Erectile Dysfunction Following Radical ProstatectomyLiST-PRPNCT03862599
Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
A study testing Extra-corporeal shockwave therapy (ESWT) in people with Erectile Dysfunction Following Radical Prostatectomy, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Extra-corporeal shockwave therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- No pre-operative urinary incontinence (no usage of urinary pads)
- Sexually active
- Able to understand and complete patient questionnaires
- Consent to participate
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Trust
London
Findlay MacAskill, MRCS, 07926073398
About this study
Official title: 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.
Read the 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.
- Being tested
- Extra-corporeal shockwave therapy (ESWT), Standard care
- Keywords
- erectile dysfunction, shockwave, treatment, prostatectomy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-corporeal shockwave therapy (ESWT)Device
low-intensity extra-corporeal shockwave therapy
Standard careOther
Cialis and vacuum pump
| Study group | Role | What they receive |
|---|---|---|
| Standard care + sham ESWT | Sham comparator | Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT) Receives: Device: Extra-corporeal shockwave therapy (ESWT); Other: Standard care |
| Standard care + active ESWT | Active comparator | Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT) Receives: Device: Extra-corporeal shockwave therapy (ESWT); Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Penile length
Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months
Measured: 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
Measured: 12 months
Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jun 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tet Yap, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Tet Yap, FRCS (Urol), Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862599
- Sponsor's protocol ID
- 250004
- Acronym
- LiST-PRP
- Status last verified
- Mar 2023
- First submitted
- 10 Oct 2018
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29396020
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03862599
- Acronym / sponsor ID
- LiST-PRP / 250004
- Keywords
- erectile dysfunction, shockwave, treatment, prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard care + sham ESWT | Sham comparator | Device: Extra-corporeal shockwave therapy (ESWT), Other: Standard careCialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT) |
| Standard care + active ESWT | Active comparator | Device: Extra-corporeal shockwave therapy (ESWT), Other: Standard careCialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 40 - 65
- Diagnosed with low/intermediate-risk prostate cancer:
- PSA < 20 ng/ml
- Gleason score < 8
- PCa stage =< T2b
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-corporeal shockwave therapy (ESWT)low-intensity extra-corporeal shockwave therapy | Device | Standard care + active ESWT, Standard care + sham ESWT |
| Standard careCialis and vacuum pump | Other | Standard care + active ESWT, Standard care + sham ESWT |
Primary outcome
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
3 secondary outcomes
Penile length
Time frame: 12 months
Urinary Incontinence
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 29396020Kalyvianakis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tet Yap, FRCS (Urol) principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-corporeal shockwave therapy (ESWT) in people with Erectile Dysfunction Following Radical Prostatectomy, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tet Yap, FRCS (Urol) (07748182772, tet.yap@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.