Adipose Derived Stem Cells, ED
Conditions
Brief summary
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.
Interventions
Adipose-derived regenerative cells was injected into the corpus cavernosum.
OTHERPlacebo
Injection of ringer lactate
Sponsors
Odense University Hospital
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
performed as a randomized, double-blind, placebo-controlled trial
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Nervesparing robot assisted RP * Erectile dysfunction for more than a year after RP * Normal erectile function before RP (IIEF-5 \> 22) and postoperative IIEF-5 score 5-20 or EHS 1 * Involved in a monogamous, heterosexual relationship (since questionnaires are only valid for heterosexual relationsships), where both parts are interested in sexual activities * Insufficient effect of standard medical treatment for ED * Subcutaneous adipose deposits on the abdomen \> 120 mL * Performance status 0 * Ability to give informed consent * Proficiency in the Danish language to understand the questionnaires IIEF-5 and EHS
Exclusion criteria
* Problems with general anesthesia * Incontinence after RP * Anti-thrombotic treatment that cannot be discontinued or substituted with heparin * No interest in sexual interaction with a partner * Previous pelvic surgery or radiation * Systemic autoimmune disease * Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in International-Index-of-Erectile-Function 5 12 months after intervention | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Erectile Hardness Scale (EHS) six months after intervention | 6 months | 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 1. Enlarged but not firm 2. Firm, but not hard enough for penetration 3. Hard enough for penetration, but not fully rigid 4. fully rigid and completely hard. A higher score after 6 month means that the erection is better than before intervention. |
| RigiScan | 6 months | 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) |
| RigiScan data | 6 months | 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. |
Countries
Denmark
Outcome results
None listed