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

March 6, 2023 updated by: Tet Yap, Guy's and St Thomas' NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Trust
        • Contact:
          • Findlay MacAskill, MRCS
          • Phone Number: 07926073398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penile length
Time Frame: 12 months
Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months
12 months
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
12 months
Adverse Events
Time Frame: 12 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Tet Yap, FRCS (Urol), Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

March 2, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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