Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350019
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2024-03-25
Brief Title:
Vascular Effects of Penil revascularızatıon
Sponsor:
Ankara Yildirim Beyazıt University
Organization:
Ankara Yildirim Beyazıt University
Study Overview
Official Title:
Vascular hemodynamıc Effects of penılle revascularızatıon Surgery and the Role of resıstıve ındex ın Follow-up
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 515 questionnaires were filled out In order to exclude hypogonadism follicle stimulating hormoneFSH luteinizing hormoneLH 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 inhibitorsPDE-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 Peyronies 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-515 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 PCDUB-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 PSV25 cantimeterssecond cms were interpreted as arterial insufficiency and participants with PSV25 cms EDV 5 cms and RI085 were interpreted as veno-occlusive disease RI was calculated with the formula RIPSV-EDVPSV 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 01-20 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 RDPre-injection CEA-Post-injection CEAPreinjection CEA100 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 millilitersminute mlm 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 x25 to prevent neurovascular bundle damage In the postoperative period intravenous heparin 5000 IUday was prescribed for 3 days 75 mgday dipyridamole and 300 mgday 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 patients 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 materialIopromide Ultravist Schering Germany was given to the patient intravenously at a dose of 2 mgkg and at a flow rate of 3 mls 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 imagesslice thickness 1 mm were obtained CT images were evaluated by an experienced radiologist
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 PCDUB-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 PSV25 cantimeterssecond cms were interpreted as arterial insufficiency and participants with PSV25 cms EDV 5 cms and RI085 were interpreted as veno-occlusive disease RI was calculated with the formula RIPSV-EDVPSV 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 01-20 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 RDPre-injection CEA-Post-injection CEAPreinjection CEA100 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 millilitersminute mlm 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 x25 to prevent neurovascular bundle damage In the postoperative period intravenous heparin 5000 IUday was prescribed for 3 days 75 mgday dipyridamole and 300 mgday 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 patients 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 materialIopromide Ultravist Schering Germany was given to the patient intravenously at a dose of 2 mgkg and at a flow rate of 3 mls 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 imagesslice thickness 1 mm were obtained CT images were evaluated by an experienced radiologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None