Pudendal Nerve InjuryLow-NEEPNCT06397612
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
A study testing Low Dose in people with Pudendal Nerve Injury and Erectile Dysfunction, run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Pudendal Nerve Injury, Erectile Dysfunction, Electric Stimulation
- What is being tested?
- Low Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 28 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males Ages between 18-60 years old
- Primarily organic cause diagnosed by Doppler:
- Peak-systolic velocities (PSV).
- Tele-diastolic velocity (DTV).
- Resistance Index (RI) Patients with ≤ 6 months since first assessment. Initial IIEF-EF questionnaire scores: 11-25 points. (mild to moderate erectile dysfunction) Active sexual life (more than 4 attempts per month).
Who cannot join
- Pelvic surgeries History of Peyronie's disease Penile surgeries, except circumcision or frenuloplasty Priapism Pelvic radiation Female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry on the Short- and Medium-term Efficacy of Low-dose Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Pudendal Nerve in Patients With Erectile Dysfunction
Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings in the deeper tissues.
Read the detailed description
Patients will undergo continuous stimulation at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient, observing significant changes in erectile function after transanal stimulation at intensities between 20 and 100 mA.
- Being tested
- Low Dose
- Keywords
- Erectile Dysfunction, Percutaneous Electrical Neurostimulation, Low Dose, Pudendal Nerve
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low DoseOther
Patients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | The intervention protocol for Group I peripheral nerve electrostimulation will have the following parameters:
Patients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient. Receives: Other: Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF-EF)
It is an index that assesses erectile function in a purely subjective way. It is the most recognized and used, and consists of six questions in which the frequency and firmness of the erection, the capacity of penetration, the capacity and frequency of maintenance and the confidence in the erection are evaluated. According to the questionnaire, dysfunction is classified as: no ED (26-30 points), mild (22-25 points), mild to moderate (17-21 points), moderate (11-16 points) and very strong (6-10 points). A score equal to or greater than 4 points will be considered a significant change. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention.
Measured: 4 months
Erection Hardness Scale (EHS)
The following will be considered significant changes men who improved by more than 3 points what in the initial phase was below a score of 2 points. The questionnaire score depends on the rating of erection hardness according to the following parameters: 0 (penis does not enlarge); 1 (penis is larger, but not hard); 2 (penis is hard but not hard enough for penetration); 3 (penis is hard enough to penetrate, but not completely hard); and 4 (penis is completely hard and rigid). Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention.
Measured: 4 months
Premature Ejaculation Diagnostic Tool (PEDT)
Helps identify patients who may be suffering from premature ejaculation. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention.
Measured: 4 months
Quality of Life Scale
It is used to subjectively assess the patient's opinion of his or her quality of life, based on 4 main aspects: physical, psychological, social and environmental health.Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. The scale is measured by 26 items, divided into 4 dimensions. Each dimension is independent. The higher the score, the higher the patient's quality of life.
Measured: 4 months
Self-Esteem And Relationship Questionnaire (Sear)
A questionnaire used for research and/or clinical practice use on self-esteem, in this case for patients with erectile dysfunction. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. The scale is measured from 0 to 100 points, with 0 being the worst score and 100 being the best.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Dec 2023
- Primary completion15 Nov 2026 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pudendal Nerve InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study corresponds to a non-randomized, single treatment arm, prospective, multicenter study. The subject, the assignor, the physiotherapist, the statistician and a person in charge of activating the protocol will know the stimulation parameters, to adjust, monitor and apply the treatment.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Álvaro Navas Mosqueda, Principal investigator, Camilo Jose Cela Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397612
- Sponsor's protocol ID
- Low-NEEP
- Acronym
- Low-NEEP
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yafi FA, Jenkins L, Albersen M, Corona G, Isidori AM, Goldfarb S, Maggi M, Nelson CJ, Parish S, Salonia A, Tan R, Mulhall JP, Hellstrom WJ. Erectile dysfunction. Nat Rev Dis Primers. 2016 Feb 4;2:16003. doi: 10.1038/nrdp.2016.3.
PubMed 27188339Beltra P, Ruiz-Del-Portal I, Ortega FJ, Valdesuso R, Delicado-Miralles M, Velasco E. Sensorimotor effects of plasticity-inducing percutaneous peripheral nerve stimulation protocols: a blinded, randomized clinical trial. Eur J Pain. 2022 May;26(5):1039-1055. doi: 10.1002/ejp.1928. Epub 2022 Mar 3.
PubMed 35191131Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.
PubMed 20171677
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry on the Short- and Medium-term Efficacy of Low-dose Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Pudendal Nerve in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT06397612
- Acronym / sponsor ID
- Low-NEEP / Low-NEEP
- Keywords
- Erectile Dysfunction, Percutaneous Electrical Neurostimulation, Low Dose, Pudendal Nerve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 3 May 2024 (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 is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings in the deeper tissues.
Detailed description
Patients will undergo continuous stimulation at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient, observing significant changes in erectile function after transanal stimulation at intensities between 20 and 100 mA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study corresponds to a non-randomized, single treatment arm, prospective, multicenter study. The subject, the assignor, the physiotherapist, the statistician and a person in charge of activating the protocol will know the stimulation parameters, to adjust, monitor and apply the treatment.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Low DoseThe intervention protocol for Group I peripheral nerve electrostimulation will have the following parameters: Patients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males Ages between 18-60 years old
- Peak-systolic velocities (PSV).
- Tele-diastolic velocity (DTV).
- Resistance Index (RI) Patients with ≤ 6 months since first assessment. Initial IIEF-EF questionnaire scores: 11-25 points. (mild to moderate erectile dysfunction) Active sexual life (more than 4 attempts per month).
Key exclusion criteria (1 listed)
- Pelvic surgeries History of Peyronie's disease Penile surgeries, except circumcision or frenuloplasty Priapism Pelvic radiation Female
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 |
|---|---|---|
| Low DosePatients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient. | Other | Group I |
Primary outcome
International Index of Erectile Function (IIEF-EF)
Time frame: 4 months
It is an index that assesses erectile function in a purely subjective way. It is the most recognized and used, and consists of six questions in which the frequency and firmness of the erection, the capacity of penetration, the capacity and frequency of maintenance and the confidence in the erection are evaluated. According to the questionnaire, dysfunction is classified as: no ED (26-30 points), mild (22-25 points), mild to moderate (17-21 points), moderate (11-16 points) and very strong (6-10 points). A score equal to or greater than 4 points will be considered a significant change. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention.
Erection Hardness Scale (EHS)
Time frame: 4 months
The following will be considered significant changes men who improved by more than 3 points what in the initial phase was below a score of 2 points. The questionnaire score depends on the rating of erection hardness according to the following parameters: 0 (penis does not enlarge); 1 (penis is larger, but not hard); 2 (penis is hard but not hard enough for penetration); 3 (penis is hard enough to penetrate, but not completely hard); and 4 (penis is completely hard and rigid). Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention.
Premature Ejaculation Diagnostic Tool (PEDT)
Time frame: 4 months
Helps identify patients who may be suffering from premature ejaculation. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention.
Quality of Life Scale
Time frame: 4 months
It is used to subjectively assess the patient's opinion of his or her quality of life, based on 4 main aspects: physical, psychological, social and environmental health.Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. The scale is measured by 26 items, divided into 4 dimensions. Each dimension is independent. The higher the score, the higher the patient's quality of life.
Self-Esteem And Relationship Questionnaire (Sear)
Time frame: 4 months
A questionnaire used for research and/or clinical practice use on self-esteem, in this case for patients with erectile dysfunction. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. The scale is measured from 0 to 100 points, with 0 being the worst score and 100 being the best.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 27188339Yafi FA, Jenkins L, Albersen M, Corona G, Isidori AM, Goldfarb S, Maggi M, Nelson CJ, Parish S, Salonia A, Tan R, Mulhall JP, Hellstrom WJ. Erectile dysfunction. Nat Rev Dis Primers. 2016 Feb 4;2:16003. doi: 10.1038/nrdp.2016.3.
- Background: PubMed 35191131Beltra P, Ruiz-Del-Portal I, Ortega FJ, Valdesuso R, Delicado-Miralles M, Velasco E. Sensorimotor effects of plasticity-inducing percutaneous peripheral nerve stimulation protocols: a blinded, randomized clinical trial. Eur J Pain. 2022 May;26(5):1039-1055. doi: 10.1002/ejp.1928. Epub 2022 Mar 3.
- Background: PubMed 20171677Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.
- Individual participant dataSharing planned: No
Related trials for Pudendal Nerve Injury
Enrolling by invitationObservational study
Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
Perineal Laceration, Tear, or Rupture During Delivery
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.
Álvaro Navas Mosqueda principal investigator
Camilo Jose Cela Univerity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose in people with Pudendal Nerve Injury and Erectile Dysfunction, run by Camilo Jose Cela University at 1 site in Spain.
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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. 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 Spain. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
International Index of Erectile Function (IIEF-EF) (time frame: 4 months). The study lists 5 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 NCT06397612, which also lists 3 linked publications.
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 21 Oct 2026.