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

Prostate Adenocarcinoma Clinical Trial

Official title:

A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy in Terms of Continence Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05735223
• Other study ID #: LCH-2-092019
• Status: Completed
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: January 15, 2023

Study information

• Verified date: February 2023
• Source: Larkin Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After robotic prostatectomy, besides erectile function and achievement of oncological control, staying dry is also a very important desire expressed frequently by the patients. This has led to the concept of trifecta achievement after robotic prostatectomies. Hence, continence preserving prostatectomies are the order of the day today. Patient acceptance to surgery is low if the continence cannot be assured preoperatively. Many techniques have been promulgated in the last two decades. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: All men undergoing robot assisted laparoscopic radical prostatectomy (RALP). -

Exclusion Criteria:

1. Exposure to androgen deprivation therapy

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. -

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Incontinence Stress
• Prostate Adenocarcinoma
• Urinary Incontinence, Stress

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Larkin Health System	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Larkin Health System

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hammerer P, Huland H. [Urodynamic changes after radical prostatectomy]. Urologe A. 1997 Nov;36(6):535-9. doi: 10.1007/s001200050133. German. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penile Length	Stretched Flaccid Penile Length	10 days post operatively
Secondary	Urinary continence	Pads used.	3 months and 6 months postoperatively