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

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ClinicalTrials.gov Identifier: NCT03862599
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
Tet Yap, Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Following Radical Prostatectomy Device: Extra-corporeal shockwave therapy (ESWT) Other: Standard care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking of probe applicator at device manufacturer before ESWT use
Primary Purpose: Treatment
Official Title: Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Standard care + sham ESWT
Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
Device: Extra-corporeal shockwave therapy (ESWT)
low-intensity extra-corporeal shockwave therapy

Other: Standard care
Cialis and vacuum pump

Active Comparator: Standard care + active ESWT
Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)
Device: Extra-corporeal shockwave therapy (ESWT)
low-intensity extra-corporeal shockwave therapy

Other: Standard care
Cialis and vacuum pump




Primary Outcome Measures :
  1. Sexual Function [ Time Frame: 6 months ]
    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 :
  1. Penile length [ Time Frame: 12 months ]
    Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months

  2. Urinary Incontinence [ Time Frame: 12 months ]
    Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months

  3. Adverse Events [ Time Frame: 12 months ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862599


Contacts
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Contact: Tet Yap, FRCS (Urol) 07748182772 tet.yap@gstt.nhs.uk
Contact: Findlay MacAskill, MRCS 07748182772 findlay.macaskill@gstt.nhs.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Trust Recruiting
London, United Kingdom
Contact: Findlay MacAskill, MRCS    07926073398      
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Tet Yap, FRCS (Urol) Guy's and St Thomas' NHS Foundation Trust
Publications:
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Responsible Party: Tet Yap, Principal Investigator, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03862599    
Other Study ID Numbers: 250004
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Tet Yap, Guy's and St Thomas' NHS Foundation Trust:
erectile dysfunction
shockwave
treatment
prostatectomy
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders