Review question
In men with Peyronie's disease, how do treatments that are not surgery, such as pills, creams, injections, or treatments using shock waves, affect men's reported sexual function?
Background
Peyronie's disease may cause penile curvature, pain, or both, which makes it difficult to perform penetrative intercourse. Aside from surgery, many other treatments may or may not help with this disease, but it is unclear how well they work.
Methods
We used the recommended Cochrane methods, including GRADE to rate the certainty of the evidence.
Search date
The findings of our review are up-to-date to 23 September 2022.
Study characteristics
We included 14 trials in 1810 men with Peyronie's disease. We only included studies that compared these treatments to placebo (a similar-looking pill or injection with no active drug), sham (pretend) treatment, or no treatment. We only included studies in which chance decided what treatment the men got.
Key results
We found evidence for 10 different types of treatment that did not involve a surgical procedure. Here in this summary, we focus on the ones that experts told us were the most important to know about. Also, here we only report on the three main outcomes: patients' self-reported ability to have intercourse, their quality of life, and side effects. We also summarize data on the degree of penile curvature.
Injectional collagenase (short-term): We found no evidence about how injectional collagenase affects patients' self-reported ability to have intercourse or causes treatment-related unwanted side effects in the short term. Injectional collagenase may result in little to no difference in quality of life. There may be little to no effect on the degree of penile curvature.
Injectional collagenase (long-term): We also found no evidence about how injectional collagenase affects patients' self-reported ability to have intercourse in the long term. Injectional collagenase likely results in little to no difference in quality of life, but likely increases unwanted side effects. Also, in the long term, it may result in little to no change in the degree of penile curvature.
Injectional verapamil (short-term): We are very uncertain how injectional verapamil may affect patients' self-reported ability to have intercourse. We found no evidence for the outcome of quality of life. We are very uncertain how injectional verapamil may affect treatment-related side effects. Similarly, we are very uncertain how injectional verapamil may affect the degree of penile curvature.
We found no long-term data for any outcome.
Extracorporeal shock wave treatment (ESWT): We are very uncertain how ESWT affects patients' self-reported ability to have intercourse. ESWT may result in little to no difference in quality of life. We are again very uncertain if ESWT has an effect on treatment-related side effects. ESWT may result in little to no difference in the degree of penile curvature compared to placebo.
We found no long-term data for any outcome.
Penile traction therapy (short-term): We found no evidence about whether penile traction therapy compared to no treatment affects patients' self-reported ability to have intercourse. We are very uncertain how traction therapy may affect quality of life. We are also very uncertain how traction therapy may affect treatment-related side effects and how it affects the degree of curvature.
We found no long-term data for any outcome.
Certainty of the evidence
The certainty of the evidence is mainly very low or low for most of the interventions assessed. The certainty of the evidence is moderate for injectional collagenase (long-term outcomes). This means that our confidence in the results ranges from very low to moderate (and is mostly very low).
There is little evidence supporting the effectiveness of most non-surgical treatments for Peyronie’s disease. Existing trials are mostly of poor methodological quality and/or fail to address patient-centered outcomes. Injectional collagenase appears to have some effectiveness; however, many individuals may not experience the improvement as clinically relevant, and this comes with the risk of increased adverse events. There is a critical need for better non-surgical treatment options for men with Peyronie’s disease.
Peyronie's disease is a condition that results in the development of penile plaques that can lead to penile curvature, pain, and erectile dysfunction, making sexual activity difficult. A number of non-surgical interventions exist to improve this condition, which include topical and injection agents as well as mechanical methods; however, their effectiveness remains uncertain. We performed this review to determine the effects of these non-surgical treatments.
To assess the effects of non-surgical therapies compared to placebo or no treatment in individuals with Peyronie's disease.
We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings, up to 23 September 2022. We applied no restrictions on publication language or status.
We included trials in which men with Peyronie's disease were randomized to undergo non-surgical therapies versus placebo or no treatment for penile curvature and sexual function.
Two of four review authors, working in pairs, independently classified studies and abstracted data from the included studies. Primary outcomes were: patient-reported ability to have intercourse, quality of life, and treatment-related adverse effects. Secondary outcomes were: degree of penile curvature, discontinuation from treatment (for any reason), subjective patient-reported change in penile curvature, and improvement in penile pain. We performed statistical analyses using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach.
Our search identified 1288 relevant references of which we included 18 records corresponding to 14 unique randomized controlled trials (RCTs) with 1810 men. These informed 10 distinct comparisons with relevant outcome data that were mostly extracted from single trials. In this abstract, we focus only on the most clinically relevant comparisons for the three primary outcomes and also include the outcome of degree penile curvature.
Injectional collagenase (short-term): We found no short-term evidence on injectional collagenase for patients' self-reported ability to have intercourse and treatment-related adverse effects compared to placebo injection. Injectional collagenase may result in little to no difference in quality of life (scale 0 to 20 with lower scores indicating better quality of life; mean difference (MD) 1.8 lower, 95% confidence interval (CI) -3.58 to -0.02; 1 study, 134 participants; low CoE) and there may be little to no effect on the degree of penile curvature (MD 10.90 degrees less, 95% CI -16.24 to -5.56; 1 study, 136 participants; low CoE).
Injectional collagenase (long-term): We also found no long-term evidence on injectional collagenase for patients' self-reported ability to have intercourse compared to placebo injection. It likely results in little to no effect on quality of life (MD 1.00 lower, 95% CI -1.60 to -0.40; 1 study, 612 participants; moderate CoE). Treatment-related adverse effects are likely increased (risk ratio (RR) 2.32, 95% CI 1.98 to 2.72; 1 study, 832 participants; moderate CoE). Injectional collagenase likely results in little to no change in the degree of penile curvature (MD 6.90 degrees less, 95% CI -9.64 to -4.14; 1 study, 612 participants; moderate CoE).
Injectional verapamil (short-term): We are very uncertain how injectional verapamil may affect patients' self-reported ability to have intercourse compared to placebo injection short-term (RR 7.00, 95% CI 0.43 to 114.70; 1 study, 14 participants; very low CoE). We found no evidence for the outcome of quality of life. We are very uncertain how injectional verapamil may affect treatment-related adverse effects (RR not estimable; 1 study, 14 participants; very low CoE). Similarly, we are very uncertain how injectional verapamil may affect degree of penile curvature (MD -1.86, 95% CI -10.39 to 6.67; 1 study, 14 participants; very low CoE). We found no long-term data for any outcome.
Extracorporeal shock wave treatment (ESWT) (short-term): We are very uncertain how ESWT affects patients' self-reported ability to have intercourse short-term (RR 1.60, 95% CI 0.71 to 3.60; 1 study, 26 participants; very low CoE). ESWT may result in little to no difference in quality of life (MD 3.10, 95% CI 1.57 to 4.64; 2 studies, 130 participants; low CoE). We are very uncertain if ESWT has an effect on treatment-related adverse effects (RR 2.73, 95% CI 0.74 to 10.14; 3 studies, 166 participants; very low CoE). ESWT may result in little to no difference in the degree of penile curvature compared to placebo (RR -2.84, 95% -7.35 to 1.67; 3 studies, 166 participants; low CoE). We found no long-term data for any outcome.
Penile traction therapy (short-term): We found no evidence for whether penile traction compared to no treatment affects patients' self-reported ability to have intercourse. We are very uncertain how traction therapy may affect quality of life (MD 1.50 lower, 95% CI -3.42 to 0.42; 1 study, 90 participants; very low CoE). We are also very uncertain how traction therapy may affect treatment-related adverse effects (RR not estimable; 1 study, 90 participants; very low CoE) and how it affects the degree of curvature (MD 7.40 degrees less, 95% CI -11.18 to -3.62; 1 study, 89 participants; very low CoE). We found no long-term data for any outcome.