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Erectile DysfunctionNCT05877144

LiSWT for Nerve Sparing Radical Prostatectomy ED

A study testing Nerve-Sparing Prostatectomy, Medical Device Usage and Evaluation and Duplex Ultrasound in people with Erectile Dysfunction and Localized Prostate Carcinoma, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
Nerve-Sparing Prostatectomy, Medical Device Usage and Evaluation and Duplex Ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteUnited States
Study dates
6 Jul 2023to 30 Jan 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 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Men aged 18-80 diagnosed with localized prostate cancer
  • Score 12 or higher on the pre-operative International Index of Erectile Function (IIEF) assessment
  • Undergo the nerve-sparing radical prostatectomy procedure
  • Be taking PDE5i medication for the entirety of the study (normal course of care)
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  • Be in a sexual relationship with a partner for at least 3 months
  • Be willing to attempt sexual activity during the screening period and before each follow-up visit
  • Be willing to stop all erectile aids (e.g. prescription and non-prescription erectile medications not part of this study, penile injections, vacuum erection devices, constriction rings) during the screening and study period

Who cannot join

  • • Subject does not speak or understand English
  • Subject has been treated with acoustic wave previously
  • Subject has had prior penile surgery
  • Patients with pacemakers or implantable defibrillators
  • Patients who are using devices which are sensitive to electromagnetic radiation
  • Patients who are found to have metastatic disease and require radiation/hormone therapy before initiation of shockwave/sham treatments
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  • Subject has lesions or active infections on the penis or perineum
  • Subject is unwilling to remove piercings from the genital region
  • Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week
  • Subject has received an investigational drug within 30 days prior to signing consent
  • Subject has received platelet-rich plasma (PRP) within 3 months of signing consent
  • Subject has received stem cell within 6 months of signing consent
  • Subject has any condition or exhibits behavior that indicates to the principle investigator (PI) that the subject is unlikely to be compliant with study procedures and visits
  • Cognitively/decisionally-impaired individuals

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy

This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Erectile dysfunction (ED) is a known side effect of the radical prostatectomy procedure. The low intensity shockwave therapy delivers painless electrotherapy pulse to increase blood flow and supply, activation of tissues and wound healing. Using LiSWT after NS-PRP may improve erectile function in men with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine whether LiSWT following nerve-sparing radical prostatectomy (NS-RP) improves outcomes in men with erectile dysfunction (ED) supported by cGMP phosphodiesterase inhibitor (PDE5i) medication.

SECONDARY OBJECTIVES:

  1. To determine whether LiSWT improves duplex doppler ultrasound (DDUS) flow parameters at 6 months following LiSWT treatment.

II. To determine the postoperative durability of any beneficial outcome of LiWST treatment to erectile function.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

ARM II: Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

Being tested
Nerve-Sparing Prostatectomy, Medical Device Usage and Evaluation, Duplex Ultrasound, Survey Administration, Sham Intervention
Medical subject headings
Erectile Dysfunction, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerve-Sparing ProstatectomyProcedure or surgery

    Also called nerve-sparing radical prostatectomy, nerve-sparing surgery

    Undergo nerve-sparing prostatectomy per standard of care

  • Medical Device Usage and EvaluationOther

    Receive LiSWT

  • Duplex UltrasoundProcedure or surgery

    Also called DD, Duplex Doppler, Duplex Doppler Ultrasound

    Undergo DDUS

  • Survey AdministrationOther

    Ancillary studies

  • Nerve-Sparing ProstatectomyProcedure or surgery

    Also called nerve-sparing radical prostatectomy, nerve-sparing surgery

    Undergo nerve-sparing prostatectomy per standard of care

  • Sham InterventionProcedure or surgery

    Also called Sham Comparator

    Receive sham LiSWT

  • Duplex UltrasoundProcedure or surgery

    Also called DD, Duplex Doppler, Duplex Doppler Ultrasound

    Undergo DDUS

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT05877144
Study groupRoleWhat they receive
ARM I (LiSWT)ExperimentalPatients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.
Receives: Procedure: Nerve-Sparing Prostatectomy; Other: Medical Device Usage and Evaluation; Procedure: Duplex Ultrasound; Other: Survey Administration
ARM II (sham LiSWT)Sham comparatorPatients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.
Receives: Procedure: Nerve-Sparing Prostatectomy; Procedure: Sham Intervention; Procedure: Duplex Ultrasound; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient reported sexual function

    Will be assessed using the International Index of Erectile Function (IIEF) The IIEF is a15-item questionnaire - each item scored from 0 to 5 - examines five main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

    Measured: At 6 months post low intensity shockwave therapy (LiSWT) initiation

  2. Patient reported sexual function

    Will be assessed using the Erection Hardness Scale (EHS). The EHS is a single-item validated Likert scale. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

    Measured: At 6 months post low intensity shockwave therapy (LiSWT) initiation

Secondary outcomes (6)

  1. Change in duplex doppler ultrasound measurement

    Will be assessed by penile flow parameters. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval. Outcomes measured only at 6 months post randomization will be analyzed using analysis of covariance with adjustment for the baseline value.

    Measured: Baseline to 6 months post LiSWT initiation

  2. Erectile function

    Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval.

    Measured: At 1 month following LiSWT initiation

  3. Erectile function

    Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval.

    Measured: At 3 month following LiSWT initiation

  4. Erectile function

    Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval.

    Measured: At 6 month following LiSWT initiation

  5. Erectile function

    Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval.

    Measured: At 9 month following LiSWT initiation

  6. Erectile function

    Will be assessed using the IIEF, EHS, Sexual Encounter Profile diary and the Patient Global Impression of Improvement survey scores. Mixed effect linear regression will be used to model post randomization repeated measurements of continuous outcomes. From the results of the model, will estimate the mean difference between groups at each time point along with a 95% confidence interval.

    Measured: At 12 month following LiSWT initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start6 Jul 2023
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Resources

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
No Data Available
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877144
Sponsor's protocol ID
iRISID-2022-0980
Other IDs
JT 22705
Status last verified
Jul 2025
First submitted
5 May 2023
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nerve-Sparing Prostatectomy, Medical Device Usage and Evaluation and Duplex Ultrasound in people with Erectile Dysfunction and Localized Prostate Carcinoma, run by Thomas Jefferson University at 1 site in United States.

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 9 inclusion and 14 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: finished, as of the sponsor's last update on 15 Jul 2025. 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 States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient reported sexual function (time frame: At 6 months post low intensity shockwave therapy (LiSWT) initiation). The study lists 2 primary outcomes in all. 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 NCT05877144.

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 15 Jul 2025.

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