The science and the current use of vacuum therapy for ed after radical prostatectomy
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The Science and the current use of Vacuum Therapy for ED after Radical Prostatectomy . Run Wang, MD, FACS Cecil M. Crigler, MD Endowed Chair in Urology Director of Sexual Medicine University of Texas Medical School at Houston and MD Anderson Cancer Center Houston, TX 77030, USA. Introduction.

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The Science and the current use of Vacuum Therapy for ED after Radical Prostatectomy

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The science and the current use of vacuum therapy for ed after radical prostatectomy

The Science and the current use of Vacuum Therapy for ED after Radical Prostatectomy

Run Wang, MD, FACS

Cecil M. Crigler, MD Endowed Chair in Urology

Director of Sexual Medicine

University of Texas Medical School at Houston and MD Anderson Cancer Center

Houston, TX 77030, USA


The science and the current use of vacuum therapy for ed after radical prostatectomy

Introduction

  • Vacuum therapy (VT) uses negative pressure to distend the corporal sinusoids and to increase blood inflow to the penis.

  • VCD: a constricting ring is used at the base of the penis to prevent blood outflow from the corpora cavernosa, and an erection is maintained.

  • VED: without a constrictive ring to increase blood oxygenation (possibly other factors in the blood) in the corpora cavernosa and also to provide stretching effect.


History of vacuum therapy

History of Vacuum Therapy

1874

John King, MD (when there is impotency with a diminution of the size of the male organ, the glass exhauster should be applied to the part)

1917

Otto Lederer (first patent-surgical device to produce erection with vacuum in conjunction with a compression ring)

1960s

Geddins Osbon (popularizing and perfecting the device with personal used the device for more than 20 years)

1982

Erecaid (first FDA approved VED)

1986-1989 (established efficacy and safety profiles)

Nadig /Witherington, MDs

1996

AUA (recommendation in the guidelines as one

of the treatment for organic ED)


The science and the current use of vacuum therapy for ed after radical prostatectomy

Efficacy of VCDs: clinic data

Authors Year Study design Enrollee (follow-up)Results

Nadig et al. 1986 Prospective 35 (8–22 months) >90% achieved adequate erections. 80% use regularly

Witherington 1989 Retrospective 1517 (8.6 months) 92% good erection

Sidi et al. 1990 Prospective 100 (7.9 months) 68% satisfaction rate

Cookson et al. 1993 Retrospective 216 (29 months) 70% use regularly. Quality of erection plus satisfaction 490%

Segenreich et al. 1993 Prospective 150 (25 months) 75% achieved adequate erection. 490% satisfaction rate

Blackard et al. 1993 Prospective 45 (?) 69% satisfaction rate

Meinhart et al. 1993 Prospective 74 (3 weeks) 27% satisfaction rate

Vrijhof et al. 1994 Prospective 67 (?)50% achieved adequate erection

Baltaci et al. 1995 Retrospective 61 (12.8 months) >80% satisfaction rate. 67% effectiveness rate

Bosshardt et al. 1995 Prospective 30 (6 months) Quality of erection 80%

Kolettis et al. 1995 Prospective 50 (?)56% satisfaction rate. An acceptable treatment mode for CVOD

Lewis et al. 1997 Retrospective 5847 (?) 65–83% success

Dutta et al. 1999 Prospective 129 (37 months) High attrition rate (65%). 35% satisfaction rate

Abbreviations: CVOD, corporeal veno-occlusive dysfunction; VCD, vacuum constriction device.

Yuan J, Hoang An, Romero CA, Lin H, Dai Y, Wang R. IJIR 2010 , 22: 211-9


Attitudes and practice patterns of penile rehabilitation

Attitudes and Practice Patterns of Penile Rehabilitation

  • 301 physicians from 41 countries

  • 83.7% performed rehab

  • Rehab strategies:

    - PDE5 inhibitors95.4%

    - ICI75.2%

    - VED30.2%

    - MUSE9.9%

    Reasons to not do rehab:

    - Cost50%

    - No evidence25%

    - not familiar25%


Penile rehabilitation ved

Penile Rehabilitation - VED

  • VED is gaining popularity.

  • MD Anderson evaluated compliance and recovery of penile length and erectile function with programmed use of VED and ICI in patients who underwent unilateral nerve-sparing prostatectomy with or without unilateral sural nerve grafting.


Changes in penile length for patients using ved mean sd cm

Changes in penile length for patients using VED (Mean ± SD cm)

4 mo Compliance 8 mo Compliance 12 mo Compliance

Good Poor Good Poor Good Poor

N 35 5 15 9 10 7

Length 0.4 ± 0.8 -0.3 ± 0.5 0.8 ± 1.5 -0.2 ± 1.7 0.5 ± 06 -0.3 ± 1.5

P value 0.05 0.22 0.32

Compared with 6 week postoperative measurement


Penile rehabilitation ved1

Penile Rehabilitation - VED

  • Raina et al (2006) found 17% vs 11% recovery of erectile function with daily use of VED; and only 23% vs 85% reporting penile shrinkage compared with control in a 9 month study with total of 109 patients.

  • Kohler et al (2007) conducted a multi-centered randomized study to compare early (1 month post nerve sparing RP) to traditional (6 months after surgery) use of the VED. The preliminary results showed that early use of VED for rehabilitation (10 min a day without the constriction ring) significantly improves the IIEF-EF scores and preserves penile length compared to control group.


Penile rehabilitation ved2

Penile Rehabilitation - VED

  • Mean O2 saturation of corporeal blood immediately after VED induced erection was 79.2% compared to 94.5% from artery and 54.7% from vein.

  • 58% of blood with VED induced erection was arterial and 42% of blood was venous in origin.

  • The O2 saturation decreased significantly after 30 minutes with the ring in place. This finding established the rationale that we do not recommend using ring when VED is used for penile rehabilitation purpose.

  • Arterial blood may not only provide oxygen to the corporal tissues, it may also carry other nutrients such as certain growth factors to the tissues.


The science and the current use of vacuum therapy for ed after radical prostatectomy

What is the Mechanism?


The science and the current use of vacuum therapy for ed after radical prostatectomy

Design Rat VED

Principle:

Replicate human VED


Human ved

Human VED


Rat ved

Rat VED

Yuan JH, Westney OL, Wang R. JSM 6(12): 3247-53, 2009.


Pressure rat ved

Pressure-Rat VED

Pressure (mmHg)

Time (5 Min)

Yuan JH, Westney OL, Wang R. JSM 6(12): 3247-53, 2009.


Application rat ved

Application-Rat VED

Yuan JH, Westney OL, Wang R. JSM 6(12): 3247-53, 2009.


Method

Method

The rat bilateral cavernous nerve crush (BCNC) model was used to replicate the pathological change of post radical prostatectomy.

  • Sprague-Dawley rats, weighing 200–250g, were randomly and equally divided into three groups:

  • sham (CN expose surgery only, no nerve crushing, no VED therapy);

  • control (BCNC procedure, no VED therapy);

  • treatment group (BCNC procedure, VED therapy beginning at 2 weeks after BCNC surgery, 5 minutes twice daily with 1 minute duration, Monday to Friday, total VED treatment time four weeks).


Penile sizes

Penile Sizes

Length of the penes

Diameter of the penes

Length (mm)

Diameter (mm)

*

*

0 4W

0 4W

0 4W

0 4W

0 4W

0 4W

Sham

BCNC+VED

BCNC

Sham

BCNC

BCNC+VED


Icp map ratios

ICP/MAP Ratios

1.25

2.5

5.0

7.5

Voltage

ICP/MAP Ratios

**

Control

*

BCNC

BCNC

+

VED

Eur Urol 58: 773-80, 2010


The science and the current use of vacuum therapy for ed after radical prostatectomy

ED after Prostatectomy

Radical prostatectomy

Neuropraxia

Reduction in arterial inflow

Hypoxia

Apoptosis

The veno-occlusive mechanism defect

ED


The science and the current use of vacuum therapy for ed after radical prostatectomy

VED decreases hypoxia

Cavernosal sinoids HIF-1α IHC

Sham

BCNC

BCNC+VED

Eur Urol 58: 773-80, 2010


The science and the current use of vacuum therapy for ed after radical prostatectomy

VED decreases apoptosis

TUNEL assay--cavernosal sinoids

Sham

BCNC

BCNC+VED

Eur Urol 58: 773-80, 2010


The science and the current use of vacuum therapy for ed after radical prostatectomy

VED increases eNOS

Cavernosal sinoids eNOS IHC

Sham

BCNC

BCNC+VED

Eur Urol 58: 773-80, 2010


The science and the current use of vacuum therapy for ed after radical prostatectomy

Cavernosal sinoids α-SMA IHC

Sham

BCNC

BCNC+VED

VED increases α-SMA

Eur Urol 58: 773-80, 2010


The science and the current use of vacuum therapy for ed after radical prostatectomy

VED decreases TGF-β1

Cavernosal sinoids TGF-β1 IHC

Sham

BCNC

BCNC+VED

Eur Urol 58: 773-80, 2010


The science and the current use of vacuum therapy for ed after radical prostatectomy

VED decreases collagen

Cavernosal sinoids Masson’s trichrome stain

Sham

BCNC+VED

BCNC

Eur Urol 58: 773-80, 2010


The science and the current use of vacuum therapy for ed after radical prostatectomy

Hypothesis

VED Therapy

Blood

Neuropraxia

Arterial inflow

Hypoxia

Apoptosis

Veno-occlusive mechanism

Erectile function


Conclusions

Conclusions

  • VED therapy improves erectile function and preserves penile size in rats with BCNC via anti-hypoxic, anti-apoptotic and anti-fibrotic mechanisms.

  • This study provides scientific evidence for VED therapy in penile rehabilitation after radical prostatectomy. This scientific evidence may motivate physicians’ recommendation and improve patients’ compliance.

  • Clinical studies with long-term results using VED for penile rehabilitation are not available at this time.

  • The multi-center, prospective study to compare the effectiveness of VED vs sildenafil in penile rehabilitation after RP should be conducted.


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