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Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study (ProstaChoc 1)

Primary Purpose

Erectile Dysfunction

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
8 bi-weekly LIESWT sessions
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The study population

Arm Description

The study population is comprised of adult men less than 80 years of age who are consulting for ED lasting for over 6 months following a prostatectomy that took place 18 to 60 months ago. The patients are currently in a stable relationship that has been going on for at least 3 months, have an IIEF-EF score between 6 and 25, and have at least a natural tumescence during sexual stimulation (EHS score ≥ 1). Intervention: 8 bi-weekly LIESWT sessions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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).
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).
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)
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)
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)
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)
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)
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)
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)
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)
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)
The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)
The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)
Visual analog scale for pain during treatment (score from 0 to 10)
Visual analog scale for pain during treatment (score from 0 to 10)
Visual analog scale for pain during treatment (score from 0 to 10)
Visual analog scale for pain during treatment (score from 0 to 10)
Visual analog scale for pain during treatment (score from 0 to 10)
Visual analog scale for pain during treatment (score from 0 to 10)
Visual analog scale for pain during treatment (score from 0 to 10)
Visual analog scale for pain during treatment (score from 0 to 10)
The presence/absence any other complications that might occur (almost none are cited in the literature)

Full Information

First Posted
April 13, 2016
Last Updated
June 16, 2017
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Direx Systems GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02746094
Brief Title
Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study
Acronym
ProstaChoc 1
Official Title
Low Frequency Shock Wave Therapy for Improving Post-prostatectomy Erectile Dysfunction: a Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Change strategy
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Direx Systems GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The study population
Arm Type
Experimental
Arm Description
The study population is comprised of adult men less than 80 years of age who are consulting for ED lasting for over 6 months following a prostatectomy that took place 18 to 60 months ago. The patients are currently in a stable relationship that has been going on for at least 3 months, have an IIEF-EF score between 6 and 25, and have at least a natural tumescence during sexual stimulation (EHS score ≥ 1). Intervention: 8 bi-weekly LIESWT sessions
Intervention Type
Device
Intervention Name(s)
8 bi-weekly LIESWT sessions
Other Intervention Name(s)
RENOVA device
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference in the rate of change for the IIEF-EF score before and after treatment sessions (change per two-month period).
Description
IIEF-EF = the erectile function domain of the International Index of Erectile Function
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
-8 to 0 weeks versus 0 to 8 weeks
Title
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.
Description
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).
Time Frame
-8 to 0 weeks versus 0 to 16 weeks
Title
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.
Description
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).
Time Frame
0 to 8 weeks versus 8 to 16 weeks
Title
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.
Description
Were you able to insert your penis into your partner's vagina? (yes/no)
Time Frame
-8 to 0 weeks versus 0 to 8 weeks
Title
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.
Description
Were you able to insert your penis into your partner's vagina? (yes/no)
Time Frame
-8 to 0 weeks versus 0 to 16 weeks
Title
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.
Description
Were you able to insert your penis into your partner's vagina? (yes/no)
Time Frame
0 to 8 weeks versus 8 to 16 weeks
Title
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.
Description
Did your erection last long enough for you to have successful intercourse? (yes/no)
Time Frame
-8 to 0 weeks versus 0 to 8 weeks
Title
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.
Description
Did your erection last long enough for you to have successful intercourse? (yes/no)
Time Frame
-8 to 0 weeks versus 0 to 16 weeks
Title
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.
Description
Did your erection last long enough for you to have successful intercourse? (yes/no)
Time Frame
0 to 8 weeks versus 8 to 16 weeks
Title
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.
Description
Has the treatment you have been taking improved your erectile function? (yes/no)
Time Frame
-8 to 0 weeks versus 0 to 8 weeks
Title
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.
Description
Has the treatment you have been taking improved your erectile function? (yes/no)
Time Frame
-8 to 0 weeks versus 0 to 16 weeks
Title
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.
Description
Has the treatment you have been taking improved your erectile function? (yes/no)
Time Frame
0 to 8 weeks versus 8 to 16 weeks
Title
The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Title
The difference in the rate of change for the total IIEF score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Title
The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Title
The difference in the rate of change for the IIEF erectile function subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Title
The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Title
The difference in the rate of change for the IIEF sexual satisfaction subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Title
The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Title
The difference in the rate of change for the IIEF orgasmic function subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Title
The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Title
The difference in the rate of change for the IIEF sexual desire subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Title
The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Title
The difference in the rate of change for the IIEF overall satisfaction subdomain score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Title
The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 8 weeks
Title
The difference in the rate of change for the EHS Score before and after treatment sessions (change per two-month period)
Time Frame
rate of change between -8 and 0 weeks versus rate of change between 0 and 16 weeks
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 1, Monday or Tuesday
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 1, Thursday or Friday
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 2, Monday or Tuesday
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 2, Thursday or Friday
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 3, Monday or Tuesday
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 3, Thursday or Friday
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 4, Monday or Tuesday
Title
Visual analog scale for pain during treatment (score from 0 to 10)
Time Frame
Week 4, Thursday or Friday
Title
The presence/absence any other complications that might occur (almost none are cited in the literature)
Time Frame
Week 16

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Droupy, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21855209
Citation
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.
Results Reference
background

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

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