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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
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The goal of this study was to investigate if adipose derived regenerative cells can be used as a treatment for erectile dysfunction following radical prostatectomy.
70 participants were enrolled in the study and was performed as a double- blinded study. 35 participants in the active study arm recieved an injection into the penis of adipose derived regenerative cells, while the participants of the placebo arm recieved a placebo injection.
All 70 participants undervent liposuccion of the abdomen to harvest the adipose derived regenerative cells, and the 35 participants in the active study arm recieved their own regenerative cells.
All participants answered the questionnaires International-Index-of- Erectile function 5 and Erection Hardness Scale before treatment and after 1,3,6 and 12 months. These data was used to evaluate the effect of one injection of adipose derived regenerative cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | One injection of Ringer Lactate |
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| Active treatment | Experimental | Injection of adipose derived regnerative cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose-Derived Regenerative Cells | Drug | Adipose-derived regenerative cells was injected into the corpus cavernosum. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in International-Index-of-Erectile-Function 5 12 months after intervention | All paticipants answered the questionnaire International-Index-of-Erectile-Function 5 at baseline and after 12 months. The questionnaire focus on confidence, erection hardness, maintaining erection and satisfaction during intercourse. The scale of the score is from 5 to 25. The higher the score is, the better is the erectile function. A score from 5-7 means severe erectile dysfunction A score from 8-11 is moderate erectile dysfunction A score from 12-16 is mild to moderate erectile dysfunction A score from 17-21 is mild erectile dysfunction A score from respresents no erectile dysfunction. A higher score after 12 months means that the erectile function is improved. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Erectile Hardness Scale (EHS) six months after intervention | Erectile Hardness Scale (EHS) was answered at baseline and 6 months after intervention. The scale are running from 0-4, it is used to rate erection firmness for penetration. 0: no enlargement at all
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense Universityhospital | Odense | 5000 | Denmark |
The data are stored in 'REDCap' that is government approved for storage of personal data, and is used to keep track of the clinical trial data via the Odense Patient data Explorative Network 'OPEN'. The aforementioned questionnaires regarding the erectile function will be filed out by the patients themselves directly into the REDCap patient file via a link.
1 of January 2018 til 31 of December 2028
Sponsor and primary investigator will be able to access the database. Primary investigator can make permission to access the database by creating a login.
The GCP (good clinical practice) Units investigators can also access the database.
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performed as a randomized, double-blind, placebo-controlled trial
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| Placebo | Other | Injection of ringer lactate |
|
| 6 months |
| RigiScan | Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored Frequency of erections during sleep (number of erections) | 6 months |
| RigiScan data | Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored duration of erection during sleep in minutes. | 6 months |
| RigiScan data | Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored tumescence of erection, the expansion of the circumference in cm. | 6 months |
| RigiScan data | Changes in RigiScan scores 6 months after intervention. RigiScan is a non- invasive diagnostic devise that are used to measure penile rigidity and circumference changes during sleep. The divice consist of two loops and a monitor, and the loops are able to monitor the erection quality over time, if the values of the data improve 6 months after intervention, is the erection improved. We monitored hardness of erection in % | 6 months |