Effect of TENS on Bladder Tenesmus-related Pain and Patient Comfort After Urinary Surgery

NCT06824298 | Not Yet Recruiting

• 1 other identifier: IstanbulMU8
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bladder tenesmu is defined as the need to urinate despite the person urinating and is associated with various causes such as bladder spasm, infection, stones, catheters. Catheters used in urinary surgeries can cause various complications, especially pain and discomfort. There is no sufficient study in the literature on bladder tenesmus caused by mechanical interactions related to urinary catheters, and this situation negatively affects patient comfort. Transcutaneous Electrical Nerve Stimulation (TENS) is an effective method of reducing pain with low-voltage electrical current. However, there are no studies on the application of TENS in the management of symptoms associated with bladder tenesmus after urinary surgery. This study aims to investigate the effect of TENS application on bladder tenesmus-related pain and patient comfort in the early postoperative period after urinary surgery.

Conditions

Urinary Surgery; Pain, Postoperative; Comfort

Keywords

Bladder tenesmus; Pain; Comfort; Nursing care

Outcome Measures

Primary Outcomes (2)

• TENS

  Change in pain score related to bladder tenesmus as measured by Visual Analog Scale (VAS) at 0, 15, and 30 minutes, and 6, 12, and 24 hours post-intervention.

  First 24 hours after surgery

• TENS

  Change in patient comfort score related to bladder tenesmus as measured by Numeric Rating Scale (NRS) at 0, 15, and 30 minutes, and 6, 12, and 24 hours post-intervention.

  First 24 hours after surgery

Study Arms (2)

TENS application group

EXPERIMENTAL

Before surgery: The socio-demographic data of the patients will be recorded. During surgery: After patients are taken to the operating room and anesthesia is induced, TENS electrodes will be attached to the paravertebral muscles at the level of Lumbar vertebrae 2, 3 and Sacral Vertebrae 2, 3. After the surgery is completed, TENS will be activated before the patient is woken up. TENS settings: In modulation type, medium intensity contractions will be given at a frequency ranging from 60-80 Hertz to 1-5 Hertz, with a current rate ranging from 50-100 microseconds to 150-200 microseconds. After surgery: TENS will continue to be applied to patients in the recovery room for 30 minutes after the surgery. Patients will be evaluated by researchers in terms of pain and comfort associated with bladder tenesmus at 0, 15 and 30 minutes in the recovery room and at 6, 12 and 24 hours in the postoperative ward.

Other: TENS

Control group

NO INTERVENTION

Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of pain and comfort associated with bladder tenesmus at 0, 15 and 30 minutes in the recovery room and at 6, 12 and 24 hours in the postoperative ward.

Interventions

TENS OTHER

Before surgery: The socio-demographic data of the patients will be recorded. During surgery: After patients are taken to the operating room and anesthesia is induced, TENS electrodes will be attached to the paravertebral muscles at the level of Lumbar vertebrae 2, 3 and Sacral Vertebrae 2, 3. After the surgery is completed, TENS will be activated before the patient is woken up. TENS settings: In modulation type, medium intensity contractions will be given at a frequency ranging from 60-80 Hertz to 1-5 Hertz, with a current rate ranging from 50-100 microseconds to 150-200 microseconds. After surgery: TENS will continue to be applied to patients in the recovery room for 30 minutes after the surgery. Patients will be evaluated by researchers in terms of pain and comfort associated with bladder tenesmus at 0, 15 and 30 minutes in the recovery room and at 6, 12 and 24 hours in the postoperative ward.

TENS application group

Eligibility Criteria

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

You may qualify if:

• Being 18 years or older
• To undergo endoscopic urological surgery (Transurethral prostate resection/bladder surgery)
• Having an ASA score of 1-2
• Inserting a urinary catheter during surgery
• To be willing to participate in the study

You may not qualify if:

• To undergo emergency surgery
• Being under the age of 18
• Having an ASA score of 3 and above
• Having a urinary catheter inserted before surgery
• Not agreeing to participate in the study

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Related Publications (10)

• Finegan, W. C., McGurk, A., O'Donnell, W., Pederson, J., & Rogerson, E. (2018). Tenezm. In Care of the Cancer Patient (pp. 196-197). CRC Press.

  BACKGROUND

• Dellimore KH, Helyer AR, Franklin SE. A scoping review of important urinary catheter induced complications. J Mater Sci Mater Med. 2013 Aug;24(8):1825-35. doi: 10.1007/s10856-013-4953-y. Epub 2013 May 10.

  PMID: 23661258 BACKGROUND

• Hollingsworth JM, Rogers MA, Krein SL, Hickner A, Kuhn L, Cheng A, Chang R, Saint S. Determining the noninfectious complications of indwelling urethral catheters: a systematic review and meta-analysis. Ann Intern Med. 2013 Sep 17;159(6):401-10. doi: 10.7326/0003-4819-159-6-201309170-00006.

  PMID: 24042368 BACKGROUND

• Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417.

  PMID: 29971436 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Bulut H, Erden S, Demir SG, Cakar B, Erdogan Z, Demir N, Ay A, Aydin E. The Effect of Cold Vapor Applied for Sore Throat in the Early Postoperative Period. J Perianesth Nurs. 2016 Aug;31(4):291-7. doi: 10.1016/j.jopan.2014.10.005. Epub 2016 Feb 24.

  PMID: 27444760 BACKGROUND

• Erden, S., & Şenol Çelik, S. (2015). Bir elektro analjezi yöntemi: transkütan elektriksel sınır stimülasyonu ve hemşirenin rolleri. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 2(1), 50-60.

  BACKGROUND

• Johnson, M. I. (2017). Pain Management and Clinical Effectiveness of TENS. Critical Reviews™ in Physical and Rehabilitation Medicine, 29(1-4).

  BACKGROUND

• Vance CGT, Dailey DL, Chimenti RL, Van Gorp BJ, Crofford LJ, Sluka KA. Using TENS for Pain Control: Update on the State of the Evidence. Medicina (Kaunas). 2022 Sep 22;58(10):1332. doi: 10.3390/medicina58101332.

  PMID: 36295493 BACKGROUND

• Song B, Chang Y, Li Y, Zhu J. Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized Controlled Trial. Nat Sci Sleep. 2020 Oct 27;12:809-819. doi: 10.2147/NSS.S270739. eCollection 2020.

  PMID: 33154688 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Özlem İbrahimoğlu, PhD

CONTACT

+905436195971; oogutlu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients who were hospitalized for urinary surgery and met the sample selection criteria will be included in the experimental and control groups by block randomization method using the random numbers table on the computer.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 13, 2025
• Study Start: March 3, 2025
• Primary Completion: March 3, 2026
• Study Completion (Estimated): September 3, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share