Erectile DysfunctionPhase 3NCT03406169
Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy
A Phase 3 study testing Sildenafil 25 MG Oral Tablet and Pentoxifylline in people with Erectile Dysfunction and Prostate Cancer, run by Brooke Army Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 89 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Prostate Cancer
- What is being tested?
- Sildenafil 25 MG Oral Tablet and Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 89 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
Ileana King-Letzkus, 210-916-2000, ileana.e.king-letzkus.civ@mail.mil
About this study
Official title: 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.
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.
- Conditions
- Erectile Dysfunction, Prostate Cancer
- Being tested
- Sildenafil 25 MG Oral Tablet, Pentoxifylline, Placebo
- Keywords
- penile rehabilitation
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 25 MG Oral TabletDrug
Also called viagra
twice a day dosing
PentoxifyllineDrug
Also called trental
400mg twice a day
PlaceboOther
placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil 25mg Oral Tablet | Active comparator | 25mg sildenafil citrate twice daily Receives: Drug: Sildenafil 25 MG Oral Tablet |
| Pentoxifylline | Active comparator | 400mg pentoxifylline twice daily Receives: Drug: Pentoxifylline |
| Placebo | Placebo comparator | placebo twice daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function
As measured by IIEF
Measured: 12 months post surgery
Secondary outcomes (1)
Penile length
Stretched length in cm from pubis to coronal ridge
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start13 Feb 2017
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center
- Responsible party
- Principal investigator, Kuwong B Mwamukonda, Brooke Army Medical Center
- Investigators
- Kuwong B Mwamukonda, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406169
- Sponsor's protocol ID
- C.2017.001
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy With and Without Penile Rehabilitation
- ClinicalTrials.gov ID
- NCT03406169
- Acronym / sponsor ID
- C.2017.001
- Conditions
- Erectile Dysfunction, Prostate Cancer
- Keywords
- penile rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- Walter Reed National Military Medical Center
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sildenafil 25mg Oral Tablet | Active comparator | Drug: Sildenafil 25 MG Oral Tablet25mg sildenafil citrate twice daily |
| Pentoxifylline | Active comparator | Drug: Pentoxifylline400mg pentoxifylline twice daily |
| Placebo | Placebo comparator | Other: Placeboplacebo twice daily |
Who may qualify
- Ages
- 30 to 89 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil 25 MG Oral TabletAlso: viagratwice a day dosing | Drug | Sildenafil 25mg Oral Tablet |
| PentoxifyllineAlso: trental400mg twice a day | Drug | Pentoxifylline |
| Placeboplacebo twice a day | Other | Placebo |
Primary outcome
Erectile function
Time frame: 12 months post surgery
As measured by IIEF
1 secondary outcome
Penile length
Time frame: 12 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuwong B Mwamukonda, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil 25 MG Oral Tablet and Pentoxifylline in people with Erectile Dysfunction and Prostate Cancer, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janet Schadee, RN (210 916-1640, janet.s.schadee.civ@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile function (time frame: 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018; AzTrials last refreshed its copy on 31 Oct 2026.