Urinary CalculusRIRS TENSNCT07405502
The Effect of Transcutaneous Electrical Nerve Stimulation in Patients After Retrograde Intrarenal Surgery
A study testing Transcutaneous Electrical Nerve Stimulation in people with Urinary Calculus, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to evaluate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on pain, nausea, vomiting, and quality of recovery in patients undergoing Retrograde Intrarenal Surgery (RIRS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urinary Calculus
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 May 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have undergone RIRS will be included in our study. Eligibility criteria include being between 18 and 70 years of age,
- Participants having an American Society of Anesthesiologists (ASA) physical status classification of I or II,
- Participants must have sufficient cognitive function and language skills to proceed with the study.
Who cannot join
- Exclusion criteria include the presence of a painful condition (e.g., inflammatory rheumatic disease, lumbar muscle degeneration, lumbar disc protrusion with back pain, acute or chronic nephritis, and pyelonephritis),
- Major organ system disease,
- Participants with pacemakers,
- Participants using analgesic medications or those with a history of significant drug abuse,
- Those with uncontrolled hypertension, diabetes or malignancies, a history of epilepsy, pregnancy, and breastfeeding,
- Participants in other clinical trials will also be excluded (Mora et al., 2007; Tu et al., 2019).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Nausea, Vomiting, and Quality of Recovery in Patients After Retrograde Intrarenal Surgery: A Randomized Controlled Trial
This study is designed to evaluate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on pain, nausea, vomiting, and quality of recovery in patients undergoing Retrograde Intrarenal Surgery (RIRS). This prospective, randomized controlled trial, designed as a two-group study, will be conducted at the Department of Urology, Yozgat Bozok University Health Practice and Research Center between September 2025 and September 2026. A total of 72 patients who underwent RIRC and met the inclusion criteria will be included in the study. Participants will be randomly divided into two groups: an intervention group receiving TENS (n=36) and a control group without TENS (n=36). Pain levels, frequency of nausea and vomiting, and quality of recovery in both groups will be compared within the first 24 hours postoperatively. This study is expected to provide evidence-based data on the effectiveness of TENS, a non-pharmacological method, in symptom management after RIRS.
- Conditions
- Urinary Calculus
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Retrograde Intrarenal Surgery, Quality of Recovery
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
This intervention is distinguished by the early, standardized, and nonpharmacological application of Transcutaneous Electrical Nerve Stimulation (TENS) within the first 24 hours following Retrograde Intrarenal Surgery (RIRS). Unlike conventional postoperative management that primarily relies on pharmacological analgesics and antiemetics, this approach emphasizes a nurse-administered, bedside, and patient-centered neuromodulation technique that is integrated into routine care without adding invasive procedures. The use of uniform stimulation parameters, predefined electrode placement protocols, and blinded outcome assessment ensures consistency and methodological rigor, allowing the specific effects of TENS on postoperative pain, nausea, vomiting, and quality of recovery to be isolated and compared reliably against standard care.
| Study group | Role | What they receive |
|---|---|---|
| TENS group | Experimental | Intervention Arm (TENS Group): Participants in this arm will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard postoperative care following Retrograde Intrarenal Surgery (RIRS). TENS will be applied using surface electrodes placed on the appropriate dermatomal areas related to the surgical site. The stimulation parameters (frequency, intensity, and duration) will be standardized for all participants and administered within the first 24 hours postoperatively. The intervention aims to reduce postoperative pain, as well as the frequency of nausea and vomiting, and to improve overall quality of recovery. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
| Control Arm | No intervention | Control Arm (Standard Care Group): Participants in this arm will receive standard postoperative care only, without any TENS application. Standard care will include routine monitoring, prescribed analgesic and antiemetic medications as needed, mobilization, and nursing care according to institutional protocols. Outcomes related to pain, nausea, vomiting, and quality of recovery will be assessed at the same time points as in the intervention arm to allow for valid comparison between groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure (postoperative pain intensity)
The primary outcome of this study is the intensity of postoperative pain within the first 24 hours following retrograde intrarenal surgery (RIRS). Pain level will be assessed using the validated and reliable Numerical Rating Scale (NRS).
Scale Description:
Scale name: Numerical Rating Scale (NRS) Minimum value: 0 (no pain) Maximum value: 10 (unbearable pain) Higher score: Indicates a worse clinical outcome Unit of Measure: Scale total score
Measured: 0-24 hours postoperatively
Secondary outcomes (2)
Postoperative Nausea and Vomiting (PONV) Intensity Scale
The frequency and severity of nausea and vomiting occurring within the first 24 hours after surgery will be assessed and recorded using the Postoperative Nausea and Vomiting (PONV) Intensity Scale.
Scale Description:
Scale name: Postoperative Nausea and Vomiting (PONV) Intensity Scale Minimum value: 0 (no nausea/vomiting) Maximum value: 4 (severe and persistent nausea/vomiting) Higher score: Indicates a worse clinical outcome Unit of Measure: Scale total score
Measured: 0-24 hours postoperatively
Quality of recovery
The quality of postoperative recovery will be assessed using the Quality of Recovery-15 Questionnaire (QoR-15), which has proven validity and reliability.
Scale Description:
Scale name: Quality of Recovery-15 (QoR-15) Minimum value: 0 Maximum value: 150 Higher score: Indicates better recovery quality Unit of Measure: Scale total score
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Dec 2025
- Study completion1 May 2026
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 Urinary CalculusStudies 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
- This study employs a prospective, randomized, controlled, two-arm intervention model. Eligible participants will be randomly assigned to either the TENS intervention group or the control group using a simple randomization method. The intervention group will receive standardized TENS applications during the first 24 hours postoperatively in addition to routine postoperative care, while the control group will receive routine care only. Outcome measures, including pain intensity, frequency of nausea and vomiting, and quality of recovery, will be assessed at predefined time points using validated measurement scales by blinded assessors to minimize bias. Data will be analyzed comparatively between groups to determine the effectiveness of the intervention.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sahin Akboga, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405502
- Sponsor's protocol ID
- Yozgat Bozok Univercity
- Other IDs
- SRPC
- Acronym
- RIRS TENS
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) generated in this study-including demographic characteristics, baseline clinical variables, intervention allocation, outcome measures (pain scores, nausea and vomiting frequency, quality of recovery scores), and related metadata-will be made available upon reasonable request. Data will be shared with academic institutions, regulatory bodies, or scientific journals for purposes of verification, secondary analysis, or publication requirements, subject to approval by the study's ethics committee and the execution of a data use agreement to ensure confidentiality, ethical use, and compliance with applicable data protection regulations.
Publications
Kim, H. Y., Park, J. H., & Yoon, H. J. (2020). The effects of transcutaneous electrical nerve stimulation on postoperative pain and recovery in patients undergoing urological surgery: A randomized controlled trial. Journal of Urology and Renal Diseases, 5(2), 1035-1041. https://doi.org/10.23880/oajurd-16000201
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Nausea, Vomiting, and Quality of Recovery in Patients After Retrograde Intrarenal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07405502
- Acronym / sponsor ID
- RIRS TENS / Yozgat Bozok Univercity
- Conditions
- Urinary Calculus
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Retrograde Intrarenal Surgery, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 12 Feb 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.
This study is designed to evaluate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on pain, nausea, vomiting, and quality of recovery in patients undergoing Retrograde Intrarenal Surgery (RIRS). This prospective, randomized controlled trial, designed as a two-group study, will be conducted at the Department of Urology, Yozgat Bozok University Health Practice and Research Center between September 2025 and September 2026. A total of 72 patients who underwent RIRC and met the inclusion criteria will be included in the study. Participants will be randomly divided into two groups: an intervention group receiving TENS (n=36) and a control group without TENS (n=36). Pain levels, frequency of nausea and vomiting, and quality of recovery in both groups will be compared within the first 24 hours postoperatively. This study is expected to provide evidence-based data on the effectiveness of TENS, a non-pharmacological method, in symptom management after RIRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a prospective, randomized, controlled, two-arm intervention model. Eligible participants will be randomly assigned to either the TENS intervention group or the control group using a simple randomization method. The intervention group will receive standardized TENS applications during the first 24 hours postoperatively in addition to routine postoperative care, while the control group will receive routine care only. Outcome measures, including pain intensity, frequency of nausea and vomiting, and quality of recovery, will be assessed at predefined time points using validated measurement scales by blinded assessors to minimize bias. Data will be analyzed comparatively between groups to determine the effectiveness of the intervention.
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: Transcutaneous Electrical Nerve StimulationIntervention Arm (TENS Group): Participants in this arm will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard postoperative care following Retrograde Intrarenal Surgery (RIRS). TENS will be applied using surface electrodes placed on the appropriate dermatomal areas related to the surgical site. The stimulation parameters (frequency, intensity, and duration) will be standardized for all participants and administered within the first 24 hours postoperatively. The intervention aims to reduce postoperative pain, as well as the frequency of nausea and vomiting, and to improve overall quality of recovery. |
| Control Arm | No intervention | –Control Arm (Standard Care Group): Participants in this arm will receive standard postoperative care only, without any TENS application. Standard care will include routine monitoring, prescribed analgesic and antiemetic medications as needed, mobilization, and nursing care according to institutional protocols. Outcomes related to pain, nausea, vomiting, and quality of recovery will be assessed at the same time points as in the intervention arm to allow for valid comparison between groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who have undergone RIRS will be included in our study. Eligibility criteria include being between 18 and 70 years of age,
- Participants having an American Society of Anesthesiologists (ASA) physical status classification of I or II,
- Participants must have sufficient cognitive function and language skills to proceed with the study.
Key exclusion criteria (6 listed)
- Exclusion criteria include the presence of a painful condition (e.g., inflammatory rheumatic disease, lumbar muscle degeneration, lumbar disc protrusion with back pain, acute or chronic nephritis, and pyelonephritis),
- Major organ system disease,
- Participants with pacemakers,
- Participants using analgesic medications or those with a history of significant drug abuse,
- Those with uncontrolled hypertension, diabetes or malignancies, a history of epilepsy, pregnancy, and breastfeeding,
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 StimulationThis intervention is distinguished by the early, standardized, and nonpharmacological application of Transcutaneous Electrical Nerve Stimulation (TENS) within the first 24 hours following Retrograde Intrarenal Surgery (RIRS). Unlike conventional postoperative management that primarily relies on pharmacological analgesics and antiemetics, this approach emphasizes a nurse-administered, bedside, and patient-centered neuromodulation technique that is integrated into routine care without adding invasive procedures. The use of uniform stimulation parameters, predefined electrode placement protocols, and blinded outcome assessment ensures consistency and methodological rigor, allowing the specific effects of TENS on postoperative pain, nausea, vomiting, and quality of recovery to be isolated and compared reliably against standard care. | Device | TENS group |
Primary outcome
Primary Outcome Measure (postoperative pain intensity)
Time frame: 0-24 hours postoperatively
The primary outcome of this study is the intensity of postoperative pain within the first 24 hours following retrograde intrarenal surgery (RIRS). Pain level will be assessed using the validated and reliable Numerical Rating Scale (NRS). Scale Description: Scale name: Numerical Rating Scale (NRS) Minimum value: 0 (no pain) Maximum value: 10 (unbearable pain) Higher score: Indicates a worse clinical outcome Unit of Measure: Scale total score
2 secondary outcomes
Postoperative Nausea and Vomiting (PONV) Intensity Scale
Time frame: 0-24 hours postoperatively
Quality of recovery
Time frame: 24 hours postoperatively
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 7 Jul 2026.
- BackgroundKim, H. Y., Park, J. H., & Yoon, H. J. (2020). The effects of transcutaneous electrical nerve stimulation on postoperative pain and recovery in patients undergoing urological surgery: A randomized controlled trial. Journal of Urology and Renal Diseases, 5(2), 1035-1041. https://doi.org/10.23880/oajurd-16000201
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) generated in this study-including demographic characteristics, baseline clinical variables, intervention allocation, outcome measures (pain scores, nausea and vomiting frequency, quality of recovery scores), and related metadata-will be made available upon reasonable request. Data will be shared with academic institutions, regulatory bodies, or scientific journals for purposes of verification, secondary analysis, or publication requirements, subject to approval by the study's ethics committee and the execution of a data use agreement to ensure confidentiality, ethical use, and compliance with applicable data protection regulations.
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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 in people with Urinary Calculus, run by Bozok University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 7 Jul 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 Turkey (Türkiye). 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?
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?
Primary Outcome Measure (postoperative pain intensity) (time frame: 0-24 hours postoperatively). 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 NCT07405502, 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 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.