Traction Therapy Research Articles

The corporoplasty of Peyronie’s disease with the xenograft and the synthetic graft

The study objective is the demonstration of innovative surgical technologies of performing reconstructive plastic surgery on the penis using the grafts and also analysis of the results of treatment. Materials and methods . The reconstructive plastic surgery was performed in 28patients with Peyronie’s disease (erectile deformity of the penis more than 30°). It was the grafting of the tunica albuginea of the penis. In 6 cases the xenopericardium was used and in 22 cases — the synthetic biomaterial. The exposure of the circumcisio was performed with the excision of the fibrous plaque of the penile tunica albuginea with the replacement of the defect with the graft to 20 cm 2 in area. Results. In 1, 3 and 6 months after surgery all patients (100 %) had no regrets about surgical treatment. We had no cases of infection or rejection of the xenograft and synthetic graft. In 3 and 6 months after surgery, 25 and 35.7 % of patients, respectively, reported the lengthening of the penis during erection, which we associate with the use of traction therapy after complete wound healing. International Index of Erectile Function increased in 3 and 6 months after surgery. In 3 (10.7 %) cases there was a residual curvature (<30°), which disappeared almost completely in 6 months after the surgery. In 2 cases, there was a shortening of the penis to 2 cm and its deviation to 30° after corporoplasty with xenograft. Conclusion. The use of the xenopericardium provides an excellent result du to its strength, biocompatibility, variety of sizes (up to 144 cm 2 ), and the absence of pronouncedfibro-sclerotic restructuring of surrounding tissues.

PS-05-011 The multimodal treatment for acute phase Peyronie Disease

to present our experience with multimodal therapy for Peyronie Disease Retrospective data were collected since 2008 to 2017. The following features were evaluated at baseline and after treatment: age, duration of disease, erectile function (EF), erected penile curvature (EPC), stretched penile length (SPL). All patients were offered the same protocol including: 12 intralesional verapamil injections (IVIs); Oral therapy (OT): L-arginine 2 grams once and pentoxifylline 400 mg three times a day for 6 months; penile traction therapy. The adherence to each of the three component of multimodal treatment was evaluated . 177 individuals were considered. Depending on the grade of adherence our survey was divided into three groups. Group one: patients who only completed OT; Group two: men who accomplished OT and IVIs; Group three: patients who completed the entire protocol. 76 ,45 and 56 men were assigned to group one, two and three respectively. The mean age at the diagnosis was 59 (±8,4), 59,1 (±5,9) and 54,2 (±4,8) years, while the mean duration of the disease was 6,3(±3,4) , 4,8(±2,9) and 3,9 (±3,1) months in group one, two and three. The EPC before and after treatment was 24,2°(±9) and 23,7°(±8,9) in group one (p<0,36) ; 25,4° (±16,8) and 24,1° (±13,6) in group two (p<0,34) , 34,3° (±17,9) and 26,1° (±17,2) in group three (p<0,001).

A multi-body model for comparative study of cervical traction simulation – comparison between inclined and sitting traction

A computer simulation model was developed to compare the result of cervical traction therapy in inclined and sitting traction positions. The behavior of the model was shown to match with the intervertebral changes in the upper and lower spine from the data of a radiographic experiment. Both the results of the experiment and the simulation also showed that in the inclined position, the amount of posterior separations in the upper cervical spine remains constant regardless of traction angle, while the posterior separations at lower cervical spine increases along with traction angles. Using the simulation model, parametric studies were conducted to investigate the intervertebral space changes in response to different traction angles in the inclined and sitting positions. When using the sitting position, the subject’s hip joint stiffness was shown to cause larger variations in the intervertebral space than in the inclined position. In addition, variations in the tension/compression stiffness was shown to cause the largest changes in the resulting separations in both positions but the variations in anterior space changes were larger in the sitting position. Our study suggests that the inclined position is less sensitive to variations in the subject's body parameters and is able to provide a more reliable and predictable traction result than the sitting position.

Ten-year experience with multimodal treatment for acute phase Peyronie's disease: A real life clinical report

ObjectivesTo present our experience with multimodal therapy for Peyronie's disease. MethodsRetrospective data were collected since 2008–2017. The following features were evaluated at baseline and after treatment: age, duration of disease, erectile function, erected penile curvature, and stretched penile length. All patients were offered the same protocol including: 12 intralesional verapamil injections, oral therapy (OT) ‒ l-arginine 2 g once and pentoxifylline 400mg 3 times a day for 6 months ‒ and penile traction therapy. The adherence to each of the 3 components of multimodal treatment was evaluated. ResultsOne hundred and seventy-seven individuals were considered. Depending on the grade of adherence our survey was divided into 3 groups. Group 1: patients who only completed OT; group 2: men who accomplished OT and intralesional verapamil injections; group 3: patients who completed the entire protocol. Seventy-six, 45 and 56 men were assigned to group 1, 2 and 3 respectively. The mean age at the diagnosis was 59±8.4, 59.1±5.9 and 54.2±4.8 years, while the mean duration of the disease was 6.3±3.4, 4.8±2.9 and 3.9±3.1 months in group 1, 2 and 3. The erected penile curvature before and after treatment was 24.2±9 and 23.7±8.9° in group 1 (p<0.36); 25.4±16.8 and 24.1±13.6° in group 2 (p<0.34), and 34.3±17.9 and 26.1±17.2° in group 3 (p<0.001). ConclusionsOT alone was successful to block the progression of the disease. The add of intralesional verapamil injections to OT brought only mild improvements. The complete protocol significantly reduced erected penile curvature and improved erectile function.

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

BackgroundPrevious studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie’s disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. AimTo assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices. MethodsA prospective registry has been maintained of all men undergoing CCH injections for PD between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX). OutcomesChanges in penile length, curvature, and subjective perception and the occurrence of adverse events. ResultsOf 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous PD medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups. Clinical ImplicationsUse of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with PD receiving CCH therapy. Strengths & LimitationsStudy strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting. ConclusionThe combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices.Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease. J Sex Med 2019;16:891–900.

PD21-02 IMPACT OF PENILE TRACTION THERAPY ON ERECTILE DYSFUNCTION IN A COHORT OF MEN WITH PEYRONIE’S DISEASE

INTRODUCTION AND OBJECTIVES:Several studies have demonstrated improvements in erectile function (EF) among Peyronie's disease (PD) men undergoing penile traction therapy (PTT). However, no randomiz...

A multi-body model for comparative study of cervical traction simulation – development, improvement and validation

A computer simulation model was developed to study the dynamic behavior of the cervical spine during cervical traction therapy in inclined and sitting traction positions. The model improved upon an old model with additional components to represent the behavior of the intervertebral discs and the posterior ligaments. The simulation result of the new model was compared against the cervical traction data from a radiographic experiment in both positions. The simulation results of the old model and new model were compared to illustrate the improvement. Using the new model, we compared the timing response of cervical traction in the inclined and sitting positions.

117 The Effect of Adjunct Mechanical Traction on Penile Length in Men Undergoing Primary Treatment for Peyronie's Disease: A Systematic Review and Meta-analysis

Penile length loss is a common complaint of men with Peyronie’s disease (PD), and sometimes progresses after treatment for PD. Mechanical penile traction is a non-invasive option before or after primary therapy to preserve length; however, data on the efficacy of traction therapy is conflicting. A systematic review and meta-analysis was performed to assess the effect of penile traction on 1) stretched penile length (SPL) and 2) erect penile curvature (EPC) after primary treatment for men with PD. A systematic search of MEDLINE, EMBASE, CENTRAL, and Clinicaltrial.gov was performed for studies published through January 2018 that evaluated the correction of PD curve using penile traction as a secondary treatment. Studies were included if 1) a singular primary treatment of PD (injection or surgical treatment) was performed for all included men, 2) if there was a control group with no adjunct traction, and 3) if patients were required to wear the traction device for greater than two hours per day. Estimates were pooled using random-effects meta-analysis. Two primary outcomes were assessed: change in SPL and change in EPC.

106 Cost Effectiveness of Peyronie’s Disease Therapies: A Comparison of RestoreX Penile Traction Therapy, Collagenase Clostridium Histolyticum, and Surgery

A novel penile traction therapy (PTT) device, RestoreX, has recently been suggested as a potential minimally-invasive therapy for the management of Peyronie’s disease (PD). Given the current medical environment of value-based care and cost containment, we sought to compare PTT with RestoreX to other standard PD therapies to evaluate for efficacy, adverse events, and cost-effectiveness. To directly compare RestoreX PTT (RxPTT) against collagenase clostridium histolyticum (CCH) and surgery (penile plication or incision and grafting [I&G]) using a cost-effectiveness model among men with PD. A decision analytic model was created to compare the cost-effectiveness of treatment with RxPTT versus CCH versus penile plication or I&G. Cost-effective models account for actual costs, costs of complications, and impact of complications on overall quality of life (QALY). Outcomes were derived from prospective or randomized databases of 78 patients treated with regular use of a novel traction device, 192 patients undergoing CCH, and 23 patients treated with plication or I&G. Data included baseline patient and disease characteristics, complications, and outcomes for each modality. Costs were derived from our hospital financial department and utility values from the literature. For the base-case primary analysis, success was defined as ≥20% improvement in curvature. Two secondary analyses were performed with success defined as restoration of penetration and a final absolute curvature ≤20°. We reported incremental costs and incremental effectiveness for each treatment option, and performed a sensitivity analysis by varying each input value across a set range.

107 Efficacy of Combined Xiaflex and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

107 Efficacy of Combined Xiaflex and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

165 Impact of Penile Traction Therapy on Erectile Dysfunction in a Cohort of Men with Peyronie's Disease

Several studies have previously demonstrated improvements in erectile function among Peyronie’s disease (PD) men undergoing penile traction therapy (PTT). However, to date, no randomized controlled trials have confirmed this finding or attempted to differentiate the changes in erectile function from improvements in curvature. To identify the impact of PTT on erectile function, independent of improvements in penile curvature or length in a PD cohort. A randomized, controlled trial (NCT03389854) is ongoing to evaluate the impact of PTT with RestoreX in 120 men with PD. Men are randomized to one of four groupings: no therapy (control) or treatment with Restorex for 30 minutes 1x, 2x, or 3x daily for 3 months. All men then enter an open label phase for an additional 3 months. Inclusion criteria are no current or recent PD therapies and ≥30 degrees curvature. The primary outcome is safety, and secondary outcomes include penile length, curvature, and subjective responses to standardized and non-standardized questionnaires. Assessments are obtained at baseline and 3 and 6 months after starting therapy. To specifically evaluate erectile function, patients were administered the International Index of Erectile Function Questionnaire and SEP2 and SEP3. Additionally, given the difficulty in differentiating improvements in erectile function from changes in PD, patients were asked the non-standardized question, “has the treatment you have been taking improved your erectile function?”

274 Outcomes Of Intralesional Collagenase Clostridium Histolyticum (CCH) In Peyronie’s Disease

The IMPRESS trials estimated that 75% of men will experience 25% curvature improvement with a mean of a 30% curvature improvement. To describe our experience and define predictors of improvement. We retrospectively reviewed records of men with PD who underwent CCH treatment. Men received up to 8 injections of CCH, divided into 4 cycles. Patients underwent a baseline, interim (between cycles 2 and 3) and end-of-treatment (EOT) curvature assessment (CA). CA were performed in the office using goniometry after a pharmacologically-induced rigid erection. 2 hours of daily traction therapy was used to standardized mechanical therapy. Patient demographics, PD characteristics and outcomes were recorded. Two different definitions of curvature improvement were used: absolute change (10o) and percentage change (>25%). Three categories degrees of response were evaluated: improvement (>10o), unchanged (±10o) or worsened (>10o). Multivariable analysis (MVA) was performed to explore predictors of improvement. Sub-group analysis was performed to evaluate improvement rates in groups with different baseline curvature: group A <30°, B 30–60° and C >60°.

170 6-month Outcomes of RestoreX Penile Traction Therapy in Men with Peyronie's Disease: A Randomized, Controlled Trial

A randomized, controlled trial is ongoing to evaluate the efficacy of a novel penile traction therapy (PTT) device, RestoreX, on outcomes of men with PD. Prior PTT devices have demonstrated notable shortcomings, including a need for 5 hours or more daily to achieve outcomes. Additionally, this study represents the first randomized, controlled trial evaluating the efficacy of PTT in men with PD. To report preliminary 6-month outcomes of PTT with RestoreX in men with PD. A randomized, controlled trial (NCT03389854) is being conducted to evaluate the impact of PTT with RestoreX in 120 men with PD. Men are randomized to one of four groupings: no therapy (control) or treatment with Restorex for 30 minutes 1x, 2x, or 3x daily for 3 months. All men then enter an open label phase for an additional 3 months. Inclusion criteria are no current or recent PD therapies and ≥30 degrees curvature. The primary outcome is safety, and secondary outcomes include penile length, curvature, and subjective responses to standardized (IIEF, PDQ) and non-standardized questionnaires. Assessments are obtained at baseline and 3 and 6 months after starting therapy.

Mechanism design and kinematics analysis of multifunctional waist rehabilitation bed

A multifunctional waist rehabilitation bed is designed for the traction therapy of human spine and gait rehabilitation training. The rehabilitation bed has four degrees of freedom, the rotation in the x, y, and z axis, and the movement in the z axis, which realizes traction treatment of lumbar spine rotation around coronal axis, vertical axis, sagittal axis and gait rehabilitation training. Considering the stability and safety during the rehabilitation process, the kinematic model of coronal-axis-rotation part, vertical-axis-rotation part and rehabilitation bed are established. Using MATLAB, the model and numerical simulation were carried out to obtain the curve of joint change when the waist rehabilitation bed was used for different functions, which verifies the effectiveness of the mechanism.

Diez años de experiencia con el tratamiento multimodal de la fase aguda de la enfermedad de Peyronie: reporte médico de la vida real

ObjectivesTo present our experience with multimodal therapy for Peyronie's disease. MethodsRetrospective data were collected since 2008 to 2017. The following features were evaluated at baseline and after treatment: age, duration of disease, erectile function, erected penile curvature, and stretched penile length. All patients were offered the same protocol including: 12 intralesional verapamil injections, oral therapy (OT) ?L-arginine 2g once and pentoxifylline 400mg 3 times a day for 6 months?, and penile traction therapy. The adherence to each of the 3 components of multimodal treatment was evaluated. ResultsOne hundred and seventy-seven individuals were considered. Depending on the grade of adherence our survey was divided into 3 groups. Group 1: patients who only completed OT; group 2: men who accomplished OT and intralesional verapamil injections; group 3: patients who completed the entire protocol. Seventy-six, 45 and 56 men were assigned to group 1, 2 and 3 respectively. The mean age at the diagnosis was 59±8.4, 59.1±5.9 and 54.2±4.8 years, while the mean duration of the disease was 6.3±3.4, 4.8±2.9 and 3.9±3.1 months in group 1, 2 and 3. The erected penile curvature before and after treatment was 24.2±9 and 23.7±8.9° in group 1 (P<.36); 25.4±16.8 and 24.1±13.6° in group 2 (P<.34), and 34.3±17.9 and 26.1±17.2° in group 3 (P<.001). ConclusionsOT alone was successful to block the progression of the disease. The add of intralesional verapamil injections to OT brought only mild improvements. The complete protocol significantly reduced erected penile curvature and improved erectile function.

Penile Stretching as a Treatment for Peyronie's Disease: A Review.

Peyronie's disease (PD) is a debilitating condition that affects a sizable number of men worldwide. Current treatment options consist of oral therapy, intralesional injections, and surgery. Penile stretching has been used as a treatment for PD, including penile traction therapy (PTT) and vacuum erection devices (VEDs), with numerous trials completed or underway. To present and summarize the current literature on penile stretching for the treatment of PD. Using PubMed, we performed a literature review of studies from January 1990 through July 2018 that focused on penile stretching for PD management. PTT and VED were included in the search criteria. Penile curvature correction was effective, and stretched penile length was improved. PD therapies that use penile stretching as a mechanical intervention to alter tissue characteristics were studied. PTT has been successful in primary penile lengthening and curvature correction in the acute phase of PD. PTT also improved length retention in men undergoing plication and incision/grafting procedures. Combination of PTT and intralesional injection therapy for PD treatment requires further investigation. There are fewer studies investigating VEDs and their role in PD management, but initial small trials suggest a role in curvature correction and penile lengthening. Penile stretching is an effective therapy for PD. Data from limited trials suggest a role for PTT and VEDs in the management of PD, although further research is needed. Cowper MG, Burkett CB, Le TV etal. Penile Stretching as a Treatment for Peyronie's Disease: A Review. Sex Med Rev 2019;7:508-515.

The use of penile traction therapy in the management of Peyronie's disease: current evidence and future prospects.

Peyronie’s disease is a disorder of abnormal and dysregulated wound healing leading to scar formation in the tunica albuginea of the penis. Penile traction therapy has emerged as an attractive therapeutic option for men with Peyronie’s disease in both the acute and chronic phases. Currently, clinical studies are limited by lack of randomization, small cohorts, and lack of patient compliance with therapy. Despite these shortcomings, studies have shown a potential benefit with minimal morbidity. Specifically, penile traction may help to preserve or increase penile length and reduce penile curvature when used as monotherapy or as adjuvant therapy for surgical and intralesional treatments. Further study is necessary to define patient characteristics that are predictive of improved outcomes, determine the duration of treatment needed for clinical effect, and improve patient compliance.

Review of Management Options for Active-Phase Peyronie's Disease.

Peyronie's disease (PD) is a fibrotic disorder that leads to plaque formation in ∼3-9% of adult men. Connective tissue buildup results in plaque formation, penile curvature and shortening, and in some cases, pain. In the active phase of PD, penile pain is a common symptom, often accompanied by progression in curvature. Treatment options for PD include oral drugs, topical cream, intralesional injections, traction, and shock wave therapy. This article reviews the different treatment options for active-phase PD. To provide a comprehensive review of the current evidence-based treatments, focusing on active-phase PD. A PubMed database search was performed for studies on conservative therapy. We reviewed current clinical practices and trials for the treatment of active-phase PD and assessed their applicability as treatment options. Define the most recent and effective therapies for the improvement in penile curvature in men presenting with acute PD. A number of trials have resulted in significant benefits in the treatment of PD. Many of the oral therapies studied improved patient outcomes, but the data are insufficient. Similarly, there is no approved topical therapy by guidelines. The best options are intralesional injections of collagenase Clostridium histolyticum (CCh) and interferon-α2b. Shock wave therapy is not recommended for treatment of curvature, but has been shown to improve pain. Traction therapy may have a role in improving PD curve and penile length. PD remains a challenge for urologists. Evidence suggests that, for oral therapy, a combination of drugs produces better results. Shock wave therapy is still unproven. Intralesional therapy delivers the best evidence for improvement in the active phase. CCh is the only FDA-approved treatment option available. Peniletraction therapy may improve patient outcomes. Brimley SC, Yafi FA, Greenberg J, etal. Review of Management Options for Active-Phase Peyronie's Disease. Sex Med Rev 2019;7:329-337.

Penile traction therapy with the new device 'Penimaster PRO' is effective and safe in the stable phase of Peyronie's disease: a controlled multicentre study.

To evaluate the efficacy and safety of a new penile traction device (PTD), 'Penimaster PRO', in a group of patients with stable Peyronie's disease (PD) compared with a non-intervention group in a multicentre study. A total of 93 patients with chronic stable PD (without erectile dysfunction, with no significant pain, and with a unidirectional curvature of at least 45° being stable for > 3months) were recruited and followed for a 12-week period. Of these patients, 47 were randomly assigned to the Penimaster PRO group (PG) and 46 to the non-intervention group (NIG). Patients were asked to apply the PTD 3-8h a day for 12 consecutive weeks, with specific instructions regarding the progressive increase of traction force applied to the penis over time. The primary outcome of the study was the change in the degree of curvature measured in the fully erect state after intracavernosal injection of alprostadil at baseline, 1, 2 and 3months. Other variables, such as the type of curvature, stretched penile length (SPL), Peyronie's Disease Questionnaire (PDQ) scores, erectile function domain of the International Index of Erectile function (IIEF-EF) score and adverse events (AEs) were also assessed in each visit. Forty-one patients in the PG and 39 in the NIG completed the study. There was an overall reduction in curvature of 31.2° (P < 0.001) at 12weeks compared to baseline in the PG, representing a 41.1% improvement from baseline, which significantly correlated with the number of daily hours the device was applied in a dose-dependent manner. Those patients using the device < 4h/day experienced a reduction of 15°-25° (mean 19.7°, 28.8% improvement; P < 0.05), while patients using the device > 6h/day experienced greater curvature reduction, ranging from 20° to 50° (mean of 38.4°, 51.4% improvement; P < 0.001). In contrast, no significant changes in curvature were observed in the NIG. Furthermore, SPL increased significantly in the PG compared to baseline and compared with the NIG, ranging from 0.5 to 3.0cm (mean 1.8cm; P < 0.05). The IIEF-EF score also improved in patients in the PG (by a mean of 5 points). Mild AEs occurred in 43% of patients, such as local discomfort and glans numbness. The use of the Penimaster PRO PTD, a non-invasive treatment, should be offered to patients with stable PD for 3 consecutive months before performing any corrective surgery, as this provided a significant reduction in the curvature, an increase in penile length and a significant improvement of the symptoms and bother induced by PD.

Penile traction therapy — efficacy in PD

Penile traction therapy — efficacy in PD