The Effect of Transcutaneous Electrical Nerve Stimulation in Patients After Retrograde Intrarenal Surgery

NCT07405502 | Active Not Recruiting

• 2 other identifiers: Yozgat Bozok UnivercitySRPC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Transcutaneous Electrical Nerve Stimulation; Retrograde Intrarenal Surgery; Quality of Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative Nausea and Vomiting (PONV) Intensity Scale

  0-24 hours postoperatively

• Quality of recovery

  24 hours postoperatively

Other Outcomes (4)

• Analgesic and antiemetic consumption

  Post-surgery 0-24 hours

• Antiemetic Consumption

  0-24 hours postoperatively

• Time to First Mobilization

  Within 24 hours postoperatively

Study Arms (2)

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.

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.

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

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.

TENS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bozok University: lead
• The Scientific Research Project Fund of Yozgat Bozok University: collaborator

Study Sites (1)

Yozgat Bozok Univercity

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Urinary Calculi

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 12, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: January 2026-December 2027
• 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.

Locations

TU (1)