N48.6
Conditions
Interventions
Group 1: The study cohort comprises 25 adult men with Peyronie's disease (IPP) and a penile deviation >30° who are scheduled for surgical correction using a rectus abdominis fascia autograft. The stud
the estimated survey duration is about 15-20 minutes per visit.
Sponsors
Universitätsklinikum Bonn, Klinik und Poliklinik für Urologie und Kinderurologie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of induratio penis plastica with significant penile deviation (> 30°), documented with photographs in two planes Surgical correction of IPP using autografts of the fascia of the rectus abdominis muscle, already indicated regardless of study participation Stable penile plaques (no progression for at least 3 months). Willingness and ability to attend all study visits and complete the questionnaires. Signing of the written informed consent form
Exclusion criteria
Exclusion criteria: Inability to understand the implications of participation Lack of capacity to give informed consent Desire to preserve the prepuce Active penile inflammation or infection. Recent penile surgery (< 6 months). Presence of untreated severe erectile dysfunction that is not primarily caused by the deviation. Cancer or other serious systemic diseases that could affect the prognosis or participation in the study. Participation in another interventional study. Cognitive impairments that prevent the participant from understanding or completing questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Peyronie’s disease questionnaire 3 and 6 months following surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in IIEF-5 (International Index of Erectile Function) 3 and 6 months following surgery Changes in AMS (Aging Male Symptoms) 3 and 6 months following surgery Changes in EQ-5D-5L (Quality of Life) 3 and 6 months following surgery Objective measurement of curvature (in degrees) during an induced erection 90 days postoperatively Incidence and severity of complications (Clavien-Dindo classification) during the course of the study. Recurrence rate of penile curvature or need for re-intervention during the course of the study. | — |
Countries
Germany
Contacts
Public ContactThomas Büttner
Universitätsklinikum Bonn, Klinik und Poliklinik für Urologie und Kinderurologie
Outcome results
None listed