Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy
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|ClinicalTrials.gov Identifier: NCT03406169|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
400mg twice a day
Other Name: trental
Placebo Comparator: Placebo
placebo twice daily
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
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 email@example.com|
|Contact: Pansy Uberoi, MD||210 firstname.lastname@example.org|
|United States, Texas|
|Brooke Army Medical Center||Recruiting|
|San Antonio, Texas, United States, 78234|
|Contact: Ileana King-Letzkus 210-916-2000 email@example.com|
|Principal Investigator:||Kuwong B Mwamukonda, MD||Brooke Army Medical Center|