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NCT Number: NCT07405502

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yozgat Bozok Univercity

Yozgat, 66100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative Nausea and Vomiting (PONV) Intensity Scale

    Time frame: 0-24 hours postoperatively

    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

  2. Quality of recovery

    Time frame: 24 hours postoperatively

    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

Other outcomes

  1. Analgesic and antiemetic consumption

    Time frame: Post-surgery 0-24 hours

    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)

  2. Antiemetic Consumption

    Time frame: 0-24 hours postoperatively

    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)

  3. Time to First Mobilization

    Time frame: Within 24 hours postoperatively

    Description: Time from completion of surgery to first ambulation will be recorded under standardized clinical conditions.

    Unit of Measure: Minutes

  4. Patient Satisfaction with Postoperative Care

    Time frame: 24 hours postoperatively

    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)

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study 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

Acronym: RIRS TENS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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