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Status unknownNCT03406169Updated Jan 23, 2018

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

A Phase 3 interventional study of Sildenafil 25 MG Oral Tablet and Pentoxifylline in Erectile Dysfunction and Prostate Cancer, sponsored by Brooke Army Medical Center. Status unknown at 1 site in United States. Open to male participants aged 30 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Brooke Army Medical Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
30 Years to 89 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Erectile Dysfunction
  • Prostate Cancer

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Keywords

  • penile rehabilitation
03

Who can participate

Ages eligible
30 Years to 89 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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).
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    Sildenafil 25mg Oral Tablet

    25mg sildenafil citrate twice daily

    Drug: Sildenafil 25 MG Oral Tablet

  • Active comparator
    Pentoxifylline

    400mg pentoxifylline twice daily

    Drug: Pentoxifylline

  • Placebo comparator
    Placebo

    placebo twice daily

    Other: Placebo

Interventions

  • DrugSildenafil 25 MG Oral Tablet

    twice a day dosing

    Also known as: viagra

  • DrugPentoxifylline

    400mg twice a day

    Also known as: trental

  • OtherPlacebo

    placebo twice a day

05

What researchers measure

Primary outcomes

  1. Erectile function

    As measured by IIEF

    Time frame: 12 months post surgery

Secondary outcomes

  1. Penile length

    Stretched length in cm from pubis to coronal ridge

    Time frame: 12 months post surgery

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03406169
Lead sponsor
Brooke Army Medical Center
Collaborators
Walter Reed National Military Medical Center
Responsible party
Kuwong B Mwamukonda (Staff Urologist, Brooke Army Medical Center) — Principal investigator
First posted
Jan 23, 2018
Start date
Feb 13, 2017
Primary completion
Dec 2021 (estimated)
Completion
Mar 2022 (estimated)
Last update
Jan 23, 2018

Study contacts

Janet Schadee, RN
Contact
janet.s.schadee.civ@mail.mil
210 916-1640
Pansy Uberoi, MD
Contact
pansy.uberoi.mil@mail.mil
210 916-1163
Kuwong B Mwamukonda, MD
principal investigator · Brooke Army Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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