New Treatment in Erectile Dysfunction Patients.

June 26, 2022 updated by: Haisam Abdelrhman Ahmed Mohamed, Sohag University

Evaluation the Efficacy and Safety of Hyperbaric Oxygen Therapy in Sildenafil Non Responder Erectile Dysfunction Patients.

Erectile dysfunction patients who are non responder to sildenafil will be treated with hyperbaric oxygen therapy with 100% concentration and at 2 ATM for 30 consecutive sessions each one 90 minutes and then will be reassessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is double blinded randomized controlled clinical trial that includes organic ED patients who attend to the Andrology out patient clinics, Department of Dermatology, Venerology and Andrology, Sohag University hospital, Sohag, Egypt. Informed consent was obtained from all patients. The study was submitted for approval by Ethical and Research committees at Sohag Faculty of Medicine, Sohag University, Sohag, Egypt.

Study design:

Patients were divided into two groups (randomly assigned and comparably cross matched for age). Both patients and the investigators were blinded as regard the treatment until the end of the study.

Group 1: Patients assigned to the HBOT group were treated with (30) sessions in consecutive days (90 minutes of 100% oxygen at 2.2 ATM).

Group 1: Patients assigned to control group were exposed to (30) sessions of air oxygen tension at 2.2 ATM.

All patients were subjected to the following:

  1. Medical history:

    • Personal history: Age, residence, marital status, occupation and special habits of medical importance.
    • ED history: Onset, course and duration.
    • Sexual History: duration of marriage, wife age, frequency of intercourse, morning erection, orgasm, libido, percent of weakness, type and dose of PDE5I and its response after proper instructions and ejaculation.
    • Medical history : History of medical diseases (Hypertension, Diabetes mellitus, Liver disease and any chronic disease).
    • Therapeutic history: previous ED treatment modalities and response to them in addition to other current drug intake.
    • Past history of operations.

  2. General examination:

    It included height, weight, BMI, Blood Pressure, hair distribution, fat distribution and breast examination.

    Blood pressure and pulse.

  3. Local examination:

    Penis: (stretched flaccid length, urethral meatus, deformities and fibrosis). Testes: (site, size, consistency). Spermatic cord. Any scar of previous operations.

  4. Erectile function evaluation:

    4-1- Arabic version of the sexual health inventory for men (SHIM): The SHIM is a five-item scale in which each item is scored from 0 to 5 on four items and 1 to 5 on one item. It includes four of the six items from the original erectile function domain of the IIEF and includes items in maintenance ability, erection confidence, maintenance frequency and erection firmness in addition to a single item on intercourse satisfaction.

    Among men in a relationship with a partner, including those men who have opportunity but no desire to attempt sexual activity or intercourse.

    Disease grades of ED on SHIM scores were categorized as follows: severe ED (SHIM score:1-7), moderate ED (8-11), mild-to-moderate ED(12-16), mild (17-21), and no ED (22-25). A cut off value of 21 was chosen, so that patients with scores of 21 or less were classified as having had ED while patients with scores above 21were classified as having no ED.

    4-2- Arabic version of Erection Hardness Score (EHS): The EHS is a single-item instrument that asks men to rate erection hardness on a scale that ranges from 0 (penis does not enlarge) to 4 (penis is completely hard and fully rigid).

    4-3- The sexual health encounter profile (SEP- Questions 2 and 3): The treatment efficacy evaluated through asking the patients to answer the SEP-Q2 and SEP-Q3 with yes or no.

    SEP-Q2: Were you able to insert your penis into your partner's vagina? SEP-Q3: Did your erection last long enough for you to have successful intercourse? 4-4- Penile color Doppler: Patients evaluated by penile color Doppler after intra-cavernosal injection of 1 ml of Prostaglandin E1 (10 µg/ml). Key parameters included PSV, (cavernosal artery blood flow rate at start of systole) and EDV, (cavernosal artery blood flow rate at the end of diastole.

    PSV <30 cm/s is considered evidence of arterial insufficiency (arteriogenic ED) and EDV >5 cm/s is consistent with venoocclusive ED.

    RI (defined as PSV-EDV/PSV) is an indicator for venoocclusive function assessment. RI >0.80 have been cited as indicative of normal veno-occlusive function.

  5. Laboratory investigations:

    Patients evaluated with random blood sugar, lipid profile after 12 hours fasting, and serum uric acid. A morning 8:00- 10:00 a.m. blood sample collected for measurement of total and free testosterone.

  6. Safety evaluation:

    Safety and tolerability evaluated throughout the course of the study by assessing adverse events reported by either the patient or the physician.

  7. Follow up evaluation:

Patients evaluated at 3 points as follow:

The first initial evaluation, The second evaluation at the end of sessions and The third evaluation 3months after stoppage of sessions.

The evaluation tools were as follow:

Erectile function evaluation: SHIM- EHS- SEP- Penile color Doppler, Laboratory evaluation: Total and free testosterone and Safety evaluation.

Outcome measures:

The outcome measures were: SHIM- EHS- SEP- penile Doppler parameters - response to PDE5i- reported side effects by physician and /or patients.

Statistical analysis:

Data analyzed using Statistical Package for Social Sciences SPSS) software program (version 16). All variables checked for normality.

Quantitative variables with normal distribution presented as means ± standard deviation (SD). While quantitative variables with no normal distribution presented as median (25th-75th percentile). Qualitative variables recorded as frequencies and percentages .

Comparison between continuous variables with normal distribution done by student t- test, while continuous variables with no normal distribution done by Mann-Whitney test. Qualitative variables compared by chi-square test.

Correlations between different variable performed when indicated with appropriate tests. Regression analysis done if indicated.

P value < 0.05 considered significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Faculty of medicine sohag university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with regular sexual relationship in the last 6 months
  • having organic ED and
  • non responder to Sildenafil were included in our study.

Exclusion Criteria:

  • Hypogonadism,
  • History of Pelvic trauma, surgery or disease,
  • Receiving treatment in the last 3 months,
  • History of premature ejaculation,
  • History of spinal cord or brain disease,
  • History of drug abuse,
  • Patients without a regular sexual partner,
  • Patients with advanced kidney disease (creatinine>1.3 mg\dl) or liver disease,
  • History of psychiatric diseases,
  • HBOT exclusion as open pneumo-thorax, chest disease, sezure and congestive heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 100% oxygen
ED patients in this group exposed to hyperbaric oxygen 100 % concentration at 2.2 ATM for 90 minutes for 30 consecutive sessions.
Device: hyperbaric oxygen therapy within hyperbaric oxygen therapy chamber.
ED patients in this group exposed to hyperbaric oxygen 100 % concentration at 2.2 ATM for 90 minutes for 30 consecutive sessions.
Placebo Comparator: ordinary room oxygen
ED patients in this group exposed to normal air oxygen concentration at 2.2 ATM for 90 minutes for 30 consecutive sessions.
Device: hyperbaric oxygen therapy within hyperbaric oxygen therapy chamber.
ED patients in this group exposed to hyperbaric oxygen 100 % concentration at 2.2 ATM for 90 minutes for 30 consecutive sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in sexual health inventory for men (SHIM)
Time Frame: Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.

The SHIM is a five-item scale in which each item is scored from 0 to 5 on four items and 1 to 5 on one item. It includes four of the six items from the original erectile function domain of the IIEF and includes items in maintenance ability, erection confidence, maintenance frequency and erection firmness in addition to a single item on intercourse satisfaction.

Among men in a relationship with a partner, including those men who have opportunity but no desire to attempt sexual activity or intercourse.

Disease grades of ED on SHIM scores were categorized as follows: severe ED (SHIM score:1-7), moderate ED (8-11), mild-to-moderate ED(12-16), mild (17-21), and no ED (22-25). A cut off value of 21 was chosen, so that patients with scores of 21 or less were classified as having had ED while patients with scores above 21were classified as having no ED (Shamloul et al., 2004).
Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.
Change in Erection Hardness Score (EHS)
Time Frame: Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.
The EHS is a single-item instrument that asks men to rate erection hardness on a scale that ranges from 0 (penis does not enlarge) to 4 (penis is completely hard and fully rigid) (Arafa and Shamloul, 2009).
Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.
Change in the Sexual health encounter profile (SEP- Questions 2 and 3):
Time Frame: Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.

The treatment efficacy evaluated through asking the patients to answer the SEP-Q2 and SEP-Q3 with yes or no (Tsetsvadz A. et al., 2009).

SEP-Q2: Were you able to insert your penis into your partner's vagina? SEP-Q3: Did your erection last long enough for you to have successful intercourse?
Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Penile color Doppler:
Time Frame: Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.

Patients evaluated by penile color Doppler after intra-cavernosal injection of 1 ml of Prostaglandin E1 (10 µg/ml). Key parameters included PSV, (cavernosal artery blood flow rate at start of systole) and EDV, (cavernosal artery blood flow rate at the end of diastole) (Souper et al., 2017).

PSV <30 cm/s is considered evidence of arterial insufficiency (arteriogenic ED) and EDV >5 cm/s is consistent with venoocclusive ED.

RI (defined as PSV-EDV/PSV) is an indicator for venoocclusive function assessment. RI >0.80 have been cited as indicative of normal veno-occlusive function (Papagiannopoulos et al., 2015).
Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Reham E Alsharkawy, Ass. prof., Sohag university- Faculty of Medicine
  • Study Chair: Amr A Ali, Ass. prof., Sohag university- Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-22-01-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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