Low Energy Shockwave Therapy for Improving Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— Shock-ED  

Official title:

The Effectiveness of Low Energy Shockwave Therapy for Improving Erectile Dysfunction in Men: a Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304679
• Other study ID #: PHRC-N/2013/SD-01
• Secondary ID: 2014-A00486-41
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: June 22, 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 22, 2020
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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)

Exclusion criteria: The patient has contraindications for Cialis as mentioned in the SPC, re-given here :

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC.

• In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated. (see section 4.5 of the SPC).

• CIALIS, must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

• The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated:

• patients with myocardial infarction within the last 90 days,

• patients with unstable angina or angina occurring during sexual intercourse,

• patients with New York Heart Association Class 2 or greater heart failure in the last 6 months,

• patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled

• uncontrolled hypertension,

• patients with a stroke within the last 6 months.

• CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4 of the SPC).

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• Pre-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

Drug:
• 1 month of PDE5i treatment
5 mg Tadalafil per day for 1 month

Other:
• PDE5i 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
• Inclusion questionnaires
(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.

Device:
• 4 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.
• 4 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.

Other:
• Follow-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.
• Follow-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.

Device:
• 8 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.

Other:
• Follow-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.
• Questionnaires 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.
• Final 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.

Locations

Country	Name	City	State
France	CHU de Bordeax - Hôpital Pellegrin	Bordeaux
France	APHP - Hôpital Raymond-Poincaré	Garches
France	Clinique Beau Soleil	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	CHU de Lyon - Centre Hospitalier Lyon Sud	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IIEF-EF score		Month 0 versus Month 4
Secondary	% patients with improvement	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)	Month 0 versus Month 4
Secondary	% patients with improvement	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)	Month -2 versus Month -1
Secondary	% patients with improvement	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)	Month 0 versus Month 2
Secondary	% patients with improvement	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)	Month 0 versus Month 8
Secondary	% patients with improvement	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)	Month 4 versus Month 8
Secondary	Change in IIEF-EF score		Change between month -2 and month -1
Secondary	Change in IIEF-EF score from baseline		Change between month 0 and month 2
Secondary	Change in IIEF-EF score from baseline		Change between month 0 and month 8
Secondary	Change in IIEF-EF score from baseline		Change between month 4 and month 8
Secondary	% patients answering "yes" to the SEP2		Month 0 versus month 4
Secondary	% patients answering "yes" to the SEP2		Month -2 versus month -1
Secondary	% patients answering "yes" to the SEP2		Month 0 versus month 2
Secondary	% patients answering "yes" to the SEP2		Month 0 versus month 8
Secondary	% patients answering "yes" to the SEP2		Month 0 versus month 6
Secondary	% patients answering "yes" to the SEP2		Month 0 versus month 11
Secondary	% patients answering "yes" to the SEP2		Month 0 versus month 14
Secondary	% patients answering "yes" to the SEP2		Month 0 versus month 17
Secondary	% patients answering "yes" to the SEP3		Month 0 versus month 4
Secondary	% patients answering "yes" to the SEP3		Month -2 versus month -1
Secondary	% patients answering "yes" to the SEP3		Month 0 versus month 2
Secondary	% patients answering "yes" to the SEP3		Month 0 versus month 8
Secondary	% patients answering "yes" to the SEP3		Month 0 versus month 6
Secondary	% patients answering "yes" to the SEP3		Month 0 versus month 11
Secondary	% patients answering "yes" to the SEP3		Month 0 versus month 14
Secondary	% patients answering "yes" to the SEP3		Month 0 versus month 17
Secondary	% patients answering "yes" to the GAQ		Month 0 versus month 4
Secondary	% patients answering "yes" to the GAQ		Month -2 versus month -1
Secondary	% patients answering "yes" to the GAQ		Month 0 versus month 2
Secondary	% patients answering "yes" to the GAQ		Month 0 versus month 8
Secondary	% patients answering "yes" to the GAQ		Month 0 versus month 6
Secondary	% patients answering "yes" to the GAQ		Month 0 versus month 11
Secondary	% patients answering "yes" to the GAQ		Month 0 versus month 14
Secondary	% patients answering "yes" to the GAQ		Month 0 versus month 17
Secondary	Change in EHS		Month 0 versus month 4
Secondary	Change in EHS		Month -2 versus month -1
Secondary	Change in EHS		Month 0 versus month 2
Secondary	Change in EHS		Month 0 versus month 8
Secondary	Change in EHS		Month 0 versus month 6
Secondary	Change in EHS		Month 0 versus month 11
Secondary	Change in EHS		Month 0 versus month 14
Secondary	Change in EHS		Month 0 versus month 17
Secondary	Change in IIEF score (including subscores)		Month 0 versus month 4
Secondary	Change in IIEF score (including subscores)		Month -2 versus month -1
Secondary	Change in IIEF score (including subscores)		Month 0 versus month 2
Secondary	Change in IIEF score (including subscores)		Month 0 versus month 8
Secondary	Change in IIEF score (including subscores)		Month 0 versus month 6
Secondary	Change in IIEF score (including subscores)		Month 0 versus month 11
Secondary	Change in IIEF score (including subscores)		Month 0 versus month 14
Secondary	Change in IIEF score (including subscores)		Month 0 versus month 17
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Week 1
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Week 2
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Week 3
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Week 4
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Month 5, week 1
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Month 5, week 2
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Month 5, week 3
Secondary	Visual analog scale for pain during treatment	Immediately after treatment session.	Month 5, week 4
Secondary	The number of patients with other complications	Any other complications that might occur throughout the study (very few are listed in the literature).	Month 17