update on penile rehabilitation · penile oxygenation oxygen tension in normal flaccid penis –...
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Update on Penile Rehabilitation
Justin Parker, MDAssistant Professor of UrologyUniversity of South FloridaJames A. Haley VA Medical Center
Disclosure
I am a consultant/speaker for Coloplast but have no conflicts regarding this presentation.
Objectives
Discuss the pathophysiology of post prostatectomy erectile dysfunction Understand the limitations of the data
supporting penile rehabilitation protocols Consider possible rehab protocols which
may be utilized in a typical clinical practice
Erectile dysfunction after prostatectomy
Wide range of reported potency rates after radical prostatectomy– Review of RRP series from 1990-2005 with
minimum 12 month followup: 31-86%– Nerve sparing laparoscopic radical
prostatectomy: 42-76%
Dubbelman et al. Sexual function before and after radical retropubic prostatectomy: a systematic review of prognostic indicators for a successful outcome. Eur Urol 2006;50:711–20.
Ficarra et al. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol 2009;55:1037–63.
Robotic prostatectomy and ED
Previously published surgical series showed 12 month potency rates of 70-80%
Ficarra et al. 2012– Systematic review and meta-analysis– 12 month potency rates: 54-90%– 24 month potency rates: 63-94%
4th ICSM 2015 – Insufficient evidence that a specific surgical technique open vs
laparoscopic vs robot-assisted promotes better results for postoperative EF recovery
– Predictors of erectile recovery include but not limited to younger age, preoperative function, and bilateral nerve sparing status
Ficarra et al. Eur Urol 2009;55:1037–63.Ficarra et al. Eur Urol 2012;62:418-430.Salonia et al. J Sex Med 2017; 14;285-296.
Pathophysiology of post prostatectomy ED Course of cavernous nerves more complex than
previously thought– Incomplete nerve sparing- obvious cause
Complete nerve sparing– Nerves likely still affected by direct trauma, stretching,
heating, ischemia, and local inflammation– Temporary neuropraxia
Penile oxygenation
Oxygen tension in normal flaccid penis– 25-43 mmHg
Oxygen tension in normal erect state– 100 mmHg
Temporary neuropraxia– Lack of normal erection cycle– Penile tissue in a constant state of low oxygen supply
due to loss of nocturnal erections– May lead to apoptosis and fibrosis
Penile alterations after nerve injury
Hypoxia results in fibrosis and up-regulation of collagen production
Fibrosis results in veno-occlusive dysfunction and loss of penile length
Fibrosis may be down-regulated with improved oxygenation
Leungwattanakij et al. J Androl, 2003Shaiji et al. Can Uro Assoc J, 2009Mulhall et al. J Sex Med, 2007
Venous leakage
Venous leakage is present:– 14% at 4 months from surgery– 35% at 8 to 12 months from surgery– 50% after 12 months from surgery
Prognosis for return of functional erections is worse when venous leakage is present
Mulhall et al. Journal of Urology, 2002
Concept of penile rehab
Improve cavernosal oxygenation Preserve smooth muscle and prevent fibrosis Preserve endothelial function Improve return of spontaneous erections
Rehabilitation regimens may consist of:– PDE5 inhibitors– Intracavernosal injection– MUSE– Vacuum erection devices
Mulhall et al. J Sex Med, 2007
To rehab or not to rehab?- Practice patterns Teloken et al. J Sex Med 2009
– Web based survey among members of the ISSM– 301 physicians responded– 87% performed some form of penile rehab– Of those who did not suggest or prescribe penile
rehab, primary reason was excessive cost (50%)
But what is the evidence?– 25% of those who do not perform penile rehab stated it
was due to lack of evidence
Alprostadil intracavernosal injection
Montorsi et al: ICI therapy 3x/week– 67% of patients with spontaneous erections– 20% of controls spontaneous erections
Mulhall et al: either sildenafil, or ICI if non-responsive to sildenafil– 52% of rehab patients with improved natural erections
vs 19% of non-rehab– Improved response to sildenafil and ICI in rehab group
Further literature is scarce with major limitations
Montorsi et al. J Urol, 1997Mulhall et al. J Sex Med, 2005
MUSE
Intraurethral alprostadil suppository Raina et al- men received 125 or 250 μg three
times per week vs no ED treatment– 74% in treatment group regained erections satisfactory
for intercourse vs. 37% in the control group– Patients allocated to groups by choice
McCullough et al- 139 men randomized to nightly MUSE or sildenafil– No significant difference between the two group at 1
year– Loss of penile length noted in both groups
Phosphodiesterase Inhibitors
Preclinical animal data showed benefit of PDE5 inhibitors – Decrease erectile tissue fibrosis– Prevent degeneration of nerves– Stimulate neuro-regeneration
Several human trials were performed with contradictory results
Phosphodiesterase inhibitors-conflicting data Padma-Nathan et al.
– 76 patients randomized to nightly sildenafil vs. placebo for 36 weeks
– Spontaneous erectile function good enough for intercourse in 27% vs 4% in the placebo group
– Improved nocturnal erections in the sildenafil group
Montorsi et al.– Double blind RCT evaluating nightly vardenafil vs. on demand– On demand dosing was associated with higher IIEF scores– Unassisted erectile function was not significantly improved for
either group
Phosphodiesterase inhibitors
Data is contradictory Medication is relatively safe
– Well known side effects and comfortable to urologists Current evidence fails to clearly demonstrate
improvement in spontaneous, unassisted erections– But may be better than doing nothing
Cost remains a significant barrier to routine use for many
VED
Preclinical studies– Transient increase in arterial flow and
oxygenation to the corpora cavernosa– Preservation of endothelial and smooth muscle
integrity– With constriction band oxygen saturation drops
• Do not use band in rehab setting
Post- prostatectomy studies– Controversial results
VED
Kohler et al- randomized study of early intervention with VED compared with no treatment after prostatectomy– Higher IIEF scores at 3 and 6 months in VED group
Raina et al- randomized 109 patients to daily VED or no treatment– No significant difference in erectile function– 63% in the no treatment group noted decrease in
penile size vs. only 23% in the VED group
VED combined with PDE5 inhibitors
Basal et al- PDE5’s alone or in combination with VED – Significantly improved postoperative erectile function
recovery but not VED alone Engel- randomized pilot of tadalafil 20mg three
times weekly or tadalafil plus VED– Higher IIEF score in the combination group at 6, 9, and
12 months
VED and penile length
Dalkin and Christopher– Daily use of VED begun day after catheter removal
and continued for 90 days– 39 patients– VED use >50% of days- 1/36 had decrease of
stretched penile length >1cm– VED use <50% of days- 2/3 had decrease of length
>1cm Kohler study
– Stretched penile length was preserved in the VED group compared to no treatment
Penile Rehab- USF protocol
Initiate as early as possible after catheter removal VED- recommend using at least 3-5 times per
week without a constriction band – Cycle intermittently over about 5-10 minutes
Daily or every other day PDE5– 5mg tadalafil or 25mg sildenafil (also consider 20mg
generic Revatio)– If cost an issue then QOD
Initiate ICI for on demand use as soon as patient is ready to resume sexual activity
Penile rehabilitation summary
Overall concept is to maximize tissue oxygenation and prevent fibrosis during period of neuropraxia– Timing is likely important- start as soon as possible to
minimize fibrosis The available data is inadequate to support one
particular protocol over another Makes sense to combine pharmacological and
mechanical methods Helps to make the patient an active participant in
their recovery