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Erectile DysfunctionNCT06350019

Vascular Effects of Penil revascularızatıon

A study testing Penile revascularızation in people with Erectile Dysfunction and Erectile Dysfunction Due to Arterial Disease, run by Ankara Yildirim Beyazıt University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 23 to 69 years, men only
What is being tested?
Penile revascularızation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
1 Jan 2013to 25 Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 69 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cases that do not benefit from oral phosphodiesterase 5 inhibitor or intracavernosal injection treatment
  • Cases with PSV<25 cm/s in PCDU
  • Cases with PSV>25 cm/s, EDV>5 cm/s and RI<0.85 in PCDU
  • Patients with relaxation degree above 50% in CC-EMG
  • Cases with venous leakage in cavernosometry

Who cannot join

  • hypogonadism (primer or secondary),
  • Cases benefiting from phosphodiesterase 5 inhibitors
  • Cases benefiting from intracavernous alprostadil
  • Those with a history of urogenital, rectal and similar operations
  • Those with Peyronie's disease
  • Cases of neurogenic and psychogenic origin

About this study

Official title: Vascular hemodynamıc Effects of penılle revascularızatıon Surgery and the Role of resıstıve ındex ın Follow-up

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.

Read the 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 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.

Being tested
Penile revascularızation
Keywords
Erectile dysfunction, Penile revascularization, Penile color doppler ultrasonography, Resistive index
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Penile revascularızationProcedure or surgery

    The importance of resistive index in the preoperative evaluation of vascular-induced erectile dysfunction, predicting the success of penile revascularization surgery, and postoperative patient management was investigated.

Study groups in NCT06350019
Study groupRoleWhat they receive
Cases with erectile dysfunction of vascular originExperimentalPenile revascularization surgery was performed in cases with erectile dysfunction of vascular origin. Penile color Doppler ultrasonography, corpus cavernosum electromyography and cavernosometry tests were performed on all cases in the preoperative period and at the 3rd postoperative month. Penile computed tomography angiography was performed at the 3rd postoperative month.
Receives: Procedure: Penile revascularızation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The importance of resistive index in evaluating the postoperative success of penile revascularization

    Penile revascularization was performed in 35 cases with the diagnosis of erectile dysfunction of vascular origin. Both preoperative and postoperative international index of erectile function questionaire (IIEF) and penile color Doppler ultrasound (PCDU) were performed in all cases, and IIEF 5/15 scores and resistive index (RI) were calculated. After the operation, computerized tomography angiography (CTA) was performed to confirm anastomotic patency. The correlation between RI and IIEF was evaluated in the postoperative period. RI = 0.85 was accepted as the limit value to evaluate postoperative success. Cases with RI>0.85 were considered successful and cases with RI<0.85 were considered unsuccessful.

    Measured: 3 months (Postoperative third months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start1 Jan 2013
  3. Primary completion15 Aug 2014
  4. Study completion25 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350019
Sponsor's protocol ID
26379996/91
Status last verified
Apr 2024
First submitted
25 Mar 2024
Last updated
5 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not yet known if there will be a plan to make IPD available

Publications

  • Akdemir F, Kayigil O. Vascular hemodynamic effects of penile revascularization surgery and the role of resistive index in follow-up. Basic Clin Androl. 2024 Dec 20;34(1):28. doi: 10.1186/s12610-024-00243-0.

    PubMed 39701967

Questions about this trial

What is this clinical trial studying?

A study testing Penile revascularızation in people with Erectile Dysfunction and Erectile Dysfunction Due to Arterial Disease, run by Ankara Yildirim Beyazıt University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The importance of resistive index in evaluating the postoperative success of penile revascularization (time frame: 3 months (Postoperative third months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06350019, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.

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