Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06350019 |
| Other study ID # |
26379996/91 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2013 |
| Est. completion date |
December 25, 2014 |
Study information
| Verified date |
April 2024 |
| Source |
Ankara Yildirim Beyazit University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: The aim of this study is to measure the effects of penile revascularization surgery
performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to
determine the importance of vascular parameters in postoperative patient follow-up.
Methods: A total of 35 participants who underwent penile revascularization surgery due to
vascular ED were included in this study. In the preoperative period and at the 3rd
postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate
cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA)
separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity
(EDV), and resistive index (RI) were measured. The International Index of Erectile Function
questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd
postoperative month. The relationship between changes in (IIEF) questionnaire score and
penile vascular hemodynamic changes in the postoperative period was evaluated.
Description:
A total of 35 participants who underwent penile revascularization surgery with the diagnosis
of vascular ED in our clinic were included in this study. Detailed anamnesis of the cases was
taken, including age, duration of ED, comorbidities that may cause ED, previous trauma,
medical or surgical history and lifestyle. After the physical examination, IIEF 5/15
questionnaires were filled out. In order to exclude hypogonadism, follicle stimulating
hormone(FSH), luteinizing hormone(LH), total testosterone and prolactin levels were measured
in the preoperative period. PCDU, CC-EMG and cavernosometry tests were applied to all
participants in the preoperative period. Participants that did not benefit from
phosphodiesterase 5 inhibitors(PDE-5I) and intracavernosal alprostadil injection used in the
preoperative period were included in the study. Cases with a history of urogenital, rectal
and similar operations that may affect erectile functions, cases with penile pathologies such
as Peyronie's disease, and cases with ED of neurogenic and psychogenic origin were excluded
from this study. After the 3rd postoperative month, participants were interviewed face to
face. During these follow up, the patients were re-evaluated with the IIEF-5/15
questionnaires, and PCDU and computurized tomography angiography (CTA) was performed.
PCDU technique: The PCDU was performed in a quiet and comfortable room for the participants'
comfort. For the diagnosis of arterial insufficiency or veno-occlusive disease, PCDU(B-K
Medical, Herlev, Denmark) was performed with the patient lying in the supine position. First,
gray scale imaging of the flaccid penil shaft in transverse and sagittal planes was performed
to exclude intracavernosal fibrosis and calcifications. Then, 60 mg papaverine hydrochloride
(Papaverine HCl®, Galen Medical Industry, Turkey) was injected laterally into any of the
corpus cavernosum with a 22 Gauge needle. 20 minutes after papaverine HCl injection, PCDU was
performed with an 8 Megahertz (MHz) linear probe at an angle of approximately 45 degrees.
PSV, EDV, RI values of both cavernosal arteries and anastomosis region were calculated.
Measurements were repeated at 5-minute intervals and continued for 30 minutes. Participants
with PSV<25 cantimeters/second (cm/s) were interpreted as arterial insufficiency, and
participants with PSV>25 cm/s, EDV >5 cm/s and RI<0.85 were interpreted as veno-occlusive
disease. RI was calculated with the formula [RI=(PSV-EDV)/PSV]. Participants were warned
about the risk of priapism after papaverine HCl injection and were asked to immediately
consult the clinic if the erection persisted after four hours.
CC-EMG technique: Penil cavernous electrical activity (CEA) was recorded using a high-speed
electromyography module equipped with a computer (Medical Measurement Systems, Enschede, the
Netherlands). The sampling frequency was 200 Hertz (Hz), and a band-pass filter with a cut-off
frequency of 0.1-20 Hz was used. During the CC-EMG recordings, monopolar needle electrode was
used to measure the CEA. A grounding electrode was placed to the participants' foot to avoid
electrical activity simultaneously originating from non-penil areas. It appears as a single
line in the CC-EMG recording. CC-EMG recordings were started after the participants rested
for 10 minutes in a quiet and dim room. CEA potentials were recorded for 10 minutes. Later
the CEA potentials of the penil cavernous nerves was assessed by detecting the peak-to-peak
amplitudes. Ten minutes later, papaverine HCl (60 mg) was injected into a single cavernous
body for avoiding the pattern of discoordination, which manifested by an increase or no
difference in the CEA recording following the injection and suggested the neurogenic ED.
Participants with a discoordination pattern were not included in the study. The relaxation
degree (RD) was calculated using the formula: RD=Pre-injection CEA-Post-injection
CEA/Preinjection CEA×100, as previously described. Participants having less than 50% RD were
excluded from the study.
Cavernosometry technique: After CC-EMG recordings were made, cavernosometry was conducted
with the same device. In the presence of the following criteria, a diagnosis of
caverno-occlusive dysfunction was made.
1. Requires a maintenance flow rate greater than 5 milliliters/minute (ml/m) after revealed
an intracavernous pressure of 150 millimeters-Hg (mmHg) with the artificial erection
test.
2. The intracavernous pressure decreased by a minimum of 45 mmHg within 30 second following
the termination of infusion.
Surgical technique: The operations, were conducted using the Furlow-Fisher procedur, of the
Virag-V technique. Unlike the Furlow- Fisher procedure, the circumflex collaterals were
preserved, and the deep dorsal venous valves were not disrupted by a stripper. After the IEA
was brought to the penil root through the subcutaneous tunnel, an end-to-side anastomosis was
performed with the proximal part of the deep dorsal vein. 7-0 polypropylene suture were used
according to a standard microsurgical procedure. After the anastomosis, the deep dorsal vein
was ligated proximal to the arteriovenous anastomosis. The procedure was performed under
optical magnification (x2.5) to prevent neurovascular bundle damage. In the postoperative
period, intravenous heparin (5000 IU/day) was prescribed for 3 days, 75 mg/day dipyridamole
and 300 mg/day acetylsalicylic acid daily for three months. He was warned not to have sexual
intercourse for 2 months after the operation.
CTA technique: In the third postoperative month, participants underwent CTA. 60 milligram
(mg) papaverine HCl was administered to the subjects 10 minutes before the shooting. A
22-gauge branule was placed in the basilic or cephalic vein of the patient's forearm. Then,
the patient was placed supine on the imaging stretcher and the area to be imaged was
determined. Then, using an automatic injector pump, iodinated contrast material(Iopromide,
Ultravist®, Schering, Germany) was given to the patient intravenously at a dose of 2 mg/kg
and at a flow rate of 3 ml/s. Then, arterial phase pelvic CTA with 2 mm slice thickness was
performed with a 64-detector, multi detector CT machine (Aquilion 64, Toshiba®, Tokyo,
Japan). After CTA examination, sagittal and coronal reformatted images(slice thickness: 1 mm)
were obtained. CT images were evaluated by an experienced radiologist.
