madman
Super Moderator
ABSTRACT
Introduction: Penile traction therapy (PTT) aims to non-surgically reduce curvature, enhance girth, and recover lost length. Available clinical practice guidelines however lack clear recommendations regarding their use.
Aim: To present a comprehensive review and recommendation regarding the available evidence to the use of PTT in Peyronie’s disease (PD).
Methods: A systematic literature search was performed on Pubmed and Medline for relevant studies from all times until 2019. Studies of PTT (monotherapy and in combination) in patients with PD with any documented degree of curvature and in either the acute or chronic phase of the disease were included. Full texts not published in the English language were excluded.
Main outcomes measures: Several scenarios, including preclinical data, have been investigated. For each topic covered evidence was analyzed and expert opinion was stated.
Results: The paucity of high-level studies precluded any strong recommendations, however, specific statements on this topic, summarizing the ESSM position, were provided. The available data about the use of PTT in PD are still poor, and the impact of this therapy on the treatment of PD has not been clearly established. Available data in the clinical setting are still poor, and the impact of these devices on PD evolution has not been clearly established.
Conclusion: PTT seems to be a valid treatment option for PD, although there is not enough evidence to give any definitive recommendation in any clinical scenario.
INTRODUCTION
Penile traction therapy (PTT) represents an emergent therapeutic option for men with Peyronie’s disease (PD).1 The accessibility for clinicians and patients in terms of acquisition and ease of use has increased their popularity in recent years.
There are several penile traction devices easily available in the market with a similar design, although most of them are not supported by any scientific background. The effect of very few has been specifically studied in the literature, as for instance FastSize Medical Extender (FastSize, Aliso Viejo, CA, USA)2 , the PeniMaster Pro (MSC Concept, Berlin, Germany)3 , or the RestoreX (PathRight Medical Inc, Plymouth, USA).4 The common stated clinical goals of all PTT are to non-surgically reduce curvature, enhance girth, and recover lost length, all of which are recognized concerns in patients suffering from PD.5 The American Urological Association Guideline on PD does not provide any recommendation related to PTT, acknowledging that the study samples were too small.6 The Evidence-Based Management Guidelines on PD, supported by the International Consultation on Sexual Medicine, however, stated that PTT may have some benefits in PD.7 Accordingly, the Guidelines on Sexual and Reproductive Health by the European Association of Urology state that PTT seems to be effective and safe for patients with PD, but there is still a lack of evidence to give any definitive recommendation in terms of monotherapy for PD.8
A recent review by Avant et al9 concluded that PTT has a potential role as a primary lengthening therapy (modest improvements); in curvature correction prior to penile prosthesis insertion; and after surgical correction of PD as part of post-operative rehabilitation. Whereas pre-operative and postoperative PTT can result in length preservation after surgery for PD10,11, the role of PTT in combination therapy with Clostridium Histolyticum (CCH) injections are still unclear.12
The aim of the present paper is to provide a detailed position statement of the European Society for Sexual Medicine (ESSM) on this topic, summarizing and emphasizing the current available evidence, any possible conflicting issues, and the need for further clarifications.
PRECLINICAL DATA
Statement 1. Although mechanical traction can modify connective tissue, more studies are needed to improve our understanding of the pathways involved in the PTT effect on PD.
*Evidence
*Expert Opinion
CLINICAL EVIDENCE
PTT AS PRIMARY TREATMENT FOR PD
Statement 2. PTT shows promising results for patients with PD. Further stratification in terms of patient and disease characteristics is still required in order to identify those subjects most likely to benefit from PTT. The limited evidence prevents any definitive recommendation.
*Evidence
*Expert Opinion
PTT PRIOR TO PD SURGERY
Statement 3. Available data do not support the use of PPT for PD before surgery.
*Evidence
*Expert Opinion
PTT AFTER PD SURGERY
Statement 4. Although promising results from preliminary studies, available data do not support the use of PTT after PD surgery.
*Evidence
*Expert Opinion
PTT IN COMBINATION WITH ORAL OR INTRALESIONAL TREATMENTS
Statement 5. There is not enough data to recommend the use of PTT as a concomitant treatment with oral or intralesional therapy.
*Evidence
*Expert Opinion
PTT SAFETY
Statement 6. PTT adverse effects are mild and well-tolerated.
*Evidence
*Expert Opinion
CONCLUSIONS
Data about the use of PTT in patients with PD is still limited. There are many aspects that require clarification through well-designed trials before evidence-based recommendations can be made. The ideal PD patient for PTT is still undefined and requires investigation. Moreover, the role of adjuvant PTT also requires further well-designed trials before strong recommendations can be made for its use
In summary, preliminary data suggest that PTT may be a promising treatment option for PD, although there is not enough evidence to give any definitive recommendation in any clinical scenario. Large well-designed and adequately powered RCTs are required to better clarify all these aspects.
Introduction: Penile traction therapy (PTT) aims to non-surgically reduce curvature, enhance girth, and recover lost length. Available clinical practice guidelines however lack clear recommendations regarding their use.
Aim: To present a comprehensive review and recommendation regarding the available evidence to the use of PTT in Peyronie’s disease (PD).
Methods: A systematic literature search was performed on Pubmed and Medline for relevant studies from all times until 2019. Studies of PTT (monotherapy and in combination) in patients with PD with any documented degree of curvature and in either the acute or chronic phase of the disease were included. Full texts not published in the English language were excluded.
Main outcomes measures: Several scenarios, including preclinical data, have been investigated. For each topic covered evidence was analyzed and expert opinion was stated.
Results: The paucity of high-level studies precluded any strong recommendations, however, specific statements on this topic, summarizing the ESSM position, were provided. The available data about the use of PTT in PD are still poor, and the impact of this therapy on the treatment of PD has not been clearly established. Available data in the clinical setting are still poor, and the impact of these devices on PD evolution has not been clearly established.
Conclusion: PTT seems to be a valid treatment option for PD, although there is not enough evidence to give any definitive recommendation in any clinical scenario.
INTRODUCTION
Penile traction therapy (PTT) represents an emergent therapeutic option for men with Peyronie’s disease (PD).1 The accessibility for clinicians and patients in terms of acquisition and ease of use has increased their popularity in recent years.
There are several penile traction devices easily available in the market with a similar design, although most of them are not supported by any scientific background. The effect of very few has been specifically studied in the literature, as for instance FastSize Medical Extender (FastSize, Aliso Viejo, CA, USA)2 , the PeniMaster Pro (MSC Concept, Berlin, Germany)3 , or the RestoreX (PathRight Medical Inc, Plymouth, USA).4 The common stated clinical goals of all PTT are to non-surgically reduce curvature, enhance girth, and recover lost length, all of which are recognized concerns in patients suffering from PD.5 The American Urological Association Guideline on PD does not provide any recommendation related to PTT, acknowledging that the study samples were too small.6 The Evidence-Based Management Guidelines on PD, supported by the International Consultation on Sexual Medicine, however, stated that PTT may have some benefits in PD.7 Accordingly, the Guidelines on Sexual and Reproductive Health by the European Association of Urology state that PTT seems to be effective and safe for patients with PD, but there is still a lack of evidence to give any definitive recommendation in terms of monotherapy for PD.8
A recent review by Avant et al9 concluded that PTT has a potential role as a primary lengthening therapy (modest improvements); in curvature correction prior to penile prosthesis insertion; and after surgical correction of PD as part of post-operative rehabilitation. Whereas pre-operative and postoperative PTT can result in length preservation after surgery for PD10,11, the role of PTT in combination therapy with Clostridium Histolyticum (CCH) injections are still unclear.12
The aim of the present paper is to provide a detailed position statement of the European Society for Sexual Medicine (ESSM) on this topic, summarizing and emphasizing the current available evidence, any possible conflicting issues, and the need for further clarifications.
PRECLINICAL DATA
Statement 1. Although mechanical traction can modify connective tissue, more studies are needed to improve our understanding of the pathways involved in the PTT effect on PD.
*Evidence
*Expert Opinion
CLINICAL EVIDENCE
PTT AS PRIMARY TREATMENT FOR PD
Statement 2. PTT shows promising results for patients with PD. Further stratification in terms of patient and disease characteristics is still required in order to identify those subjects most likely to benefit from PTT. The limited evidence prevents any definitive recommendation.
*Evidence
*Expert Opinion
PTT PRIOR TO PD SURGERY
Statement 3. Available data do not support the use of PPT for PD before surgery.
*Evidence
*Expert Opinion
PTT AFTER PD SURGERY
Statement 4. Although promising results from preliminary studies, available data do not support the use of PTT after PD surgery.
*Evidence
*Expert Opinion
PTT IN COMBINATION WITH ORAL OR INTRALESIONAL TREATMENTS
Statement 5. There is not enough data to recommend the use of PTT as a concomitant treatment with oral or intralesional therapy.
*Evidence
*Expert Opinion
PTT SAFETY
Statement 6. PTT adverse effects are mild and well-tolerated.
*Evidence
*Expert Opinion
CONCLUSIONS
Data about the use of PTT in patients with PD is still limited. There are many aspects that require clarification through well-designed trials before evidence-based recommendations can be made. The ideal PD patient for PTT is still undefined and requires investigation. Moreover, the role of adjuvant PTT also requires further well-designed trials before strong recommendations can be made for its use
In summary, preliminary data suggest that PTT may be a promising treatment option for PD, although there is not enough evidence to give any definitive recommendation in any clinical scenario. Large well-designed and adequately powered RCTs are required to better clarify all these aspects.
