Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

January 19, 2018 updated by: Kuwong B Mwamukonda, Brooke Army Medical Center

Patterns of Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy With and Without Penile Rehabilitation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • viagra
Active Comparator: Pentoxifylline
400mg pentoxifylline twice daily
Drug: Pentoxifylline
400mg twice a day
Other Names:
  • trental
Placebo Comparator: Placebo
placebo twice daily
Other: Placebo
placebo twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile function
Time Frame: 12 months post surgery
As measured by IIEF
12 months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penile length
Time Frame: 12 months post surgery
Stretched length in cm from pubis to coronal ridge
12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

Walter Reed National Military Medical Center

Investigators

  • Principal Investigator: Kuwong B Mwamukonda, MD, Brooke Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2017.001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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