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Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy (LiST-PRP)

Primary Purpose

Erectile Dysfunction Following Radical Prostatectomy

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Extra-corporeal shockwave therapy (ESWT)
Standard care
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction Following Radical Prostatectomy focused on measuring erectile dysfunction, shockwave, treatment, prostatectomy

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 40 - 65
  • Diagnosed with low/intermediate-risk prostate cancer:
  • PSA < 20 ng/ml
  • Gleason score < 8
  • PCa stage =< T2b
  • Baseline IIEF-ED 17-30 without erectogenic aids
  • No pre-operative urinary incontinence (no usage of urinary pads)
  • Sexually active
  • Able to understand and complete patient questionnaires
  • Consent to participate

Exclusion Criteria:

  • Anatomical abnormalities in the genitalia or pelvic region
  • Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak)
  • Incomplete tumor removal (positive surgical margin)
  • Tumor upstaging beyond T2b
  • Nerve sparing score > 5
  • Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
  • Untreated hypogonadism (serum total testosterone < 300 mg/dL)
  • Anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily
  • Any other condition that would prevent the patient from completing the study, as judged by the principle investigator

Sites / Locations

  • Guy's and St Thomas' NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Standard care + sham ESWT

Standard care + active ESWT

Arm Description

Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)

Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)

Outcomes

Primary Outcome Measures

Sexual Function
Measurement of average change in IIEF-ED from baseline (pre-RP) to 24 week-FU 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome

Secondary Outcome Measures

Penile length
Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months
Urinary Incontinence
Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months
Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Full Information

First Posted
October 10, 2018
Last Updated
March 6, 2023
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03862599
Brief Title
Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
Acronym
LiST-PRP
Official Title
Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. A few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery.
Detailed Description
Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. At present, this debilitating consequence of surgery is managed in a step-wise approach including oral medication, injections and in severe cases, insertion of a penile prosthesis. A few small studies have shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery. Low-intensity shockwave therapy would be a non-invasive treatment to preserve and improve patient's sexual function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction Following Radical Prostatectomy
Keywords
erectile dysfunction, shockwave, treatment, prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking of probe applicator at device manufacturer before ESWT use
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care + sham ESWT
Arm Type
Sham Comparator
Arm Description
Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
Arm Title
Standard care + active ESWT
Arm Type
Active Comparator
Arm Description
Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)
Intervention Type
Device
Intervention Name(s)
Extra-corporeal shockwave therapy (ESWT)
Intervention Description
low-intensity extra-corporeal shockwave therapy
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Cialis and vacuum pump
Primary Outcome Measure Information:
Title
Sexual Function
Description
Measurement of average change in IIEF-ED from baseline (pre-RP) to 24 week-FU 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Penile length
Description
Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months
Time Frame
12 months
Title
Urinary Incontinence
Description
Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months
Time Frame
12 months
Title
Adverse Events
Description
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40 - 65 Diagnosed with low/intermediate-risk prostate cancer: PSA < 20 ng/ml Gleason score < 8 PCa stage =< T2b Baseline IIEF-ED 17-30 without erectogenic aids No pre-operative urinary incontinence (no usage of urinary pads) Sexually active Able to understand and complete patient questionnaires Consent to participate Exclusion Criteria: Anatomical abnormalities in the genitalia or pelvic region Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak) Incomplete tumor removal (positive surgical margin) Tumor upstaging beyond T2b Nerve sparing score > 5 Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy Untreated hypogonadism (serum total testosterone < 300 mg/dL) Anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily Any other condition that would prevent the patient from completing the study, as judged by the principle investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tet Yap, FRCS (Urol)
Phone
07748182772
Email
tet.yap@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Findlay MacAskill, MRCS
Phone
07748182772
Email
findlay.macaskill@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tet Yap, FRCS (Urol)
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Findlay MacAskill, MRCS
Phone
07926073398

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29396020
Citation
Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1.
Results Reference
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Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy

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