An interventional study of Transcutaneous Electrical Nerve Stimulation in Urinary Calculus, sponsored by Bozok University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Bozok University · Not applicable, Interventional, and Treatment
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.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's enrollment of 72 is below the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Bozok University is the lead sponsor of 53 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 (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.
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 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
Time frame: 0-24 hours postoperatively
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
Time frame: 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
Time frame: 24 hours postoperatively
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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 24 hours postoperatively
Plan to share: 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.
Supporting information: Statistical analysis plan
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.
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