NCT00906269

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

11 years

First QC Date

May 19, 2009

Last Update Submit

May 17, 2019

Conditions

ImpotenceProstatic Neoplasms

Keywords

impotenceprostatic neoplasmshyperbaric oxygenationPhosphodiesterase Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Erectile function domain of Internation Index of Erectile Function (IIEF)

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

Secondary Outcomes (1)

  • clinical or biochemical recurrence of cancer

    up to 10 years

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Sildenafil therapy plus post-NSRRP HBO2T

2

SHAM COMPARATOR
Drug: Sildenafil therapy plus sham post-NSRRP HBO2T

Interventions

Sildenafil therapy plus post-NSRRP HBO2TDRUG

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.

Also known as: Viagra
1
Sildenafil therapy plus sham post-NSRRP HBO2TDRUG

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.

Also known as: Viagra
2

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (12)

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

    PMID: 15928287BACKGROUND

  • 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.

    PMID: 8858398BACKGROUND

  • 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.

    PMID: 7120554BACKGROUND

  • 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.

    PMID: 9187685BACKGROUND

  • 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.

    PMID: 11113727BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 15592069RESULT

  • 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.

    PMID: 7714876RESULT

  • 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.

    PMID: 15310998RESULT

  • 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.

    PMID: 10524880RESULT

  • 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.

    PMID: 14713808RESULT

Related Links

MeSH Terms

Conditions

Erectile DysfunctionProstatic Neoplasms

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsProstatic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • James Graydon, MD

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2020

Study Completion

January 1, 2021

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

US(1)