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Completed

NCT Number: NCT01272297

The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders

Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ED of more than 6 months
  • Rigidity score ≤ 2 during PDE5i therapy
  • Stable heterosexual relationship for more than 3 months
  • Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .

Exclusion criteria

  • Prior surgery or radiotherapy in pelvic region
  • Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Anti-androgens, oral or injectable androgens
  • Cardiovascular conditions that prevent sexual activity

Treatment and study plan

LI-ESWT

Device

Low intensity shock wave treatment - 12 sessions

Other names: Omnispec model ED1000

Primary outcomes

  1. IIEF-ED Domain score

    Time frame: 17 weeks after first visit

    Change of 5 points and above in IIEF-ED Domain score

Secondary outcomes

  1. rigidity scale

    Time frame: 17 weeks from visit 1

    a change to 3 or 4 points in the rigidty scale

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Medispec

Registry information

Official study title

The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication

Acronym: LI-ESWT

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2011
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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