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Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03406169
Recruitment Status : Unknown
Verified January 2018 by Kuwong B Mwamukonda, Brooke Army Medical Center.
Recruitment status was:  Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
Kuwong B Mwamukonda, Brooke Army Medical Center

Study Description
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Brief Summary:
The study is a prospective, randomized, double-blind, placebo-controlled drug study to evaluate the pattern of erectile function recovery after robotic assisted laparoscopic prostatectomy (RALP). We hope to illustrate that early and continuous therapy with either Sildenafil citrate or pentoxyfylline after nerve sparing RALP will promote improved erectile function.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Prostate Cancer Drug: Sildenafil 25 MG Oral Tablet Drug: Pentoxifylline Other: Placebo Phase 3

Detailed Description:

Evaluation of erectile function with the International Index of Erectile Function Questionnaire (IIEF) and measurement of penile length any time between the prostate biopsy and 3 days prior to RALP will be performed.

Patients will undergo a unilateral or bilateral nerve sparing-RALP.

Patients will be randomized to receive either 25mg Viagra twice daily, 400mg pentoxifylline twice daily or placebo twice daily, starting on the first postoperative day after surgery and continuing for one year. The biostatistician generates a table of random numbers. 120 subjects anticipated to enroll at Brooke Army Medical Center will be divided into 3 groups, sildenafil, pentoxifylline or placebo. The randomization table will be given to the research pharmacist.

Patients will have their erectile function evaluated at 3 months, 6 months, 9 months, and 12 months with IIEF and sexual intercourse diary. These visits are routine for post-operative care following a RALP, however, completion of the IIEF and sexual intercourse diary are being performed for study purposes.

Patients will stop therapy at 12 months and penile length will be re-measured. Measurement of penile length will be done for study purposes at the standard 1 year post-operative follow up visit.

Patient will undergo a 6 week washout period during which neither drug will be used, then repeat analysis of erectile function with IIEF will be performed, after which they may restart standard erectile dysfunction therapy as desired. This washout period and follow up will be for study purposes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Patterns of Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy With and Without Penile Rehabilitation
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sildenafil 25mg Oral Tablet
25mg sildenafil citrate twice daily
 Drug: Sildenafil 25 MG Oral Tablet
twice a day dosing
Other Name: viagra
Active Comparator: Pentoxifylline
400mg pentoxifylline twice daily
 Drug: Pentoxifylline
400mg twice a day
Other Name: trental
Placebo Comparator: Placebo
placebo twice daily
 Other: Placebo
placebo twice a day


Outcome Measures
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Primary Outcome Measures :
  1. Erectile function [ Time Frame: 12 months post surgery ]
    As measured by IIEF


Secondary Outcome Measures :
  1. Penile length [ Time Frame: 12 months post surgery ]
    Stretched length in cm from pubis to coronal ridge


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must have a prostate
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients who have had a prostate biopsy positive for prostate cancer.
  2. Patient must be age 30 - 89 years.
  3. Patient must be willing to sign the Institutional Review Board approved consent.
  4. Patient must have had (or be about to undergo) bilateral or unilateral nerve sparing RALP.
  5. Patient must have an International IIEF equal to or greater than 21.

Exclusion Criteria:

  1. Patients with known unstable angina, uncontrolled hypertension, congestive heart failure, or cardiovascular accident within the preceding 2 weeks.
  2. Patients being treated with nitrate therapy.
  3. Patients with significant renal or hepatic impairment, cerebrovascular disease.
  4. Patients with prior erectile dysfunction as indicated by the initial IIEF.
  5. Patients younger than 30 years of age.
  6. Patients who did/will not have a unilateral or bilateral nerve sparing radical prostatectomy.
  7. Patients who have had a prior reaction to Sildenafil or pentoxifylline.
  8. Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc.).
  9. Patients with a clinically significant abnormality on preoperative ECG that in the opinion of the investigator may increase the patient's cardiovascular risk in this study.
  10. Patients with a history of left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis).
  11. Patients with resting hypotension (BP < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg).
  12. Patients with retinitis pigmentosa.
  13. Patients with a bleeding disorder.
  14. Patients with active peptic ulceration.
  15. Patients with conditions that may predispose to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia).
  16. Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406169


Contacts
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Contact: Janet Schadee, RN 210 916-1640 janet.s.schadee.civ@mail.mil
Contact: Pansy Uberoi, MD 210 916-1163 pansy.uberoi.mil@mail.mil

Locations
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United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Ileana King-Letzkus    210-916-2000    ileana.e.king-letzkus.civ@mail.mil   
Sponsors and Collaborators
Brooke Army Medical Center
Walter Reed National Military Medical Center
Investigators
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Principal Investigator: Kuwong B Mwamukonda, MD Brooke Army Medical Center
More Information
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Responsible Party: Kuwong B Mwamukonda, Staff Urologist, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03406169    
Other Study ID Numbers: C.2017.001
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kuwong B Mwamukonda, Brooke Army Medical Center:
penile rehabilitation
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Pentoxifylline
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants