Table 29Penile Fibrosis in Studies of Intracavernosal Injection (Non-randomized)

StudyStudy DesignPatientsTreatment(s)Treatment DurationFibrosis % (n/N)
by Treatment Group
Perimenis 2006Clinical trial38 Greek men
Mean age 56.4 (range 42–62) years
With diabetes mellitus (DM) (type I and II)
1.

Prostaglandin (PGE1) 5–20 μg

2.

Papaverine (PAP) ≥8 mg

3.

PGE1 + PAP 20 μg/ 8 mg

10 years13.2% (5/38)
Althof 1991Clinical trial42 American men, mean age 54.4 yearsPAP + phentolamine, NR12 months26%
Canale 1996Clinical trial68 Italian men, mean age 50.5 (22–70) yearsPGE1,20 μg/ml /wk (20–60 μg/2–3 d in one case)> 12 months4.4% (3/68)
Porst 1998Clinical trial162 European men, mean age 54 (22–70) yearsPGE1, NR1– 4 y11.7% (19/162)
1st y: 6.8%
2nd y: 2.5%
3rd y: 7.3%
4th y: 1.7%
Claro 2001Retrospective cohort168 Brazilian men, median age 61 (43–78) years, had undergone prostatectomy for localized prostate cancer
1.

PAP + Phentolamine (PHEN) + PGE1 22.6 mg / 1.34 mg/ 13.4 mg

NR0%
Lepore 2001Clinical trial52 Italian men,
mean age 56.7 (range 35–74) years
With diabetes
1.

PGE1 NR

2.

Sildenafil

3 months0%
Perimenis 2001Clinical trial40 Greek men
18 diabetic and 22 non-diabetic controls Mean age 55.6 (48–64)
1.

PGE1 5–20 μg

2.

PAP 8–16 mg

3.

PGE1 + PAP 20 μg/ 8–16 mg

7 years17.5% (7/40)
One non-diabetic control developed early Peyronie's plaque leading to study withdrawal
Wespes 2000Clinical trial10 Belgian men, mean age 56.5 (46–69) years1. PGE1 6–20 ugNR0%
Shmueli 1999Clinical trial452 Israeli men,
mean age 59.5 (26–85) years
Protocol I: PAP + PHEN 6–25 mg/ 0.05–1.5 mg. Patients who failed received
Protocol II: PGE110–25 μg. Patients who failed received
Protocol III: PAP + Phentolamine + PGE1 Patients who failed received
Protocol VI: PAP + Phentolamine + PGE1+ atropine 0.02–0.06 mg
6 months0%
Small nodules
Protocol I: 0.6% (3/452)
Protocol II: 2% (3/147)
Protocol III: 3.5% (3/86)
Protocol IV: 9.7% (3/31)
Chew 1997Retrospective cohort245 Australian men,
mean age 62 (21–79) years, hypertension (22.8%), DM (8.5%)
1.

PGE12–60 μg (mean 13 μg)

2.1 years
(up to 86 months)
23.3% (57/245)
Sundaram 1997Retrospective cohort160 American men
Age not reported
1.

PAP 30 mg

2.

PAP + PHEN 25 mg + 0.83 mg

3.

PGE1 NR (alternative therapy)

1–5 years<1%
(1 patient)
Gupta 1997Retrospective cohort1089 American men,
mean age 62 (21–94) years
1.

PGE15–10 μg

2.

TRIMIX 4.41 mg/ 0.5 mg/ 1.47 μg

3.

PGE1 + PAP 5–10 μg/ 30 mg

4.

PAP + PHEN 30 mg/ 0.5 mg

Up to 80 monthsPenile scarring/nodules in patients discontinuing therapy
1.

PGE110.7% (8/75)

2.

TRIMIX 23.1% (6/26)

3.

PAP + PHEN 11.1% (4/36)

Flynn 1996Retrospective cohort126 British men,
mean age 57 (27–77) years, 40% had co-morbidities
1.

PAP NR

2.

PAP + PHEN NR

3.9 years<1% (1 subject)
Chen 1996Retrospective cohort92 American men,
mean age 58.6 (32–78) years, 67% had co-morbidities
1.

PGE1 initial dose <10 μg/ml in most cases

1–56 months16.3% (15/92)
Bolayir 1994Clinical trial40 Cypriot men,
age range 40–75 years
1.

PAP + Verapamil 20–35 mg/5 mg

1 year
2.5% (1/40)
Hattat 1994Clinical trial69 Turkish men,
mean age 52.6 (31–71) years
1.

PGE1 NR

2.

PAP NR

13.6 months3.6% (2/56) PAP
0 (0/13) PGE1
Betts 1994Clinical trial46 British men,
mean age 39 (26–58) with multiple sclerosis
1.

PAP 10–80 mg

NR2.2% (1/46)
Chiang 1992Clinical trial51Taiwanese men,
mean age 58.3 (29–79) years
1.

PGE1 5–40 μg

2.

PAP 15–60 mg

1 year
3.9% (2/51)
Kerfoot 1991Retrospective cohort119 American men
Group 1 (n = 65): Geriatric (>65), mean age 70 years
Group 2 (n = 54): younger, mean age 47
1.

PAP + PHEN 30 mg / 1.0 mg (titrated up to 1.5 if no response)

> 6 months2.5% (3/119)
Schramek 1990Clinical trial
149 Austrian men, Mean age 56.5 (25–76) years
1.

PGE1 10–40 μg

NR0%

From: 3, Results

Cover of Diagnosis and Treatment of Erectile Dysfunction
Diagnosis and Treatment of Erectile Dysfunction.
Evidence Reports/Technology Assessments, No. 171.
Tsertsvadze A, Yazdi F, Fink HA, et al.

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