Erectile Dysfunction
Conditions
Brief 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).
Interventions
DEVICE4 weekly sham LIESWT (Wave 1) with the RENOVA device
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.
OTHERPre-inclusion questionnaires
(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
DRUG1 month of PDE5i treatment
5 mg Tadalafil per day for 1 month
OTHERPDE5i follow-up questionnaires
(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.
DEVICE4 weekly LIESWT (Wave 1) with the RENOVA device
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.
OTHERFollow-up questionnaires 1 month after Wave 1
(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.
OTHERFollow-up questionnaires 3 months after Wave 1
(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.
DEVICE8 bi-weekly LIESWT (Wave 2) with the RENOVA device
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.
OTHERFollow-up questionnaires 1 month after Wave 2
(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.
OTHERQuestionnaires via postal mail
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.
OTHERFinal follow-up questionnaires 12 months after Wave 2
(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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* The patient has been correctly informed about the study. * The patient must have given his informed and signed consent. * The patient must be insured or beneficiary of a health insurance plan. * The patient is a man between 18 and 80 years of age. (≥18 years and \< 80 years) * The patient has been in a stable sexual relationship for over 3 months * The patient is consulting for erectile dysfunction lasting for over 6 months * IIEF-EF6 score between 6 and 25 * Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1) * Pre-inclusion: Patient is willing to have 4 weeks of PDE5i treatment at the beginning of the trial, and then stop all treatment for an additional month. * Pre-inclusion: The patient agrees to try to engage at least 3 sexual intercourses per month during this period * Inclusion: Patient has completed 4 weeks of PDE5i treatment, and then stopped all treatment for an additional month. * Patient is available for a follow up of 19 months (at time of pre-inclusion and then 17 months at time of inclusion)
Exclusion criteria
* The patient is participating in another interventional study * Within the past three months, the patient has participated in another interventional study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection * The patient is an adult under guardianship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Complete anerection * History of pelvic cancer surgery (radical prostatectomy, cystectomy, abdominoperineal resection of the rectum) * Untreated testosterone deficiency * Neurological disease affecting the central nervous system * Untreated psychiatric disease, or psychiatric disease that may compromise study participation * Anatomical malformation of the penis considered by the investigator as being able to prevent vaginal penetration * Chronic haematological pathology associated with risk of haemorrhage * Oral or injectable antiandrogen treatment * The patient is taking blood thinners AND/OR has an International Normalized Ratio \>3 * Known allergy to treatments used in the study (e.g. Cialis, gel)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IIEF-EF score | Month 0 versus Month 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IIEF-EF score | Change between month -2 and month -1 | — |
| Change in IIEF-EF score from baseline | Change between month 0 and month 2 | — |
| % patients answering yes to the SEP2 | Month 0 versus month 4 | — |
| % patients answering yes to the SEP3 | Month 0 versus month 4 | — |
| % patients with improvement | Month 0 versus Month 4 | The presence/absence of improvement in erectile function as compared to baseline. Improvement in erectile function is defined as a \>2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction, \>5 points for moderate erectile dysfunction and \>7 points for severe erectile dysfunction(Rosen et al. 2011) |
| Change in EHS | Month 0 versus month 4 | — |
| Change in IIEF score (including subscores) | Month 0 versus month 4 | — |
| Visual analog scale for pain during treatment | Week 1 | Immediately after treatment session. |
| The number of patients with other complications | Month 17 | Any other complications that might occur throughout the study (very few are listed in the literature). |
| % patients answering yes to the GAQ | Month 0 versus month 4 | — |
Countries
France
Outcome results
None listed