Xiaflex for Treatment of Peyronie's Disease Curvature (Curved or Bent Penis)

Xiaflex (Collagenase) for Treatment of Peyronie’s Disease
Alex Shteynshlyuger MD
Board Certified Urologist
Director of Urology
New York Urology Specialists
2014
www.NewYorkUrologySpecialists.com

What is Peyronie’s Disease?
 Peyronie’s disease refers to scar “plaque” formation in the penis with
resultant curvature of the penis. Most men recognize this as “bent penis”.
 Peyronie’s disease is most likely a result of overt or micro-trauma with
abnormal healing response.
 Genetic predisposition exists and related to scar healing cellular
mechanisms; most commonly coexists with Dupuytren's contracture.
 Natural course varies with spontaneous improvement occurring in 10-15%
of men in the first year.

Management of Peyronie’s Disease
Important to differentiate congenital ‘physiological’ curvature from pathological
curvature of the Peyronie’s disease caused by plaque.
Many men with mild life-long asymptomatic ‘physiological’ curvature or
deflection of the penis seek evaluation / counseling.
If curvature does not cause any symptoms (pain, difficulty with erections, etc)
observation is a reasonable good option.
Initial management in the first year tends to be conservative. For moderate to
severe curvature, Xiaflex can be considered. Surgical treatment is usually
not advisable for most men in the first year.

Treatment Options for Peyronie’s Disease
Prior to Xiaflex, no randomized controlled study of any non-surgical treatment
demonstrated persistent benefit.
Common Treatments that Have been Used:
 Topical verapamil – no benefit as it does not reach the plaque
 Vitamin E – no evidence to suggest benefit
 Colchicine – no evidence to suggest benefit
 Tamoxifen – no evidence to suggest benefit

Treatment Options for Peyronie’s Disease
Injectable verapamil – 30% of men report some benefit in terms of
curvature/pain; no randomized controlled studies that show persistent
benefit; possibility of a placebo effect cannot be discounted. Most
commonly used non-surgical treatment.
PDE5 inhibitors (Viagra, Cialis) – may be beneficial for pain
Pentoxifylline – some evidence to suggest benefit in terms of pain/curvature.
Penile Traction Devices – evidence that they benefit in terms of curvature /
pain.

Surgical Treatment Options for Peyronie’s Disease
Penile Plication
 Effective for mild to moderate curvature without significant plaque
 Penile shortening – an undesirable risk of penile plication
Plaque excision / Grafting
 Effective for correction of Peyronie’s disease.
 Risk of de-novo ED: 30%; risk of venous leak ED – hard to treat
 Penile prosthesis is an effective treatment often combined with plaque
excision/grafting.
Why all the Excitement about Xiaflex?

Xiaflex: a Cure for Peyronie’s?
First FDA approved non-surgical treatment for Peyronie’s Disease
 First treatment to demonstrate benefit in well-designed and powered
Randomized Controlled Trial compared to placebo.
 Xiaflex is injected in the office into the Peyronie’s plaque.
 60% of men experienced improvement
 Xiaflex – collagenase histolyticum – is a naturally occurring enzyme
involved in breakdown of collagen.
 Since collagen is a component of scar tissue, using Xiaflex to break
down abnormal scar tissue formation makes logical sense.

Xiaflex Indications: Who is a Candidate for Xiaflex?
Any man with symptoms of Peyronie’s Disease (curvature, pain)
 Must have palpable plaque (in order to be able to inject into it); US guided
injection can be considered for sufficiently large plaque with symptoms?
 Non-calcified or Mild to moderate calcification of the plaque; men with
more severe calcification are less likely to benefit from Xiaflex.
 At least 30 degree curvature
 Cannot take anticoagulants (high risk of hematoma at baseline)
 Must have adequate erectile function at baseline. Patients with ED poorly
responsive to oral treatment are better served with penile prosthesis.

Evaluation of Peyronie’s Disease
 History, Physical Exam, Appropriate Laboratory tests as indicated.
 Peyronie’s Symptom Questionnaire; IIEF
 Intracorporeal injection to produce an artificial erection with measurement
of the curvature, plaque size, penile length.

Side Effects and Risks of Xiaflex
 Penile hematoma (bruising, mostly minor; small number of men develop
significant hematoma): 66%
 Severe penile hematoma: 6%
 Penile Swelling: 55%
 Injection site Penile Pain: 45%
 Painful erection: 3%
 “Popping sounds or cracking sounds”: 13%
 Corporal rupture: 0.5% (most occurred within 2 weeks after
injection; for this reason no sex is allowed for 2 weeks after
injections).

Treatment Schedule Cycle 1; then every 8 weeks
 Day 1 Cycle 1: One Injection of Xiaflex 0.58 mg into the plaque that causes
curvature (Injection #1)
 Day 2-4 Cycle 1: One Injection of Xiaflex 0.58 mg into the plaque that causes
curvature (Injection #2)
 Day 6-8 Cycle 1: Penile remodeling by the urologist – the patient will be taught how
to perform it at home
 Weeks 2-7: Patient does penile remodeling by himself three times daily at home. No
office visits necessary unless questions or problems arise.
 If the curvature becomes <15 degrees, no further treatment with Xiaflex is needed.
Repeat every 8 weeks up to 4 cycles maximum.

Xiaflex: Results from Clinical Trials
Martin Gelbard, Irwin Goldstein et al. Clinical Efficacy, Safety and Tolerability of Collagenase Clostridium Histolyticum for the Treatment of Peyronie
Disease in 2 Large Double-Blind, Randomized, Placebo Controlled Phase 3 Studies J Urology Volume 190, Issue 1, Pages 199–207, July 2013
Table 2Co-primary and secondary clinical outcomes at week 52 (last observation carried
forward) in CCh vs placebo treated subjects
IMPRESS I + II Combined Analysis
CCh Placebo
No. subjects 401 211
Co-primary
Mean ± SD penile
curvature/median (range):
Baseline (degrees) 50.1 ± 14.4/48.0 (30–90) 49.3 ± 14.0/46.0 (30–89)
Wk 52 (degrees) 33.1 ± 16.8/32.0 (0–82) 40.0 ± 16.2/40.0 (0–80)
% Change −34.0/−34.8 (−100−63) −18.2/−18.2 (−100−94)
p Value <0.0001 —
 30% Curvature Change vs Placebo

Xiaflex – Pain : Results from Clinical Trials
Martin Gelbard, Irwin Goldstein et al. Clinical Efficacy, Safety and Tolerability of Collagenase Clostridium Histolyticum for the Treatment of Peyronie
Disease in 2 Large Double-Blind, Randomized, Placebo Controlled Phase 3 Studies J Urology Volume 190, Issue 1, Pages 199–207, July 2013
 No Significant Pain Change vs Placebo (Combined Trials)
Table 2 Co-primary and secondary clinical outcomes at week 52 (last
observation carried forward) in CCh vs placebo treated subjects
IMPRESS I + II Combined Analysis
CCh Placebo
No. subjects 401 211
Mean ± SD PDQ
penile pain:
Baseline 8.8 ± 4.6 8.9 ± 4.9
Wk 52 4.4 ± 4.9 4.6 ± 5.6
Change −4.4 ± 5.6 −4.3 ± 4.8
p Value 0.9672 —

Questions about Xiaflex Treatment for Peyronie’s Disease?
Alex Shteynshlyuger MD
info@NewYorkUrologySpecialists.com

Xiaflex for Treatment of Peyronie's Disease Curvature (Curved or Bent Penis)

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