A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence
NCT ID: NCT05735223
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2021-09-30
2023-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators present a novel technique of maximal urethral length preservation during surgery as an effective method of continence preservation. The investigators hypothesize that maximal preservation of urethra would lead to improved and early continence after robotic prostatectomy. The investigators also hypothesize that urethral preservation spares penile length shortening. The investigators therefore propose to prospectively evaluate penile length shortening.
While penile length change after radical prostatectomy has been studied in the past, the investigators like to assess the penile morphometric assessment following the novel technique of maximal urethral length preservation radical prostatectomy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Technique Improves Urinary Continence in Patients Undergoing Laparoscopic Radical Prostatectomy
NCT06754488
Retrograde Perfusion Sphinterometry and Autologous Sling to Improve Urinary Continence in Robotic Radical Prostatectomy
NCT03050996
Early Urinary Continence After Radical Prostatectomy: Surgical Procedure and Anatomic Landmarks
NCT04043637
Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction Versus Standard Robot-Assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy Surgery: A Comparative Prospective Study of 300 Patients
NCT06730243
Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.
NCT03302169
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stretched flaccid penile length (SFPL) following RALP.
Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery).
Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery). The subjects were blinded to the measurements to prevent bias. Multiparametric MRI (MP-MRI) of the prostate were reviewed when available for surgical planning. All subjects underwent RALP with MULP using the technique previously published by Hamada et al. Continence defined as requiring no pads was assessed at 3 and 6 months postoperatively.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Maximal urethral length preservation technique of robot assisted radical prostatectomy (RALP).
Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery). The subjects were blinded to the measurements to prevent bias. Multiparametric MRI (MP-MRI) of the prostate were reviewed when available for surgical planning. All subjects underwent RALP with MULP using the technique previously published by Hamada et al. Continence defined as requiring no pads was assessed at 3 and 6 months postoperatively.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Prior treatment for prostate cancer
3. Metastatic prostate cancer
4. History of hypospadias or urethral reconstruction
5. History of penile implant, intracorporal injections, intraurethral suppositories
6. Prior pelvic surgery. -
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Larkin Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Balaji Reddy, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sanjay Razdan, MD, MCh
Role: STUDY_CHAIR
Larkin Health System
Balaji Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Larkin Health System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Larkin Health System
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Frey AU, Sonksen J, Fode M. Neglected side effects after radical prostatectomy: a systematic review. J Sex Med. 2014 Feb;11(2):374-85. doi: 10.1111/jsm.12403. Epub 2013 Nov 25.
Paparel P, Akin O, Sandhu JS, Otero JR, Serio AM, Scardino PT, Hricak H, Guillonneau B. Recovery of urinary continence after radical prostatectomy: association with urethral length and urethral fibrosis measured by preoperative and postoperative endorectal magnetic resonance imaging. Eur Urol. 2009 Mar;55(3):629-37. doi: 10.1016/j.eururo.2008.08.057. Epub 2008 Sep 2.
Kadono Y, Machioka K, Nakashima K, Iijima M, Shigehara K, Nohara T, Narimoto K, Izumi K, Kitagawa Y, Konaka H, Gabata T, Mizokami A. Changes in penile length after radical prostatectomy: investigation of the underlying anatomical mechanism. BJU Int. 2017 Aug;120(2):293-299. doi: 10.1111/bju.13777. Epub 2017 Feb 8.
Hamada A, Razdan S, Etafy MH, Fagin R, Razdan S. Early return of continence in patients undergoing robot-assisted laparoscopic prostatectomy using modified maximal urethral length preservation technique. J Endourol. 2014 Aug;28(8):930-8. doi: 10.1089/end.2013.0794. Epub 2014 Apr 16.
Munding MD, Wessells HB, Dalkin BL. Pilot study of changes in stretched penile length 3 months after radical retropubic prostatectomy. Urology. 2001 Oct;58(4):567-9. doi: 10.1016/s0090-4295(01)01270-5.
Hammerer P, Huland H. [Urodynamic changes after radical prostatectomy]. Urologe A. 1997 Nov;36(6):535-9. doi: 10.1007/s001200050133. German.
Fraiman MC, Lepor H, McCullough AR. Changes in Penile Morphometrics in Men with Erectile Dysfunction after Nerve-Sparing Radical Retropubic Prostatectomy. Mol Urol. 1999;3(2):109-115.
Berookhim BM, Nelson CJ, Kunzel B, Mulhall JP, Narus JB. Prospective analysis of penile length changes after radical prostatectomy. BJU Int. 2014 May;113(5b):E131-6. doi: 10.1111/bju.12443. Epub 2013 Dec 2.
Kwon YS, Farber N, Yu JW, Rhee K, Han C, Ney P, Hong JH, Lee P, Gupta N, Kim WJ, Kim IY. Longitudinal recovery patterns of penile length and the underexplored benefit of long-term phosphodiesterase-5 inhibitor use after radical prostatectomy. BMC Urol. 2018 May 9;18(1):37. doi: 10.1186/s12894-018-0341-8.
Dalkin BL, Christopher BA. Preservation of penile length after radical prostatectomy: early intervention with a vacuum erection device. Int J Impot Res. 2007 Sep-Oct;19(5):501-4. doi: 10.1038/sj.ijir.3901561. Epub 2007 Jul 26.
Vasconcelos JS, Figueiredo RT, Nascimento FL, Damiao R, da Silva EA. The natural history of penile length after radical prostatectomy: a long-term prospective study. Urology. 2012 Dec;80(6):1293-6. doi: 10.1016/j.urology.2012.07.060. Epub 2012 Oct 23.
Kadono Y, Nohara T, Kawaguchi S, Sakamoto J, Makino T, Nakashima K, Iijima M, Shigehara K, Izumi K, Mizokami A. Changes in penile length after radical prostatectomy: effect of neoadjuvant androgen deprivation therapy. Andrology. 2018 Nov;6(6):903-908. doi: 10.1111/andr.12517. Epub 2018 Jul 2.
Briganti A, Fabbri F, Salonia A, Gallina A, Chun FK, Deho F, Zanni G, Suardi N, Karakiewicz PI, Rigatti P, Montorsi F. Preserved postoperative penile size correlates well with maintained erectile function after bilateral nerve-sparing radical retropubic prostatectomy. Eur Urol. 2007 Sep;52(3):702-7. doi: 10.1016/j.eururo.2007.03.050. Epub 2007 Mar 26.
Engel JD, Sutherland DE, Williams SB, Wagner KR. Changes in penile length after robot-assisted laparoscopic radical prostatectomy. J Endourol. 2011 Jan;25(1):65-9. doi: 10.1089/end.2010.0382. Epub 2010 Nov 29.
Brock G, Montorsi F, Costa P, Shah N, Martinez-Jabaloyas JM, Hammerer P, Ludovico GM, Lee JC, Henneges C, Hamidi K, Rossi A, Mulhall J, Buttner H. Effect of Tadalafil Once Daily on Penile Length Loss and Morning Erections in Patients After Bilateral Nerve-sparing Radical Prostatectomy: Results From a Randomized Controlled Trial. Urology. 2015 May;85(5):1090-1096. doi: 10.1016/j.urology.2014.11.058. Epub 2015 Mar 24.
Toussi A, Ziegelmann M, Yang D, Manka M, Frank I, Boorjian SA, Tollefson M, Kohler T, Trost L. Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial. J Urol. 2021 Aug;206(2):416-426. doi: 10.1097/JU.0000000000001792. Epub 2021 Jun 1.
Heo JE, Lee JS, Goh HJ, Jang WS, Choi YD. Urethral realignment with maximal urethral length and bladder neck preservation in robot-assisted radical prostatectomy: Urinary continence recovery. PLoS One. 2020 Jan 13;15(1):e0227744. doi: 10.1371/journal.pone.0227744. eCollection 2020.
Song W, Kim CK, Park BK, Jeon HG, Jeong BC, Seo SI, Jeon SS, Choi HY, Lee HM. Impact of preoperative and postoperative membranous urethral length measured by 3 Tesla magnetic resonance imaging on urinary continence recovery after robotic-assisted radical prostatectomy. Can Urol Assoc J. 2017 Mar-Apr;11(3-4):E93-E99. doi: 10.5489/cuaj.4035. Epub 2017 Mar 16.
Wijkstra PJ, Ten Vergert EM, van Altena R, Otten V, Kraan J, Postma DS, Koeter GH. Long term benefits of rehabilitation at home on quality of life and exercise tolerance in patients with chronic obstructive pulmonary disease. Thorax. 1995 Aug;50(8):824-8. doi: 10.1136/thx.50.8.824.
Savoie M, Kim SS, Soloway MS. A prospective study measuring penile length in men treated with radical prostatectomy for prostate cancer. J Urol. 2003 Apr;169(4):1462-4. doi: 10.1097/01.ju.0000053720.93303.33.
de Rooij M, Hamoen EH, Witjes JA, Barentsz JO, Rovers MM. Accuracy of Magnetic Resonance Imaging for Local Staging of Prostate Cancer: A Diagnostic Meta-analysis. Eur Urol. 2016 Aug;70(2):233-45. doi: 10.1016/j.eururo.2015.07.029. Epub 2015 Jul 26.
Vis AN, van der Poel HG, Ruiter AEC, Hu JC, Tewari AK, Rocco B, Patel VR, Razdan S, Nieuwenhuijzen JA. Posterior, Anterior, and Periurethral Surgical Reconstruction of Urinary Continence Mechanisms in Robot-assisted Radical Prostatectomy: A Description and Video Compilation of Commonly Performed Surgical Techniques. Eur Urol. 2019 Dec;76(6):814-822. doi: 10.1016/j.eururo.2018.11.035. Epub 2018 Dec 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LCH-2-092019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.