Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study

Erectile Dysfunction Clinical Trial

— ProstaChoc 1  

Official title:

Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02746094
• Other study ID #: LOCAL/2016/SD-01
• Status: Withdrawn
• Phase: N/A
• First received: April 13, 2016
• Last updated: June 16, 2017
• Start date: April 2017
• Est. completion date: April 2019

Study information

• Verified date: June 2017
• 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 changes in erectile function (EF) before versus after 8 bi-weekly treatments of Low-Intensity Extracorporeal Shock Wave Therapy (LIESWT) via IIEF-EF (the Erectile Function domain of the International Index of Erectile Function) scores.

Description:

The secondary objectives of this study are to evaluate changes in the following elements before versus after 8 bi-weekly treatments of LIESWT:

A. EF categorical improvement.

B. Other validated measures of EF (SEP2 (question 2 of the sexual encounter profile), SEP3 (question 3 of the sexual encounter profile), GAQ (Global Assessment Question), EHS (Erection Hardness Score)), and the remaining domains of the IIEF score (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction), as well as the total IIEF score.

C. Harms/Safety: To evaluate treatment tolerance and potential adverse events.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• The patient has given his informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

• The patient is a man at least 18 years old and less than 80 years old

• The patient has been in a stable, sexual relationship with only one other person for at least the past three months

• The patient is consulting for erectile dysfunction lasting for over 6 months

• The patient had a prostatectomy 18 to 60 months ago

• The patient has an erectile function domain score on the International Index of Erectile Function questionnaire between 6 and 25

• The patient has at least a natural tumescence during sexual stimulation (erection hardness score = 1)

• The patient has not had phosphodiesterase type 5 inhibitor treatment for the month preceding inclusion

• The patient is available for 8 months of follow-up and agrees to participate in all study visits

Exclusion Criteria:

• The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, or is an adult under guardianship

• It is impossible to correctly inform the patient, or the patient refuses to sign the consent

• Complete anerection

• Untreated testosterone deficiency

• Neurological disease

• Psychiatric disease

• Anatomical malformation of the penis

• Chronic haematological pathology with significant clinical impact

• Oral or injectable antiandrogen treatment

• The patient is taking blood thinners and has an international normalized ratio > 3

• History of erectile dysfunction before the prostatectomy

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• 8 bi-weekly LIESWT sessions
LIESWT = Low-Intensity Extracorporeal Shock Wave Therapy The treatment protocol consists of eight bi-weekly treatment sessions (weeks 0 ot 4). During each session 3600 shocks at 0.09 mJ/mm are applied. Shocks are applied to the penis shaft at the right corpus cavernosum and the left corpus cavernosum, and at the crura at the right crus and the left crus. 900 shocks are administered to each area. The treatment areas are the same for each session, so that at the end of the full treatment (8 sessions) each area will have received 7200 shocks at 0.09 mJ/mm. In general, the patient is placed on an examination table. A series of focused shockwaves produced by the electromagnetic transducer are coupled to a patient's penile shaft and crura and are made to converge along the penis/crura volume. The operator controls treatment parameters including shockwave intensity and shockwave rate. mJ = millijoule.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Direx Systems GmbH

Country where clinical trial is conducted

France, 

References & Publications (1)

Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the rate of change for the IIEF-EF score before and after treatment sessions (change per two-month period).	IIEF-EF = the erectile function domain of the International Index of Erectile Function	rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The change in the number of patients with improvement in erectile function (EF) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Improvement in EF is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction (ED), >5 points for moderate ED and >7 points for severe ED (Rosen et al. 2011).	-8 to 0 weeks versus 0 to 8 weeks
Secondary	The change in the number of patients with improvement in erectile function (EF) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Improvement in EF is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction (ED), >5 points for moderate ED and >7 points for severe ED (Rosen et al. 2011).	-8 to 0 weeks versus 0 to 16 weeks
Secondary	The change in the number of patients with improvement in erectile function (EF) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Improvement in EF is defined as a >2 point increase in the IIEF-EF score from baseline for mild erectile dysfunction (ED), >5 points for moderate ED and >7 points for severe ED (Rosen et al. 2011).	0 to 8 weeks versus 8 to 16 weeks
Secondary	The change in the number of patients responding yes to question 2 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Were you able to insert your penis into your partner's vagina? (yes/no)	-8 to 0 weeks versus 0 to 8 weeks
Secondary	The change in the number of patients responding yes to question 2 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Were you able to insert your penis into your partner's vagina? (yes/no)	-8 to 0 weeks versus 0 to 16 weeks
Secondary	The change in the number of patients responding yes to question 2 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Were you able to insert your penis into your partner's vagina? (yes/no)	0 to 8 weeks versus 8 to 16 weeks
Secondary	The change in the number of patients responding yes to question 3 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Did your erection last long enough for you to have successful intercourse? (yes/no)	-8 to 0 weeks versus 0 to 8 weeks
Secondary	The change in the number of patients responding yes to question 3 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Did your erection last long enough for you to have successful intercourse? (yes/no)	-8 to 0 weeks versus 0 to 16 weeks
Secondary	The change in the number of patients responding yes to question 3 of the Sexual Encounter Profile over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Did your erection last long enough for you to have successful intercourse? (yes/no)	0 to 8 weeks versus 8 to 16 weeks
Secondary	The change in the number of patients responding yes to the Global Assessment Question (yes/no) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Has the treatment you have been taking improved your erectile function? (yes/no)	-8 to 0 weeks versus 0 to 8 weeks
Secondary	The change in the number of patients responding yes to the Global Assessment Question (yes/no) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Has the treatment you have been taking improved your erectile function? (yes/no)	-8 to 0 weeks versus 0 to 16 weeks
Secondary	The change in the number of patients responding yes to the Global Assessment Question (yes/no) over a period of observation before the treatment sessions versus a period of observation after the start of treatment sessions.	Has the treatment you have been taking improved your erectile function? (yes/no)	0 to 8 weeks versus 8 to 16 weeks
Secondary	The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Secondary	The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Secondary	The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Secondary	The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Secondary	The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Secondary	The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Secondary	The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary	The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)		rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 1, Monday or Tuesday
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 1, Thursday or Friday
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 2, Monday or Tuesday
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 2, Thursday or Friday
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 3, Monday or Tuesday
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 3, Thursday or Friday
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 4, Monday or Tuesday
Secondary	Visual analog scale for pain during treatment (score from 0 to 10)		Week 4, Thursday or Friday
Secondary	The presence/absence any other complications that might occur (almost none are cited in the literature)		Week 16