Clinical trial · Interventional
Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer
Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy
NCT00906269CI-TRIAL-00038695HBOTunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that delivers oxygen under slight pressure, to a drug treatment of PDE5I (such as Viagra, Levitra, Cialis)for men following surgery for prostate cancer will result in more men being able to continue to have erections.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Impotence | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sildenafil therapy plus post-NSRRP HBO2T | Drug | — | UNRESOLVED |
| Sildenafil therapy plus sham post-NSRRP HBO2T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Sildenafil therapy plus post-NSRRP HBO2T
- type
- SHAM_COMPARATOR
- label
- 2
- interventionNames
- Drug: Sildenafil therapy plus sham post-NSRRP HBO2T
Primary outcomes (1)
- measure
- Erectile function domain of Internation Index of Erectile Function (IIEF)
- timeFrame
- 1, 3, 6, 12, and 18 months post surgery
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * male * age 40-69 * diagnosis of Stage I prostate cancer * bilateral NSRRP as primary treatment * sexual potency prior to surgery Exclusion Criteria: * COPD, CHF, diabetes mellitus * known inability to tolerate PDE5I * confinement anxiety/claustrophobia * planned adjuvant or neo-adjuvant therapy * patients taking alpha blockers or nitrates * patients with retinitis pigmentosa
References
Publications (12)
- BACKGROUNDBurnett AL. Erectile dysfunction following radical prostatectomy. JAMA. 2005 Jun 1;293(21):2648-53. doi: 10.1001/jama.293.21.2648. PMID 15928287
- BACKGROUNDMulhall JP, Graydon RJ. The hemodynamics of erectile dysfunction following nerve-sparing radical retropubic prostatectomy. Int J Impot Res. 1996 Jun;8(2):91-4. PMID 8858398
- BACKGROUNDWalsh PC, Donker PJ. Impotence following radical prostatectomy: insight into etiology and prevention. J Urol. 1982 Sep;128(3):492-7. doi: 10.1016/s0022-5347(17)53012-8. No abstract available. PMID 7120554
- BACKGROUNDRosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0. PMID 9187685
- BACKGROUNDWei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x. PMID 11113727
- BACKGROUNDFeldmeier, J.J.,Chairman and Editor. Hyperbaric Oxygen 2003: Indications and Results. The Hyperbaric Oxygen Therapy Committee Report . Kensington, MD: Undersea and Hyperbaric Medicine Society, 2003.
- BACKGROUNDFeldmeier JJ. Hyperbaric oxygen: does it have a cancer causing or growth enhancing effect? In: Proceeding of the Concensus Conference sponsored by the European Society for Therapeutic Radiology and Oncology and the European Committee for Hyperbaric Medicine. Portugal 2001: 129-146
- RESULTLink RE, Su LM, Sullivan W, Bhayani SB, Pavlovich CP. Health related quality of life before and after laparoscopic radical prostatectomy. J Urol. 2005 Jan;173(1):175-9; discussion 179. doi: 10.1097/01.ju.0000147190.67218.1b.