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NCT Number: NCT06824298

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. TENS

    Time frame: First 24 hours after surgery

    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.

  2. TENS

    Time frame: First 24 hours after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Özlem İbrahimoğlu, PhD

CONTACT

[email protected]

+905436195971

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

Effect of TENS on Bladder Tenesmus-related Pain and Patient Comfort in the Early Postoperative Period After Urinary Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

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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