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Sexual and Reproductive Health

Topical Agents

Topical agents to treat erectile dysfunction are applied to the penis or perineal regions and have included hormone-derived medications, as well as vasodilators.

Author Year; Country
Score
Research Design
Total Sample Size
Methods Outcome
Kim et al. 1995;
USA
Prospective controlled trial
Level 2
N=20
Population: 13 men with SCI, 7 non-SCI
Age: range 19-73 yrs, Duration of erectile
dysfunction: range 0.6-27 yrs.
Treatment: Papaverine gel or placebo gel,
dose range: 133-500mg.
Outcome Measures: Safety and efficacyof
topical papaverine gel.
For SCI patients (n=12)
1. 3 patients with papaverine gel had full
erections, but full erections also
occurred with placebo gel.
Kim et al.1995;
USA
Pre-post
Level 4
N=10
Population: Men with SCI (n=9), 1 arterial
insufficiency; Age: mean 33 yrs, range 19-
50; Injury level: cervical (n=4), thoracic
(n=5)
Treatment: Topical prostaglandin E1 to
penis, scrotum, and perineum.
Outcome measures: Color flow Doppler
Ultrasound for cavernous artery diameter
and peak systolic flow velocity, vital signs:
systolic blood pressure (SBP), diastolic
blood pressure (DBP), heart rate (HR),
clinical erection, adverse events.
1. Mean cavernous artery diameter
increased from 0.09 to 0.11 cm.
2. Mean peak systolic flow velocity
increased from 15.4 to 22.8 cm/sec.
3. Clinical erections were observed in 2
men.
4. Vital signs were unaffected by PGE1.
5. No adverse events.
Chancellor et al. 1994;
USA
Post-test
Level 4
N=18
Population: 18 men with SCI, Age: range
19-65 yrs, Level of injury: C7-L3 (15
thoracic).
Treatment: Minoxidil spray, papaverine
injection, or vacuum constriction device
(VCD).
Outcome Measures: Erectile response.
1. Papaverine injections increased
median rigidity 77% (range 30-100%).
Rigidity was significantly less with
minoxidil.
2. Vacuum constriction device changed
rigidity a median of 57% (range 30-
80%).
3. No difference between vacuum
constriction device and papaverine.
4. Patient subjective rating scale was
significantly lower for minoxidil than
vacuum constriction device or
papaverine.
5. Physicians’ subjective ratings were
significantly lower for minoxidil than
other treatments.
Beretta et al. 1993;
Italy
Post-test
Level 4
N=15
Population: 15 men, age range: 20-38 yrs,
Level: T2-L5.
Treatment: Prostaglandin E1 and 2%
Minoxidil solution.
Outcome Measures: Erectile response.
4 patients had complete responses, 5
had partial, 6 had no response.
2. 9 patients with complete/partial
response continued to use minoxidil at
home for 1 month.
3. 26.6% obtained an erectile response
sufficient for vaginal penetration.
Sonksen et al. 1992;
Denmark
Post-test
Level 4
N=17
Population: 17 men, age range: 19-51 yrs,
level: C2-L4, 13 complete, 4 incomplete.
Treatment: Transiderm-Nitro plaster
(10mg/24hrs), which contains 50mg glyceryl
trinitrate.
Outcome Measures: Erectile response.
1. 5 patients had complete responses (full
rigidity), 7 had partial responses (some
rigidity and/or increase in penile
circumference), and 5 had no response
(no noticeable erection).
2. Erection duration (complete response):
20-45 min.
3. 5 (29%) had erections sufficient for
vaginal penetration.

Discussion

There are no RCT studies in this area. Topical agents that cause vasodilation, such as minoxidil, PGE1, papaverine and nitroglycerine, are generally safe yet found to be effective only in a minority of patients (providing an erection sufficient for vaginal penetration in 22-29%), most likely due to inadequate absorption through the tunica albuginia. Kim & McVary (1995), although showing a significant increase in mean cavernous artery diameter and mean peak systolic flow velocity with topical application of PGE1, reported a clinically useful erection in only 2 out of 9 subjects. One study found topical minoxidil spray to be significantly less effective than comparative treatments with papaverine ICI or a vacuum constriction device. Use of topical agents to treat ED seem to have little if any role to play in the SCI population, particularly in view of the efficacy and reliability of PDE5i and ICI.

Conclusion

There is level 2 evidence (from 1 non-randomized controlled trial: Kim and McVary 1995) that shows that the use of topical agents is not effective as treatment for erectile dysfunction in men with SCI.

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