N48.6
Conditions
Interventions
Group 1: Penile traction using a traction device for 30–60 minutes per day over a period of three months, followed by use at the patient’s discretion for an additional three months and three months wi
Sponsors
Universität Münster
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Ability to understand and willingness to sign a written informed consent form - Diagnosis: Induratio penis plastica (N48.6) - Curvature of =30 degrees in a single plane - Chronic induratio penis plastica (stable condition for = 12 weeks) that causes significant distress to the patient
Exclusion criteria
Exclusion criteria: - Prior treatment with a traction device Note: Previous use of a vacuum erection device does not constitute a contraindication. - History of surgical treatment for IPP - History of surgery on the penis or scrotum within the last 6 weeks - Chronic pain in the penis, testicles, or scrotum that is not related to IPP - Skin infections and chronic open wounds on the penis or scrotum - Congenital absence and aplasia of the penis (Q55.5) - Other specified congenital malformations of the male genital organs such as congenital penile deviation (Q55.8) - Previous surgical treatment of hypospadias - Stretched penile length <7 cm - Erectile dysfunction that does not respond to phosphodiesterase-5 inhibitors or intracavernosal injection therapies - Severe vascular diseases, including loss of sensation in fingers, toes, or limbs due to ischemia - Diabetes mellitus with signs of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher) - Any psychological, familial, sociological, or geographical situation that could impair adherence to the study protocol and follow-up plan - Participation in interventional clinical trials (concurrently or within the last 30 days) - Private health insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary, hierarchically ordered endpoints: 1)Proportion of patients with a reduction of at least 20% in the leading penile deviation during erection 9 months after randomization compared to baseline 2) Change in symptom burden 9 months after randomization, defined as the change in the Symptom Bother domain of the Peyronie’s Disease Questionnaire (PDQ) compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in the curvature of the dominant penile deviation at baseline (as a continuous outcome measure) • Change in the sum of penile deviations (as a continuous outcome measure) • Change in penile length (as a continuous outcome measure) • Proportion of patients with a reduction in the primary penile deviation at baseline of at least 20% at 3 and 6 months after randomization • Proportion of patients with a reduction in the sum of penile deviations of at least 20% at 3, 6, and 9 months after randomization • Health-related quality of life (Quality of Life measure for men with erection difficulties, QoL-Med) • Pain (PDQ, Penile Pain domain) • Psychological symptoms (PDQ, Psychological and Physical Symptoms domain) • Sexual function (International Index of Erectile Function, IIEF) • (Serious) adverse events (AE) • Dropout rate | — |
Countries
Germany
Contacts
Public ContactLaura Spital
Studiensekretariat der Klinik für Andrologie, Centrum für Reproduktionsmedizin und Andrologie, UK Münster
Outcome results
None listed