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Sexual and Reproductive Health

Surgical Penile Implants

Surgical implantation of a penile prosthesis is one option for erectile dysfunction which involves inserting an implant into the erectile tissue. Different types exist including malleable (semi-rigid) and inflatable (hydraulic).

Author Year; Country
Score
Research Design
Total Sample Size
Methods Outcome
Overgoor et al. 2015;
The Netherlands
Case series
Level 4
N=30
Population: 30 low spinal lesion (T12
(incomplete) to sacral) patients (mean
age=29.5 years, range=13-59 years), 13
with spina bifida and 17 with a spinal cord
injury.
Treatment: Researchers wanted to test
whether self-report of reflex erections (RE)
or bulbocavernosus reflex (BCR) testing
was sufficient to determine whether patients
should have unilateral or bilateral (surgery)
to maximize sexual function.
Outcome Measures: The integrity of the
sacral-reflex-arc and DNP function was
tested pre-operatively using bilateral
needle electromyography (EMG)–
bulbocavernosus reflex (BCR)
measurements, and an interview about
reflex erections (RE) ability.
1. Neither Self-report of RE nor BCR
testing can independently predict which
surgery protocol should be used (7
patients reported RE, 4 of which had
positive bilateral BCR; 9 patients had
positive BCR, 4 of which had RE.)
2. No significant association between
BCR function and RE.
Overgoor et al. 2014
The Netherlands
Case series
Level 4
N=40
Population: 40 low-spinal lesion men with
no penile but intact groin sensationMethodology: The “TOMAX” (TO MAXimize sensation, sexuality, and quality of
life) procedure restores genital sensation in
men with low spinal lesions, improving
sexual health, as shown previously. It
connects the dorsal nerve of the penis to
the intact ipsilateral ilioinguinal nerve,
unilaterally or bilaterally. This study reports
on the technical aspects based on 43
TOMAX nerve transfers. 43 nerve transfers
were performed on the participants.Outcome Measures: Data on patient
selection, surgical history, anatomy of the
ilioinguinal nerve and dorsal nerve of the
penis, unilateral or bilateral surgery, surgical
technique, complications, and patient
information were collected prospectively.
1. Regardless of origin, all patients with
no penile but good groin sensation are
eligible for the procedure, provided the
ilioinguinal nerve is not damaged
because of former inguinal surgery or
absent because of anatomical
variations.
2. Selection of a unilateral or bilateral
procedure depends on the presence
or absence of reflex erections and
bulbocavernosus reflex.
3. Preliminary experience with the first
three bilateral cases shows that it is
technically feasible, with encouraging
results. The surgical technique has
evolved (described in detail, including
video) to enhance outcome and
reduce complications.
4. The TOMAX procedure can then be
used to restore erogenous penile
sensation and improve the quality of
sexual health in patients with absent
penile but good groin sensation.
Kim et al. 2008;
Korea
Case series
Level 4
N=48
Population: 48 participants with SCI and
erectile dysfunction, mean age 58.9 (range
39-74).
Treatment: malleable penile prosthesis
insertion.
Outcome Measures: Subjective
satisfaction questionnaire; possibility of
intercourse.
1. 38 (79.2%) of the participants reported
some degree of satisfaction with their
prosthesis.
2. Intercourse was possible in 44
participants.
3. Complications occurred in 8
participants: 4 had infections, 2 had
erosion towards the urethra and glans,
1 experienced pain due to the insertion
of an overly large prosthesis, and 1 was
dissatisfied with the small size of the
inserted prosthesis.
Zermann et al. 2006;
Germany
Case series
Level 4
N=245
Population: Men with neurological
impairment, n=197 with SCI; Age: mean
40.8 yrs, range 17-75; Injury level:
paraplegia (n=188), tetraplegia (n=57);
Diagnostic groups: urinary management
(n=134), erectile dysfunction (ED) (n=60),urinary management and ED (n=51).
Treatment: Penile prosthesis: semirigid
Jonas (n=147), self-contained inflatable
AMS Hydroflex or AMS Dynaflex (n=113),
and inflatable 3-piece AMS 700 CX (n=33).
Outcome Measures: Sexual intercourse
success, treatment satisfaction, secure
condom fixation, urinary management,
adverse events.
1. Sexual intercourse was possible in
83.7% of individuals with penile
prosthesis for ED.
2. 67% of female were satisfied with
result of their partner’s treatment.
3. Adverse events: infection rate 5%,
perforation rate 18.1% (semi-rigid
Jonas), 2.4% (self-contained inflatable
Dynaflex), and 0% (inflatable 3-piece
AMS 700), respectively.
Gross et al. 1996;
Germany
Case series
Level 4
N=209
Population: Men with SCI; Age: mean
39.9 yrs, range 16-72; Injury level:
paraplegia (n=128), tetraplegia (n=38);
Impairment: erectile dysfunction (n=49),
penile retraction (n=113), both (n=47).
Treatment: Penile prosthesis.
Outcome measures: Use of prosthesis,
satisfaction with sexual intercourse,
adverse events.
1. Use of prosthesis: 83 out of 96 men
with ED used prosthesis at 5 yrs after
surgery.
2. Satisfactory sexual intercourse was
reported by 84% of men with ED.
3. Adverse events: perforation in 7% of
men: 9.4% occurred with semi-rigid
prosthesis vs 2.7% of semi-flexible
prosthesis, infection in 5.6% leading to
removal of prosthesis.
Collins & Hackler 1988;
USA
Post-test
Level 4
N=63
Population: 63 men with SCI.
Treatment: Penile implantation of semirigid device or Mentor inflatable prosthesis.
Outcome Measures: Penile implantation
functionality.
1. 53 patients with a semi-rigid implant,
44 currently have functional prosthesis
(83% overall success rate).
2. 10 patients received inflatable penile
prostheses: 4 were lost, 2 had
successful reimplantation.
3. Overall complication rate in the 63
patients=33% (lost prosthesis).
4. After reimplantation, 52/63 patients
had functional device, resulting in 82%
ultimate success rate.
Iwatsubo et al. 1986;
Japan
Case series
Level 4
N=37
Population: Men with SCI, Age: mean 42
yrs, range 21-63, Injury level: tetraplegia
(n=10), paraplegia (n=23), cauda equina
lesions (n=4).
Treatment: Shirai-type silicone implants;
follow up from 6-46 months.
Outcome measures: Impact on sexual
function, adverse events.
1. Impact on sexual function: 15 (41%)
men reported improvement, 18 (48%)
men reported no sexual benefit, 4
(11%) men were dissatisfied.
2. Adverse events: extrusion of
prosthesis due to infection (n=2) and
removal due to causalgia in LE (n=1),
posterior migration of prosthesis (n=1).
Green & Sloan 1986;
USA
Observational
Level 5
N=40
Population: 40 men; Age range: 21-60
yrs, Impairment grade: AIS A (n=31), B-D
(n=9).
Treatment: Penile prosthesis.
Outcome Measures: Sexual
questionnaire.
1. 31 patients have intercourse regularly
and pleased with decision to have
device.
2. 4 patients dissatisfied all had semirigid implant.

Discussion

There are no RCT studies in this area. Penile prostheses have been used for over 25 years to treat ED, penile retraction (or a combination of both) or for improvement in urinary management in selected men with SCI. Generally, for ED, this option was considered after failure of more conservative treatments, including ICI of vasoactive substances, vacuum devices and, more recently, oral PDE5i. Five case-series reports and one cohort study in over 500 men with SCI have revealed a high level of satisfaction with the use of penile prostheses for the treatment of ED, making intercourse possible in almost 85%, as well as resolution of urinary management issues in 90% of patients. In addition, in one study (Zermann et al. 2006), 67% of females interviewed were satisfied with results of treatment of their partner’s ED. Inflatable prostheses (although more expensive) are often preferred over semi-rigid malleable prosthesis as the semi-rigid prosthesis is more difficult to conceal due to the permanence of the erection. These factors, although affecting preference, have not altered the overall satisfaction rates associated with malleable prostheses (Kim et al. 2008).

However, serious complications may occur in about 10% of patients, including infection (4-8%) and perforations depending on implant type (9-18% of semi-rigid devices vs 0-2.7% of semi-flexible/inflatable devices). It has been suggested that the insertion of smaller diameter prosthesis in patients performing clean intermittent catheterizations is more appropriate to reduce the resistance at the time of catheter insertion and potential urethral erosion. Results of two larger studies (Gross et al. 1996Zermann et al. 2006) have shown that improvements over the last 10 years in device design (with the introduction of softer implant materials), surgical approach (infrapubic rather than subcoronal) and infection control measures (broad-spectrum antibiotic prophylaxis and whole body disinfection) have dramatically reduced the likelihood of these complications occurring. Under these improved circumstances, implantation of a penile prosthesis appears to be a relatively safe and viable option, perhaps best reserved for when reversible ED therapies have failed or for those men (or their partners) who find other alternatives, such as intracavernosal injections unacceptable. This decision requires careful consideration in view of the fact that if explanation of penile prosthesis is necessary, the person may no longer be a candidate for other treatment options, such as ICI or a VCD, due to possible extensive penile damage and scarring.

Conclusion

There is level 4 evidence (Kim et al. 2008Zermann et al. 2006Gross et al. 1996) which suggests the use of penile prostheses as treatment for erectile dysfunction (ED) in men with SCI when other ED treatments have failed.

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