Hyperbaric oxygen therapy as a treatment for men with severe erectile dysfunction unresponsive to standard medications
| ISRCTN | ISRCTN25722640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25722640 |
| Sponsors | Cannizzaro Hospital of Catania, Kore University of Enna |
| Funder | Investigator initiated and funded |
- Submission date
- 08/11/2026
- Registration date
- 10/11/2026
- Last edited
- 10/11/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Francesco Pietropaolo
Scientific, Principal investigator, Public
Scientific, Principal investigator, Public
via peschiera 45
Catania
95123
Italy
 ORCID ID |
0009-0002-6180-0012 |
|---|---|
| Phone | +39 3388294371 |
| francesco.pietropaolo@unikore.it; fpietropaolo3@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Placebo |
| Assignment | Single |
| Purpose | Treatment |
| Participant information sheet | 50604 PIS.pdf |
| Scientific title | Hyperbaric oxygen therapy in vascular erectile dysfunction refractory to phosphodiesterase-5 inhibitors: a single-center, randomized, double-blind, placebo-controlled trial with a 12-month follow-up |
| Study acronym | DE-NOVO |
| Study objectives | |
| Ethics approval(s) |
Approved 29/10/2026, L'Ombudsman Uke (via delle olimpiadi 4, Enna, 94100, Italy; +39 935/536536; protocollo@unikore.it), ref: 32375 |
| Health condition(s) or problem(s) studied | Vascular erectile dysfunction |
| Intervention | Active Arm: Patients receive 40 sessions of Hyperbaric Oxygen Therapy (HBOT) at 2.5 atmospheres absolute (ATA). Each session lasts 90 minutes and treatments are performed 5 days a week until the 40-session cycle is completed. Control/Placebo Arm: Patients receive a sham treatment consisting of 40 sessions in the hyperbaric chamber at 1.1 ATA to ensure blinding. Each session lasts 90 minutes, 5 days a week. Follow-up: Clinical evaluations (using the IIEF-5 questionnaire) and penile Doppler ultrasound (to measure Peak Systolic Velocity) are performed at baseline, and subsequently at 3, 6, and 12 months for all study arms. Randomisation: Patients were randomly assigned to the two treatment arms in a 2:1 ratio (treatment vs. control). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/11/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 70 Years |
| Sex | Male |
| Target sample size at registration | 100 |
| Total final enrolment | 200 |
| Key inclusion criteria | 1. At least 6 months of severe vascular erectile disfunction 2. Erectile disfunction non responders to PDE5i 3. Difficulties in penetrating 4. Normal LH, FSH, Testosterone levels |
| Key exclusion criteria | 1. Non vascular erectile disfunction 2. Abnormalities in LH, FSH, Testosterone levels |
| Date of first enrolment | 09/11/2026 |
| Date of final enrolment | 08/04/2027 |
Locations
Countries of recruitment
- Italy
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 10/11/2026 | No | Yes |
Additional files
- 50604 PIS.pdf
- Participant information sheet
Editorial Notes
10/11/2026: Trial's existence confirmed by L'Ombudsman Uke.
