Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erectile Dysfunction Prostate Cancer | Drug: Sildenafil 25 MG Oral Tablet Drug: Pentoxifylline Other: Placebo | Phase 3 |
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 (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 |

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 |
- Erectile function [ Time Frame: 12 months post surgery ]As measured by IIEF
- Penile length [ Time Frame: 12 months post surgery ]Stretched length in cm from pubis to coronal ridge

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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 |
Inclusion Criteria:
- Patients who have had a prostate biopsy positive for prostate cancer.
- Patient must be age 30 - 89 years.
- Patient must be willing to sign the Institutional Review Board approved consent.
- Patient must have had (or be about to undergo) bilateral or unilateral nerve sparing RALP.
- Patient must have an International IIEF equal to or greater than 21.
Exclusion Criteria:
- Patients with known unstable angina, uncontrolled hypertension, congestive heart failure, or cardiovascular accident within the preceding 2 weeks.
- Patients being treated with nitrate therapy.
- Patients with significant renal or hepatic impairment, cerebrovascular disease.
- Patients with prior erectile dysfunction as indicated by the initial IIEF.
- Patients younger than 30 years of age.
- Patients who did/will not have a unilateral or bilateral nerve sparing radical prostatectomy.
- Patients who have had a prior reaction to Sildenafil or pentoxifylline.
- Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc.).
- 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.
- Patients with a history of left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis).
- Patients with resting hypotension (BP < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg).
- Patients with retinitis pigmentosa.
- Patients with a bleeding disorder.
- Patients with active peptic ulceration.
- Patients with conditions that may predispose to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia).
- Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).

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
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 |
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 |
Principal Investigator: | Kuwong B Mwamukonda, MD | Brooke Army Medical Center |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
penile rehabilitation |
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