The Effect of Transcutaneous Electrical Nerve Stimulation in Patients After Retrograde Intrarenal Surgery (RIRS TENS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Calculus
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yozgat
    • Yozgat, Yozgat, Turkey (Türkiye), 66100
      • Yozgat Bozok Univercity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS group; 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.	Device: Transcutaneous Electrical Nerve Stimulation; 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.
No Intervention: Control Arm; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	24 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic and antiemetic consumption	Total doses of analgesic and antiemetic drugs administered within the first 24 hours post-surgery (in units/day) will be calculated from patient records. The average numbers obtained for both groups will be compared. Unit of Measure: Pharmacological consumption amount/number (units/day)	Post-surgery 0-24 hours
Antiemetic Consumption	Description: Total antiemetic drug consumption within the first 24 hours after surgery will be extracted from medical records. Unit of Measure: Total dose (units/day)	0-24 hours postoperatively
Time to First Mobilization	Description: Time from completion of surgery to first ambulation will be recorded under standardized clinical conditions. Unit of Measure: Minutes	Within 24 hours postoperatively
Patient Satisfaction with Postoperative Care	Description: Patient satisfaction with postoperative care will be assessed using a 0-10 Numerical Rating Scale (NRS), where higher scores indicate greater satisfaction. Unit of Measure: Scale total score (0-10)	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Bozok University
• Collaborators: The Scientific Research Project Fund of Yozgat Bozok University

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Recovery; Transcutaneous Electrical Nerve Stimulation; Retrograde Intrarenal Surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Pathological Conditions, Signs and Symptoms; Urinary Calculi; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: Yozgat Bozok Univercity; SRPC (Other Identifier: Yozgat Bozok University Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: January 2026-December 2027
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No