New Treatment in Erectile Dysfunction Patients.

NCT05439486 | Unknown

• 1 other identifier: Soh-Med-22-01-38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

• Change in 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 (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)

  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):

  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 Outcomes (1)

• Change in Penile color Doppler:

  Base line ( before the sessions), at the end of sessions (6 weeks after ) and then 3 months after.

Study Arms (2)

100% oxygen

ACTIVE COMPARATOR

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.

ordinary room oxygen

PLACEBO COMPARATOR

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.

Interventions

hyperbaric oxygen therapy within hyperbaric oxygen therapy chamber. DEVICE

ED patients in this group exposed to hyperbaric oxygen 100 % concentration at 2.2 ATM for 90 minutes for 30 consecutive sessions.

100% oxygen; ordinary room oxygen

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine sohag university

Sohag, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Reham E Alsharkawy, Ass. prof.

  Sohag university- Faculty of Medicine

  STUDY CHAIR

• Amr A Ali, Ass. prof.

  Sohag university- Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Double blinded randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 30, 2022
• Study Start: January 29, 2022
• Primary Completion: August 29, 2022
• Study Completion: October 29, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)