Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 5:44 PM
Study NCT ID:
NCT00906269
Status:
UNKNOWN
Last Update Posted:
2019-05-20
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erectile function domain of Internation Index of Erectile Function (IIEF)', 'timeFrame': '1, 3, 6, 12, and 18 months post surgery'}], 'secondaryOutcomes': [{'measure': 'clinical or biochemical recurrence of cancer', 'timeFrame': 'up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['impotence', 'prostatic neoplasms', 'hyperbaric oxygenation', 'Phosphodiesterase Inhibitors'], 'conditions': ['Impotence', 'Prostatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '15928287', 'type': 'BACKGROUND', 'citation': 'Burnett AL. Erectile dysfunction following radical prostatectomy. JAMA. 2005 Jun 1;293(21):2648-53. doi: 10.1001/jama.293.21.2648.'}, {'pmid': '8858398', 'type': 'BACKGROUND', 'citation': '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': '7120554', 'type': 'BACKGROUND', 'citation': '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': '9187685', 'type': 'BACKGROUND', 'citation': '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': '11113727', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '15592069', 'type': 'RESULT', 'citation': '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': '7714876', 'type': 'RESULT', 'citation': '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': '15310998', 'type': 'RESULT', 'citation': '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': '10524880', 'type': 'RESULT', 'citation': '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': '14713808', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.harthosp.org', 'label': 'Hartford Hospital Home Page'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHypothesis: 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* age 40-69\n* diagnosis of Stage I prostate cancer\n* bilateral NSRRP as primary treatment\n* sexual potency prior to surgery\n\nExclusion Criteria:\n\n* COPD, CHF, diabetes mellitus\n* known inability to tolerate PDE5I\n* confinement anxiety/claustrophobia\n* planned adjuvant or neo-adjuvant therapy\n* patients taking alpha blockers or nitrates\n* patients with retinitis pigmentosa'}, 'identificationModule': {'nctId': 'NCT00906269', 'acronym': 'HBOT', 'briefTitle': 'Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy', 'orgStudyIdInfo': {'id': 'STAF001982HU'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Sildenafil therapy plus post-NSRRP HBO2T', 'type': 'DRUG', 'otherNames': ['Viagra'], 'description': '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.', 'armGroupLabels': ['1']}, {'name': 'Sildenafil therapy plus sham post-NSRRP HBO2T', 'type': 'DRUG', 'otherNames': ['Viagra'], 'description': '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.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'James Graydon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}