The Federal Joint Committee (G-BA) has tasked the Institute for Quality and Efficiency in Health Care (IQWiG) with investigating the effectiveness of traction therapy in treating induratio penis plastica (IPP) – a condition characterized by penile curvature, pain, and impaired sexual function. However, existing data on traction therapy is limited, with only two randomized controlled studies (RCTs) providing short-term evidence spanning three months. As a result, it remains unclear whether traction therapy offers lasting benefits for IPP patients.
Despite the limited data, the initial study results suggest that traction therapy holds potential as an alternative treatment for IPP. IQWiG has thus outlined key points for a comprehensive test study that would shed light on the long-term advantages and disadvantages of traction therapy compared to no treatment.
One of the existing studies shows that traction therapy can reduce penile curvature over three months. However, its long-term efficacy is uncertain, and data on other factors such as pain, sexual function, symptom burden, and side effects are lacking. Moreover, psychological impact and health-related quality of life have not been adequately assessed.
It is essential to recognize that IPP severity varies widely among individuals, with diverse experiences and needs. A test study should focus on patient-relevant factors, considering how the disease affects patients’ lives, what treatment goals they aim to achieve, and their prior therapy experiences.
To address these gaps, a two-arm, multicenter RCT with a minimum one-year follow-up period is proposed. This study would evaluate the positive and negative effects of traction therapy compared to no treatment, incorporating patient-relevant outcomes like sexual function, pain, symptom burden, quality of life, and treatment side effects.
IPP varies between acute and stable phases, and as such, the study should include participants from both phases to comprehensively assess traction therapy’s effects on the entire patient population. The mechanism of action of different traction devices is similar, allowing for the inclusion of various approved devices available in the European market.
Ultimately, a robust study will provide crucial insights into the potential benefits and limitations of traction therapy for IPP patients. The G-BA will define the study’s key points and commission an independent scientific institution to carry out the research if it decides to proceed based on IQWiG’s assessment.
This study aims to address critical gaps in understanding the long-term efficacy and impact of traction therapy on IPP patients’ lives, potentially offering valuable treatment alternatives for a condition with limited conservative therapy options in Germany.
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