AzTrials
AzTrials

ImpotencePhase 4HBOTNCT00906269

Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

A Phase 4 study testing Sildenafil therapy plus post-NSRRP HBO2T in people with Impotence and Prostatic Neoplasms, run by Hartford Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 65 years, men only
Conditions the study is for
Impotence, Prostatic Neoplasms
What is being tested?
Sildenafil therapy plus post-NSRRP HBO2T
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
Jul 2009to Jan 2021
Phase
Phase 4
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 40 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male
  • age 40-69
  • diagnosis of Stage I prostate cancer
  • bilateral NSRRP as primary treatment
  • sexual potency prior to surgery

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hartford Hospital

    Hartford, Connecticut, 06106

Other trials in United States

About this study

Official title: Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy

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.

Read the detailed description

Prostate cancer is the most common non-skin malignancy in men in the United States, with approximately 232,000 diagnoses of adenocarcinoma projected for 2005. More than 150,000 of these men are treated with radical prostatectomy. Common sequelae following successful NSRRP (nerve-sparing radical retropubic prostatectomy)include urinary incontinence and sexual dysfunction. Recent advances in surgery technique and treatment have been made but in spite of aggressive management, recovery of sexual function is incomplete with fewer than one-fifth reporting return to baseline. The etiology of erectile dysfunction following radical prostatectomy results most probably from local surgical trauma and neurapraxia, which leads to corpus cavernosal hypoxemia in the post-NSRRP period. This hypoxemia is believed to impact negatively on the health and maintenance of the smooth muscle cells within the corpus cavernosum. Hyperbaric oxygen therapy (HBO2T) is a unique modality that is able to provide oxygen delivery to tissues that have been damaged by traumatic injury.

Hypothesis: The addition of post-NSRRP hyperbaric oxygen therapy (HBO2T) to a treatment of phosphodiesterase type 5 inhibitor (PDE5I) will reduce the incidence of erectile dysfunction (ED) and urinary incontinence when measured at 1, 3, 6, 12 and 18 months post-NSRRP for Stage I prostate cancer.

Being tested
Sildenafil therapy plus post-NSRRP HBO2T, Sildenafil therapy plus sham post-NSRRP HBO2T
Keywords
impotence, prostatic neoplasms, hyperbaric oxygenation, Phosphodiesterase Inhibitors
Medical subject headings
Erectile Dysfunction, Prostatic Neoplasms

What participants receive

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

  • Sildenafil therapy plus post-NSRRP HBO2TDrug

    Also called Viagra

    Sildenafil (Viagra) 50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP hyperbaric oxygen therapy (90 minutes of 100% oxygen at 2.2ATA (equivalent to the pressure exerted at a depth of approximately 40 feet below sea level). There will be 5 or 10 treatments. The full treatment cycle will be completed within 2 weeks.

  • Sildenafil therapy plus sham post-NSRRP HBO2TDrug

    Also called Viagra

    Sildenafil (Viagra)50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP sham hyperbaric oxygen therapy - 90 minutes at 2.2ATA but instead of 100% oxygen, they will receive air administered via the oxygen hoods, as if they were being administered oxygen. Participants in this group will receive 5 or 10 sham treatment sessions. Full treatment cycle will be completed within 2 weeks.

Study groups in NCT00906269
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: Sildenafil therapy plus post-NSRRP HBO2T
2Sham comparatorNot described
Receives: Drug: Sildenafil therapy plus sham post-NSRRP HBO2T

What is being measured

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

  1. Erectile function domain of Internation Index of Erectile Function (IIEF)

    Measured: 1, 3, 6, 12, and 18 months post surgery

Secondary outcomes (1)

  1. clinical or biochemical recurrence of cancer

    Measured: up to 10 years

Timeline

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

  1. First posted21 May 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2020 (estimated)
  4. Study completionJan 2021 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00906269
Sponsor's protocol ID
STAF001982HU
Acronym
HBOT
Status last verified
May 2019
First submitted
19 May 2009
Last updated
20 May 2019
Results posted
No
Data monitoring committee
No

Publications

  • Burnett AL. Erectile dysfunction following radical prostatectomy. JAMA. 2005 Jun 1;293(21):2648-53. doi: 10.1001/jama.293.21.2648.

    PubMed 15928287

  • Mulhall JP, Graydon RJ. The hemodynamics of erectile dysfunction following nerve-sparing radical retropubic prostatectomy. Int J Impot Res. 1996 Jun;8(2):91-4.

    PubMed 8858398

  • Walsh 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.

    PubMed 7120554

  • Rosen 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.

    PubMed 9187685

  • Wei 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.

    PubMed 11113727

  • Feldmeier, 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.

  • Feldmeier 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

  • Link 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.

    PubMed 15592069

  • Zamboni WA, Brown RE, Roth AC, Mathur A, Stephenson LL. Functional evaluation of peripheral-nerve repair and the effect of hyperbaric oxygen. J Reconstr Microsurg. 1995 Jan;11(1):27-9; discussion 29-30. doi: 10.1055/s-2007-1006507.

    PubMed 7714876

  • Kaufman JM, Graydon RJ. Androgen replacement after curative radical prostatectomy for prostate cancer in hypogonadal men. J Urol. 2004 Sep;172(3):920-2. doi: 10.1097/01.ju.0000136269.10161.32.

    PubMed 15310998

  • Lowentritt BH, Scardino PT, Miles BJ, Orejuela FJ, Schatte EC, Slawin KM, Elliott SP, Kim ED. Sildenafil citrate after radical retropubic prostatectomy. J Urol. 1999 Nov;162(5):1614-7.

    PubMed 10524880

  • Schwartz EJ, Wong P, Graydon RJ. Sildenafil preserves intracorporeal smooth muscle after radical retropubic prostatectomy. J Urol. 2004 Feb;171(2 Pt 1):771-4. doi: 10.1097/01.ju.0000106970.97082.61.

    PubMed 14713808

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sildenafil therapy plus post-NSRRP HBO2T in people with Impotence and Prostatic Neoplasms, run by Hartford Hospital at 1 site in United States.

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: status not confirmed, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Erectile function domain of Internation Index of Erectile Function (IIEF) (time frame: 1, 3, 6, 12, and 18 months post surgery). 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 NCT00906269, which also lists 12 linked publications.

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 20 May 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in