a large cohort and elucidate the factors that correlate with surgical intervention. Univariate and multivariate analyses were performed on 1483 consecutive patients to assess pre-operative predictors of surgical intervention for Peyronie's disease. Overall, 1263 patients met inclusion criteria. Mean age was 55.4 ± 11.1 years with a mean duration of disease at presentation of 33.2 ± 42.5 months. Mean primary curvature was 49.8 ± 20.8°. Primary ventral curvature was present in 11.4% and 36.5% of patient had a multiplanar curvature. During penile duplex ultrasound evaluation indentation/narrowing deformities were appreciated in 76.0%, hourglass deformity in 10.1%, and hinge effect in 33.0% of patients. Calcification was seen in 30.1% of patients. Operative intervention occurred in 35.3% of patients. Degree of primary curvature (1.03 OR, p < 0.001), hourglass deformity (1.82 OR, p = 0.01), decreased tunical elasticity (1.20 OR, p = 0.03), and prior intralesional collagenase clostridium histolyticum injections (2.94 OR, p < 0.001) predicted surgical correction on multivariate analysis. Compared to historical studies, we found a higher incidence of severe degree of curvature (27.5% >60°), indentation deformities, hinge-effect, multiplanar curvature and penile calcifications. Ultimately, predictors of surgical intervention included those with worse erectile function and more severe characteristics.

What do patients with Peyronie's disease expect from therapy? A prospective multi-center study.

BACKGROUND: Little is known about patients' pre-treatment expectations in Peyronie's disease (PD). OBJECTIVE: To evaluate in detail patients' expectations of conservative therapy and surgery. PATIENTS AND METHODS: This multi-center study prospectively enrolled 317 PD patients, who were scheduled to receive conservative therapy or surgery between 2019 and 2022 at the Department of Urology of the University Medical Center Hamburg-Eppendorf, and the Center of Reproductive Medicine and Andrology, University Medical Center Muenster, both Germany. The primary end-point was patients' pre-treatment expectations of conservative therapy and surgery, measured with the Stanford Expectations of Treatment Scale (SETS). Secondary end-points included patient-reported psychological and physical symptoms, penile pain, symptom bother and erectile function, measured with the Peyronie's disease questionnaire (PDQ) and International Index of Erectile Function Erectile Function Domain (IIEF-EF). RESULTS: In total, 239 (75%) and 78 (25%) patients were scheduled for the conservative therapy and surgery, respectively. Patients undergoing surgery had higher positive and negative mean SETS expectations scores (14 vs. 11, p < 0.001; 9.6 vs. 6.0, p < 0.001). In multivariable analysis, surgery was an independent predictor of positive and negative patients' pre-treatment expectations (all p ≤ 0.001). In thematic analysis, patients undergoing surgery emphasized distinct themes of pre-treatment expectations. Patients undergoing surgery had higher mean PDQ symptom bother as well as higher psychological and physical symptom scores (14 vs. 10, p < 0.001; 9.2 vs. 7.1, p = 0.001). There were significant positive correlations between SETS negative expectation score and PDQ symptom bother (|ρ| = 0.25; p < 0.001) as well as PDQ psychological and physical symptoms score, respectively (|ρ| = 0.21; p = 0.001). CONCLUSION: PD patients expect both more benefit and more harm from surgery. In addition, patients undergoing surgery have more psychological and physical symptoms and more symptom bother. To set realistic expectations, it is of pivotal importance to assess patients' expectations before starting treatment.

Risk Factors for Penile Fracture After Intralesional Collagenase Clostridium histolyticum in Peyronie's Disease.

OBJECTIVE: To evaluate risk factors leading to corporal rupture after Collagenase Clostridium histolyticum (CCh). Peyronie's disease (PD) is a fibrotic condition of the penis characterized by abnormal plaque formation. Intralesional CCh is the only FDA-approved medication for PD, however, it can lead to corporal rupture, a potential surgical emergency. METHODS: We retrospectively reviewed medical records from Veterans diagnosed with PD who were under treatment with CCh using the Veterans Administration Informatics and Computing Infrastructure (VINCI). Using International Classification of Diseases and Current Procedural Terminology codes, we identified men who suffered a corporal rupture after CCh. Individual charts were reviewed to determine potential risk factors and events leading to corporal rupture. RESULTS: We identified 17,647 veterans who were diagnosed with PD, of which 8.7% (1541) received at least one injection of CCh for PD. Of them, 0.7% (11/1541) veterans suffered corporal rupture. Within these 11 patients, the median number of CCH injections was 6 with a median initial curvature of 35°. Fracture occurred at a median of 8days after CCH injection. The majority of fractures were secondary to spontaneous erections or sexual intercourse. Finally, six patients had their fracture repaired surgically while the remaining were managed conservatively. CONCLUSION: Most fractures occurred within 2weeks of CCh injections and were associated with sexual intercourse and spontaneous morning erections.

The Discontinuation Rate With Collagenase Clostridium histolyticum for Peyronie's Disease in a High-volume Practice Is Unexpectedly High: Identifying Opportunities for Patient Care Improvement.

OBJECTIVE: To elucidate reasons for premature discontinuation of Collagenase Clostridium histolyticum (CCH) injections for the treatment of penile curvature associated with Peyronie's disease. METHODS: A database of men who underwent CCH injections at a single institution was queried to identify men who completed fewer than 8 injections. Chart review was conducted to identify reasons for treatment discontinuation. When this could not be identified, patients were contacted first via the online patient portal and next by phone. RESULTS: Of 406 patients who underwent CCH treatment, 133 did not complete 8 injections (32.8%). The most common reasons for discontinuation were satisfactory curve reduction (27%), unsatisfactory curve reduction (21%), bothersome side effect (15%), and pursuit of surgery (12%). Other less common reasons included other health concerns, pausing treatment due to the COVID-19 pandemic, high cost, transferring care elsewhere, and lack of awareness that more injections were indicated. CONCLUSION: We present the largest series of patients to date dedicated to evaluation of CCH discontinuation. We find that up to 1/3 of patients who begin CCH injections will not complete the full treatment course. Understanding the reasons for discontinuation can help providers better stratify patients for CCH treatment vs other modalities. In addition, as previous studies indicate curvature improvements are equally likely to be seen in the final four injections as the first four, our data points to the potential impact of improved patient education for individuals who discontinue due to unsatisfactory curve reduction.

Treatment with stromal vascular fraction of Peyronie's disease - a study protocol.

INTRODUCTION: Peyronie´s disease is the result of an acquired fibrotic plaque in the tunica albuginea. It remains unknown why the condition appears, but it seems to affect up to 9% of all men. It can result in a debilitating curvature of the erect penis, which has extensive impact on the quality of life for many men. Thus, the disease may result in low self-esteem, depression and impaired sexual performance. METHODS: This is a prospective pilot study investigating the feasibility and safety of stromal vascular fraction injection into the plaque of 22 men with Peyronie´s disease in the chronic phase. The stromal vascular fraction is obtained from a small liposuction of 250 ml fat in general anaesthesia and injected the same day. CONCLUSION: We hope to show that injection of stromal vascular fraction is safe and effective in reducing curvature in men with Peyronie´s disease. FUNDING: The study was made possible with funding from: the Region of Southern Denmark, Louis-Hansen Fund, Lizzi and Mogens Staal Fund, Karola Jørgensen Fund, Marie and Børge Kroghs Fund, the Senior Doctors Research Fund OUH, the Fund for gentle Surgery OUH and the PhD fund of the executive board of the South West Denmark Hospital. The funding sources had no influence on the trial design, data collection, analysis or publication. CLINICALTRIALS: gov NCT04771442, EudraCT 2020-004297-22, Danish Medicines Agency 2020090057, National Ethics Committee 74705 and Danish Data Protection Agency (record no. 1/21757).

Perspective: Residual penile curvature correction during penile prosthesis implantation by plication in Peyronie's patients.

For patients with large calcified tunical plaque or severe corporal fibrosis which are likely to have a pronounced and persistent residual curvature which may not be correct by penile prosthesis implantation alone, other adjunctive manoeuvres such as penile plication and/or plaque incision with grafting may be necessary. The sequence between penile plication and penile prosthesis implantation is largely dependent on several factors such as the severity of penile curvature, the presence of (calcified) tunical plaque(s) and whether aggressive corporal dilation and subsequent penile remodelling with an inflated implant can straighten any residual penis curvature. The advantages of pre-placement of penile plication sutures prior to penile prosthesis implantation are the avoidance of inadvertent damage to the underlying penile prosthesis implant, the ability to adjust the tension on the rows of the plication sutures based on residual curvature with the device fully inflated, and potentially minimising the duration of surgery. In contrast, penile prosthesis implantation followed by penile plication to correct residual curvature, this sequence of surgery may negate the need for penile plications if penile remodelling is effective, or the residual curvature is less than 15 degrees where postoperative manual remodelling may continue to improve the penile cosmesis. When performed by expert surgeons and adhering to safe surgical principles, there is no doubt that patients will be satisfied with the outcomes and highly appreciative of the final penile cosmesis and the ensuing optimal outcomes.