Идёт набор NCT07117955

Platelet-Rich Plasma for Peyronie's Disease

Без фазы С лечением Peyronies Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Autologous Platelet Rich Plasma, Saline solution.
Кому может быть актуально: Состояния в реестре: Peyronies Disease. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Treatment of Peyronie's Disease With Platelet-Rich Plasma: A Randomized, Double-blind, Placebo-controlled Clinical Trial

Обзор

The purpose of this clinical trial is to evaluate the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase.

Подробное описание

The study protocol is structured such that participants, after being informed about the project and providing consent, will attend a baseline visit where relevant data will be collected from the participant, questionnaires, the patient's medical record, and through an objective examination. A total of 84 patients with Peyronie's disease will be included. Participants will be stratified based on the degree of penile curvature at baseline (30-60 degrees or \>60 degrees) and randomized in a 1:1 ratio to receive either active treatment with Platelet-Rich Plasma (PRP) or placebo (saline). Subsequently, participants will attend weekly injection sessions for 3 weeks consisting of either PRP or saline in a randomized, double-blind manner. A follow-up visit will take place three months after the final injection for outcome assessment. Two additional long-term follow-up visits will be conducted at 6 and 12 months post-treatment. Analysis will then be conducted.

Вмешательства

Другое Autologous Platelet Rich Plasma
6 mL PRP intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.
Другое Saline solution
6 mL saline solution intralesional injections will be administered. After the injections, participants will be instructed to perform penile stretching exercises daily until the next injection and to continue these exercises after the final injection until the 3-month follow-up.

Первичные конечные точки

Degree Changes in Penile Curvature. [Срок оценки: From enrollment to 12 months post intervention.]

Вторичные конечные точки (7)

Changes in Plaque Size [Срок оценки: From enrollment to 12 months post intervention.]
Changes in the Peyronie's Disease Questionnaire (PDQ) [Срок оценки: From enrollment to 3 months post intervention.]
Changes in the Erection Hardness Score (EHS) [Срок оценки: From enrollment to 12 months post intervention.]
Changes in the Major Depression Inventory (MDI) [Срок оценки: From enrollment to 12 months post intervention.]
The Ability to Engage in Sexual Intercourse (question) [Срок оценки: From enrollment to 12 months post intervention.]
Preference for Surgical Intervention (question) [Срок оценки: From enrollment to 12 months post intervention.]
Changes in Global Assessment Scale Questionnaire [Срок оценки: From 3 to 12 months post intervention.]

Критерии участия

Критерии включения

18 years or older
Be able to provide written informed consent
Diagnosis of PD without active pain and without progressive curvature over the past 3 months (fibrotic phase).
Penile curvature of 30-95 degrees
Clearly palpable penile plaque