Low Energy Shockwave Therapy for Improving Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the change from baseline in the erectile
      function domain of the International Index of Erectile Function (IIEF-EF) scores in patients
      receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment.
      The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.
    

Detailed description: 
      The secondary objectives of this study are:

      A. To evaluate erectile function (EF) categorical improvement in patients receiving 4 weekly
      treatments of shockwave therapy versus those receiving a sham treatment, at 3 months after a
      first sequence of treatment.

      B. To compare improvements in erectile function between 4 weeks of phosphodiesterase type 5
      inhibitor (PDE5i) use and 4 weekly treatments of shockwave therapy ("within patient" effect).

      C. To compare improvements in erectile function between 4 weeks of PDE5 inhibitor use and 4
      weekly treatments of sham shock wave therapy ("within patient" effect).

      D. To evaluate the effect of a 2nd sequence of 4-8 weekly shock wave treatments 3 months
      after this second sequence.

      E. To evaluate treatment effects (the same comparisons as in objectives A, B, C, D) on other
      validated measure of EF (question 2 of the sexual encounter profile (SEP2), question 3 of the
      sexual encounter profile (SEP3), Global Assessment Question (GAQ), Erection Hardness Scale
      (EHS)), and the remaining domains of the IIEF score (orgasmic function, sexual desire,
      intercourse satisfaction, overall satisfaction), as well as the total IIEF score.

      F. To evaluate treatment tolerance and potential adverse events. G. To compare changes in EF
      measures over time for a follow-up period of 12 months following the second sequence of 4
      weekly shock wave treatments.

      H. To compare the effect of a sequence of 4 weekly shock wave treatments versus 8 biweekly
      shock wave treatments 3 months after the treatment ("within patient" effect).
    

Intervention name(s): Pre-inclusion questionnaires; 1 month of PDE5i treatment; PDE5i follow-up questionnaires; Inclusion questionnaires; 4 weekly LIESWT (Wave 1) with the RENOVA device; 4 weekly sham LIESWT (Wave 1) with the RENOVA device; Follow-up questionnaires 1 month after Wave 1; Follow-up questionnaires 3 months after Wave 1; 8 bi-weekly LIESWT (Wave 2) with the RENOVA device; Follow-up questionnaires 1 month after Wave 2; Questionnaires via postal mail; Final follow-up questionnaires 12 months after Wave 2
Intervention type(s): Other; Drug; Other; Other; Device; Device; Other; Other; Device; Other; Other; Other
Intervention description(s): (Month -2)
During this visit, the investigator will:
Validate the patient's inclusion and exclusion criteria;
Obtain informed consent from the patient;
Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
Prescribe 1 month of PDE5i treatment.
The next visit will be scheduled; 5 mg Tadalafil per day for 1 month; (Month -1)
During this visit the investigator will:
Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
Remind the patient that over the next 4 weeks he is not to take any treatments for his condition (wash-out period).
The next visit will be scheduled; (Day 0)
During this visit the investigator will:
Verify inclusion and exclusion criteria, and proceed with final inclusion
Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
Randomize the patient at the end of the visit
The patient will go home with a calendar specifying the time and place of the various visits. The patient should have four weekly LIESWT or sham sessions within the next month. The first session may take place the same day and immediately after the present visit.; Following final inclusion, patients will have weekly LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.; Following final inclusion, patients will have weekly sham LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.; (Month 2)
During this visit the investigator will:
Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
Perform a clinical exam; particular attention is given to the recording of complications / adverse events.; (Month 4)
During this visit the investigator will:
Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
The patient should have four weekly LIESWT sessions within the next month. The first session may take place the same day and immediately after the present visit.; During the 5th month following final inclusion, all patients will have bi-weekly LIESWT sessions. These will occur twice per week for four consecutive weeks. Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.; (Month 6)
During this visit the investigator will:
Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
Perform a clinical exam; particular attention is given to the recording of complications / adverse events.; Eight, 11, and 14 months after final inclusion, corresponding to 3, 6 and 9 months following Wave 2, the IIEF, SEP2, SEP3, GAQ and EHS questionnaires will be sent to patients via postal mail.; (Month 17)
During this visit the investigator will:
Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment