Peyronie’s Disease. Induration penis plastica
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: A definitive diagnosis of Peyronie's disease must be made and at least 6 months have passed since the onset of symptoms The patient's age is between 40 and 70 years. The plaque condition is in the acute phase. The patient must have written consent to participate in the study.
Exclusion criteria
Exclusion criteria: Having active cardiovascular disease Presence of a pacemaker Have severe autoimmune diseases. Have a history of surgery in the penis area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of pain reduction in patients during erection using the Visual Analog Scale. Timepoint: Patient assessments are conducted at five time points: at the beginning of the study, one month after the end of treatment, three months after treatment, six months, and twelve months after treatment. Validated questionnaires are used to assess the effects of treatment. Method of measurement: It is a simple and valid tool for measuring pain intensity. The scale is designed as a 10 cm straight line, with one end indicating "no pain" and the other end indicating "the most pain possible." - Collection method: Patients are asked to indicate their pain intensity by marking this line at each treatment session and at designated follow-up times. The score is calculated from 0 to 10 and is used for data analysis.;Evaluation of erectile function and related disorders. Timepoint: Patient assessments are conducted at five time points: at the beginning of the study, one month after the end of treatment, three months after treatment, six months, and twelve months after treatment. Validated questionnaires are used to assess the effects of treatment. Method of measurement: Patients are given the International Index of Erectile Function questionnaire. Scores range from 5 to 25, with higher scores indicating better sexual function.;Volume of fibrotic plaques. Timepoint: Patient assessments are conducted at five time points: at the beginning of the study, one month after the end of treatment, three months after treatment, six months, and twelve months after treatment. Validated questionnaires are used to assess the effects of treatment. Method of measurement: It is measured using a clinical examination before the procedure and at each follow-up stage. The results obtained before and after treatment are compared for each patient and appropriate statistical methods are used to analyze the changes.;Concerns about the appearance of the penis, and problems with sexual intercourse. Timepoin | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life assessment. Timepoint: Patient assessments are conducted at five time points: at the beginning of the study, one month after the end of treatment, three months after treatment, six months, and twelve months after treatment. Validated questionnaires are used to assess the effects of treatment. Method of measurement: The Short Form Health Survey questionnaire is given to patients. It consists of 36 questions in eight different dimensions of physical functioning, social functioning, mental health, and general health. The score for each dimension ranges from 0 to 100, with higher scores indicating higher quality of life. | — |
Countries
Iran (Islamic Republic of)
Contacts
Tehran University of Medical Sciences