Drug Studies
Studies with TriMix-gel™ in Men Who Failed Phosphodiesterase Inhibitors
Abstract:
Introduction and Objective:
Trimix (papaverine, phentolomine and PGE1) has been prepared by
compounding pharmacists and used for intracavernous injections.
After mixing, the shelf life is limited and refrigeration is
recommended. As an altenative, topical TriMix-gel™ seemed more
stable and easier to use, but the results were poor due to limited
absorption. Recently, we evaluated a new TriMix-gel™ for
administration at the urethral meatus. In this report, Erection
Hardness Scores (EHS) and penile rigidity studies were recorded after
the gel on 42 men with mixed morbidities who failed with PDE5 oral
agents. Methods: Sixteen men were on
antihypertensive meds, 12 had type II diabetes, 8 had high cholesterol
and 6 were post radical prostatectomy. Ten men had
comorbidies. Prior to the gel, an EHS was recorded for the
experience with oral agents. The trimix active ingredients and
0.3ml of gel were maintained in separate interlocking syringes at room
temperature until the time of use. The final preparation was
completed by vigorous mixing between the interlocking syringes.
The mixed gel was inserted painlessly into the urethral meatus and the
patient massaged the outer glans for 2 minutes to promote
absorption. There was no other form of stimulation. After
the gel, an EHS was recorded for each patient. In addition, 9 had
measurement of buckling pressures and 7 had rigiscans. Results:
For all 42 patients (mean age 55.2 yrs) the EHS was recorded as 1 for
the oral agents (penis was larger but not hard), but 22 of these
patients actually had no increase in size. After the gel, the
mean EHS was 2.2, but 11 patients had an EHS of 3 (26.1%) and 6 had a 4
(16.6%). Thus, 40.4% of the study group had erections that were
sufficient for penetration. In those with an ESH of 4, the
buckling pressure was >90mm Hg. The rigiscans provided real
time information about the gel response and documented some tumescence
in all cases. In a comparison of 3 and 4 scores, oral agents vs.
gel, X² = 10.0, df 1, p<0.001. Conclusions:
TriMix-gel may have several advantages over oral agents and
intracavernous injections. The active ingredients and gel may be
carried by the patient at room temperature. The shelf life is
long because the active ingredients are mixed only at time of
use. The interlocking syringes permit thorough mixing.
Administration is painless and massage of the glans may enhance mucosal
absorption. Even without stimulation by a partner or videos,
these patients demonstrated statistical significant greater EHS with
gel versus oral agents. These pilot data support the use of
TriMix-gel for ED, but more prospective trials are needed.
The abstract has been published in the Journal of Urology Supplement, J. Urol. 179 (4): 431, 2008.
Author Disclosure Information:
Joel L. Marmar, M.D., Robert Wood Johnson Medical School at Camden NJ and the Department of Urology, Cooper University Hospital, Camden, NJ
Thomas J. Harkins, M.A.., TriMix Laboratories, Cherry Hill, NJ
John Riordan, M.D., Robert Wood Johnson Medical School at Camden NJ and the Department of Urology, Cooper University Hospital, Camden, NJ
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