Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy- randomized, placebo-controlled, double-blind clinical trial. - 2015-Adf

Odense Universitets Hospital0 个研究点目标入组 36 人开始时间: 2016年1月20日最近更新: 2021年5月17日

适应症

试验速览

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•prostatectomy men, no matter what surgical technique that has been used.
•Age of 18
•Organic erectile dysfunction (ED), lasting at least 6 months.
•patients with a preoperative IIEF-5 score greater than 22, and a 5-IIEF score between 5 and 20 (with or without drug potency) / EHS 1 or greater
•Involved in a monogamous, heterosexual relationship (when the questionnaires are validated for these) at least 3 months in which both parties are motivated to have or attempt intercourse
•Not interested or not able to use standard medical treatment for erectile dysfunction
•Do not have sufficient power of standard medical treatment for erectile dysfunction
•Subcutaneous fat suitable for liposuction at least 120ml
•Interested to forgo participation in any other study throughout the study, unless prior approval from the sponsor
•Skills in Danish reading and writing, so that they can answer the questionnaires.
•The ability to give informed consent.
•perfomance status 0
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•Men who have had problems with before (general discomfort, intolerance for anesthetizing substances, venous blood clots after prostatectomy) anesthesia during the removal of the prostate.
•Significant incontinence after prostatectomy. Defined as more than two volumes DGL.
•Men where pathology study suspect of not free resektionsrande.
•Men who are in preventive anticoagulant treatment and does not tolerate interruption or replacement therapy fragmin / heparin.
•Men indicating not having pleasure in sexual intercourse with a partner or themselves.
•Previous pelvic radiation or surgery beyond prostatectomy.
•systemic autoimmune disorder
•Alcohol abuse or other substance abuse.

发起方

Odense Universitets Hospital