Prostate CancerNCT07331246
TENS for Pain Relief During Fusion-Guided Prostate Biopsy
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Local Anesthesia in people with Prostate Cancer and Prostate Biopsy, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The goal of this clinical trial is to learn whether transcutaneous electrical nerve stimulation (TENS) can reduce pain during transperineal prostate biopsy in adult male patients. It will also assess the safety and tolerability of using TENS in this setting. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Biopsy, Fusion Biopsy
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) and Local Anesthesia
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2023to 30 Jul 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspicious lesions on multiparametric MRI, classified as PI-RADS score ≥ 3
- The indication for mpMRI was based on the presence of at least one of the following:
- Elevated serum prostate-specific antigen (PSA) levels
- Abnormal digital rectal examination (DRE)
Who cannot join
- Prior treatment of prostate cancer
- Contraindications to TENS, including:
- Cutaneous damage or dermatologic conditions at the TENS application sites
- Presence of cardiac pacemakers or automatic implantable cardioverter-defibrillators (AICDs)
- Uncontrolled cardiac arrhythmias or congestive heart failure
- History of epilepsy or seizure disorders
Show all 15Show fewer
- Metal implants near the site of stimulation
- Malignancy at or near the site of stimulation
- Contraindications to transperineal biopsy, including:
- Active urinary tract infection
- Bleeding disorders or ongoing anticoagulant therapy
- Anatomical abnormalities that prevent safe access to the prostate
- Known allergy or intolerance to local anesthetics or biopsy-related materials
- Severe comorbidities or unstable medical conditions that could compromise procedural safety
- Inability to provide informed consent or refusal to sign the consent form
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Urology, Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-214
About this study
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: An Exploratory Single-Center, Randomized, Placebo-Controlled Trial
The goal of this clinical trial is to learn whether transcutaneous electrical nerve stimulation (TENS) can reduce pain during transperineal prostate biopsy in adult male patients. It will also assess the safety and tolerability of using TENS in this setting. The main questions it aims to answer are:
Does TENS lower patient-reported pain during local anesthesia and prostate biopsy sampling?
Read more
Are there any side effects or complications associated with using TENS during the procedure?
Researchers will compare TENS to a placebo (sham TENS with no active stimulation) and to standard care (local anesthesia alone).
Participants will:
Be randomly assigned to receive either TENS + local anesthesia, sham TENS + local anesthesia, or local anesthesia alone
Undergo a standard transperineal prostate biopsy guided by MRI-ultrasound fusion
Report their pain levels during four specific stages of the procedure
Attend a follow-up visit 3-4 weeks after the biopsy to review results and assess for any side effects
- Conditions
- Prostate Cancer, Prostate Biopsy, Fusion Biopsy, Pain Management
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS), Local Anesthesia
- Medical subject headings
- Prostatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called TENS Therapy, Electrical Nerve Stimulation
Application of transcutaneous electrical nerve stimulation (TENS) using two pairs of adhesive electrodes placed in the perineal region. Electrical stimulation was initiated 3-5 minutes before local anesthetic infiltration and continued throughout the biopsy procedure. The device used symmetrical biphasic pulses at 80 Hz with a pulse width of 180 μs. Amplitude was adjusted to the maximum comfortable level for each participant. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure.
Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)Device
Also called Sham TENS, Placebo TENS, Inactive Electrical Stimulation
Application of sham transcutaneous electrical nerve stimulation (TENS) using identical electrode placement and device setup as the active TENS group, but without delivery of electrical current. The device was powered on but modified to prevent active stimulation. Participants were not informed of the inactive nature of the intervention. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure.
Local AnesthesiaProcedure or surgery
Also called Perineal Infiltration and Periprostatic Nerve Block, Standard Transperineal Local Anesthesia
Administration of 1% lignocaine (20 mL total) using a full needle path technique for anesthesia of the perineal skin and periprostatic tissue. No TENS electrodes or placebo stimulation applied. This represents standard of care anesthesia during transperineal MRI-ultrasound fusion-guided prostate biopsy.
| Study group | Role | What they receive |
|---|---|---|
| A. Local Anesthesia Only (Control Group) | Active comparator | Participants receive standard local anesthesia for transperineal MRI-ultrasound fusion-guided prostate biopsy using 1% lignocaine (20 mL total). No additional intervention is applied. Receives: Procedure: Local Anesthesia |
| B. TENS + Local Anesthesia | Experimental | Participants receive transcutaneous electrical nerve stimulation (TENS) applied to the perineum in addition to standard local anesthesia. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: Local Anesthesia |
| C. Sham TENS + Local Anesthesia | Placebo comparator | Participants receive sham (inactive) TENS with standard local anesthesia. Electrodes are applied as in Group B, but no electrical stimulation is delivered. Receives: Device: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS); Procedure: Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during transperineal prostate biopsy
Pain will be measured using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at four key stages of the procedure: (1) ultrasound probe insertion, (2) perineal skin infiltration, (3) peri-prostatic nerve block, and (4) biopsy sampling.
Measured: Immediately after each procedural stage (within 30 seconds)
Secondary outcomes (3)
Incidence of adverse events related to biopsy or TENS application
All adverse events will be recorded, including skin irritation, discomfort, bleeding, urinary retention, or infection. Events will be classified using the Clavien-Dindo system.
Measured: Up to 30 days after biopsy
Participant perception of TENS activity (blinding assessment)
After the procedure, participants in the TENS or sham groups will be asked whether they believed the TENS device was active. Responses will be used to evaluate the effectiveness of participant blinding.
Measured: Immediately after the procedure
Correlation between number of biopsy cores and pain score
Spearman correlation will be used to assess whether the number of biopsy cores taken per lesion is associated with increased patient-reported pain during the sampling phase of the biopsy procedure.
Measured: Immediately after biopsy sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Dec 2023
- Primary completion30 May 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartłomiej Marczak, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331246
- Sponsor's protocol ID
- KB/531/2023, KB/531-116/2025
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) to be shared will include: De-identified participant-level data relevant to primary and secondary outcome measures Pain score responses at each procedural stage (Numeric Rating Scale data) Group assignment (active TENS, sham TENS, or control) Adverse event data (Clavien-Dindo classification) Demographic and baseline clinical data (age, PSA level, BMI, prostate volume) No identifying information (e.g., names, birth dates, or hospital IDs) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: An Exploratory Single-Center, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07331246
- Acronym / sponsor ID
- KB/531/2023, KB/531-116/2025
- Conditions
- Prostate Cancer, Prostate Biopsy, Fusion Biopsy, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 9 Jan 2026 (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.
The goal of this clinical trial is to learn whether transcutaneous electrical nerve stimulation (TENS) can reduce pain during transperineal prostate biopsy in adult male patients. It will also assess the safety and tolerability of using TENS in this setting. The main questions it aims to answer are:
Does TENS lower patient-reported pain during local anesthesia and prostate biopsy sampling?
Are there any side effects or complications associated with using TENS during the procedure?
Researchers will compare TENS to a placebo (sham TENS with no active stimulation) and to standard care (local anesthesia alone).
Participants will:
Be randomly assigned to receive either TENS + local anesthesia, sham TENS + local anesthesia, or local anesthesia alone
Undergo a standard transperineal prostate biopsy guided by MRI-ultrasound fusion
Report their pain levels during four specific stages of the procedure
Attend a follow-up visit 3-4 weeks after the biopsy to review results and assess for any side effects
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A. Local Anesthesia Only (Control Group) | Active comparator | Procedure: Local AnesthesiaParticipants receive standard local anesthesia for transperineal MRI-ultrasound fusion-guided prostate biopsy using 1% lignocaine (20 mL total). No additional intervention is applied. |
| B. TENS + Local Anesthesia | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Procedure: Local AnesthesiaParticipants receive transcutaneous electrical nerve stimulation (TENS) applied to the perineum in addition to standard local anesthesia. |
| C. Sham TENS + Local Anesthesia | Placebo comparator | Device: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS), Procedure: Local AnesthesiaParticipants receive sham (inactive) TENS with standard local anesthesia. Electrodes are applied as in Group B, but no electrical stimulation is delivered. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suspicious lesions on multiparametric MRI, classified as PI-RADS score ≥ 3
- The indication for mpMRI was based on the presence of at least one of the following:
- Elevated serum prostate-specific antigen (PSA) levels
- Abnormal digital rectal examination (DRE)
Key exclusion criteria (15 listed)
- Prior treatment of prostate cancer
- Contraindications to TENS, including:
- Contraindications to transperineal biopsy, including:
- Known allergy or intolerance to local anesthetics or biopsy-related materials
- Severe comorbidities or unstable medical conditions that could compromise procedural safety
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: TENS Therapy, Electrical Nerve StimulationApplication of transcutaneous electrical nerve stimulation (TENS) using two pairs of adhesive electrodes placed in the perineal region. Electrical stimulation was initiated 3-5 minutes before local anesthetic infiltration and continued throughout the biopsy procedure. The device used symmetrical biphasic pulses at 80 Hz with a pulse width of 180 μs. Amplitude was adjusted to the maximum comfortable level for each participant. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure. | Device | B. TENS + Local Anesthesia |
| Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)Also: Sham TENS, Placebo TENS, Inactive Electrical StimulationApplication of sham transcutaneous electrical nerve stimulation (TENS) using identical electrode placement and device setup as the active TENS group, but without delivery of electrical current. The device was powered on but modified to prevent active stimulation. Participants were not informed of the inactive nature of the intervention. All participants underwent transperineal MRI-ultrasound fusion-guided prostate biopsy under local anesthesia. The study evaluated the effect of active versus sham transcutaneous electrical nerve stimulation (TENS) as an adjunct to pain management during the procedure. | Device | C. Sham TENS + Local Anesthesia |
| Local AnesthesiaAlso: Perineal Infiltration and Periprostatic Nerve Block, Standard Transperineal Local AnesthesiaAdministration of 1% lignocaine (20 mL total) using a full needle path technique for anesthesia of the perineal skin and periprostatic tissue. No TENS electrodes or placebo stimulation applied. This represents standard of care anesthesia during transperineal MRI-ultrasound fusion-guided prostate biopsy. | Procedure or surgery | A. Local Anesthesia Only (Control Group), B. TENS + Local Anesthesia, C. Sham TENS + Local Anesthesia |
Primary outcome
Pain intensity during transperineal prostate biopsy
Time frame: Immediately after each procedural stage (within 30 seconds)
Pain will be measured using the Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain) at four key stages of the procedure: (1) ultrasound probe insertion, (2) perineal skin infiltration, (3) peri-prostatic nerve block, and (4) biopsy sampling.
3 secondary outcomes
Incidence of adverse events related to biopsy or TENS application
Time frame: Up to 30 days after biopsy
Participant perception of TENS activity (blinding assessment)
Time frame: Immediately after the procedure
Correlation between number of biopsy cores and pain score
Time frame: Immediately after biopsy sampling
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 9 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) to be shared will include: De-identified participant-level data relevant to primary and secondary outcome measures Pain score responses at each procedural stage (Numeric Rating Scale data) Group assignment (active TENS, sham TENS, or control) Adverse event data (Clavien-Dindo classification) Demographic and baseline clinical data (age, PSA level, BMI, prostate volume) No identifying information (e.g., names, birth dates, or hospital IDs) will be shared.
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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 Transcutaneous Electrical Nerve Stimulation (TENS) and Local Anesthesia in people with Prostate Cancer and Prostate Biopsy, run by Medical University of Gdansk at 1 site in Poland.
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 4 inclusion and 15 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 9 Jan 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 Poland. 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?
Pain intensity during transperineal prostate biopsy (time frame: Immediately after each procedural stage (within 30 seconds)). 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 9 Jan 2026.