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

NCT ID: NCT06824298

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2026-09-03

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.

Detailed Description

Bladder tenesmus is defined as the condition where a person still feels the need to urinate even though they have urinated. It may be caused by a tumor growing in the bladder or pelvis, or it may be associated with other bladder problems such as bladder spasm and discomfort, retention, infection, stones, clots, and catheters. During urological surgery, urinary catheters are placed in patients to ensure patency of the urinary tract, and these catheters usually remain in place until the patient is mobilized after surgery. Although urinary catheter-related problems are reported in the literature as short-term and long-term problems depending on the duration of the catheter, these problems are classified as infectious and non-infectious complications. The most common urinary catheter complications have been reported to include anaphylaxis, cytotoxicity and hypersensitivity, symptomatic bacterial infection, catheter obstruction, hematuria, mechanical trauma (perforation and urine leakage), urethral fistula and urethral stenosis. In a systematic review by Hollingsworth et al., where the results of 37 studies were evaluated, it was reported that non-infectious complications related to urinary catheters were much higher than infection-related complications. In a multicenter study by Saint et al., it was reported that infections constituted 10.5% of urinary catheter-related complications, while non-infectious complications constituted 55.4%, and these complications included pain and discomfort, hematuria, and urgent need to urinate. There are many studies on the successful application of non-pharmacological agents in pain treatment. One of these methods is Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a method of applying controlled, low-voltage electrical current to the nervous system through electrodes placed on the skin and is widely used for postoperative pain control. Bladder tenesmus caused by a urinary catheter creates a feeling of a full bladder, causing pain and discomfort with symptoms of urgency and inability to urinate. This negatively affects the patient's comfort. Although urinary catheter-related complications have been extensively investigated, no comprehensive review has been conducted focusing on identifying and analyzing the complication of bladder tenesmia and urgency caused by mechanical interaction due to the physical contact of the urinary catheter. There is also no application in the literature to relieve symptoms associated with bladder tenesmus caused by Foley catheters in patients after urinary surgery. Therefore, this study was planned to investigate the effect of TENS application on pain and patient comfort associated with bladder tenesmus in the early postoperative period after urinary surgery.

Conditions

Urinary Surgery; Pain, Postoperative; Comfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TENS application group

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.

Group Type: EXPERIMENTAL

TENS

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TENS

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Özlem İbrahimoğlu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Özlem İbrahimoğlu, PhD

Role: CONTACT

oogutlu@gmail.com

+905436195971

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 23661258 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24042368 (View on PubMed)

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.

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Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

IstanbulMU8

Identifier Type: -

Identifier Source: org_study_id