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.
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
- Conditions the study is for
- Erectile Dysfunction, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8
- 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
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:
- 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:
- 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.
- Conditions
- Erectile Dysfunction, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- 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 group | Role | What they receive |
|---|---|---|
| ARM I (LiSWT) | Experimental | 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. Receives: Procedure: Nerve-Sparing Prostatectomy; Other: Medical Device Usage and Evaluation; Procedure: Duplex Ultrasound; Other: Survey Administration |
| ARM II (sham LiSWT) | Sham comparator | 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. 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.
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
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)
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
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
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
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
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
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.
- First posted26 May 2023
- Study start6 Jul 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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
- No Data Available
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Erectile Function With Early Postoperative Application of Low Intensity Shockwave Therapy After Nerve Sparing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT05877144
- Acronym / sponsor ID
- iRISID-2022-0980
- Conditions
- Erectile Dysfunction, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 26 May 2023 (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.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- No Data Available
| Arm | Type | Receives |
|---|---|---|
| ARM I (LiSWT) | Experimental | Procedure: Nerve-Sparing Prostatectomy, Other: Medical Device Usage and Evaluation, Procedure: Duplex Ultrasound, Other: Survey AdministrationPatients 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 (sham LiSWT) | Sham comparator | Procedure: Nerve-Sparing Prostatectomy, Procedure: Sham Intervention, Procedure: Duplex Ultrasound, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- • Subject does not speak or understand English
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 |
|---|---|---|
| Nerve-Sparing ProstatectomyAlso: nerve-sparing radical prostatectomy, nerve-sparing surgeryUndergo nerve-sparing prostatectomy per standard of care | Procedure or surgery | ARM I (LiSWT) |
| Medical Device Usage and EvaluationReceive LiSWT | Other | ARM I (LiSWT) |
| Duplex UltrasoundAlso: DD, Duplex Doppler, Duplex Doppler UltrasoundUndergo DDUS | Procedure or surgery | ARM I (LiSWT) |
| Survey AdministrationAncillary studies | Other | ARM I (LiSWT) |
| Nerve-Sparing ProstatectomyAlso: nerve-sparing radical prostatectomy, nerve-sparing surgeryUndergo nerve-sparing prostatectomy per standard of care | Procedure or surgery | ARM II (sham LiSWT) |
| Sham InterventionAlso: Sham ComparatorReceive sham LiSWT | Procedure or surgery | ARM II (sham LiSWT) |
| Duplex UltrasoundAlso: DD, Duplex Doppler, Duplex Doppler UltrasoundUndergo DDUS | Procedure or surgery | ARM II (sham LiSWT) |
| Survey AdministrationAncillary studies | Other | ARM II (sham LiSWT) |
Primary outcome
Patient reported sexual function
Time frame: At 6 months post low intensity shockwave therapy (LiSWT) initiation
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.
Patient reported sexual function
Time frame: At 6 months post low intensity shockwave therapy (LiSWT) initiation
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.
6 secondary outcomes
Change in duplex doppler ultrasound measurement
Time frame: Baseline to 6 months post LiSWT initiation
Erectile function
Time frame: At 1 month following LiSWT initiation
Erectile function
Time frame: At 3 month following LiSWT initiation
Erectile function
Time frame: At 6 month following LiSWT initiation
Erectile function
Time frame: At 9 month following LiSWT initiation
Erectile function
Time frame: At 12 month following LiSWT initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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?
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.