The risk of intra-urethral Foley catheter balloon inflation in spinal cord-injured patients: Lessons learned from a retrospective case series

Background Inflating the balloon of Foley catheter in urethra is a complication of urethral catheterisation. We report five patients in whom this complication occurred because of unskilled catheterisation. Due to lack of awareness, the problem was not recognised promptly and patients came to harm. Case series A tetraplegic patient developed pain in lower abdomen and became unwell after transurethral catheterisation. CT pelvis revealed full bladder with balloon of Foley catheter in dilated urethra. Routine ultrasound examination in an asymptomatic tetraplegic patient with urethral catheter drainage, revealed Foley balloon in the urethra. He was advised to get catheterisations done by senior health professionals. A paraplegic patient developed bleeding and bypassing after transurethral catheterisation. X-ray revealed Foley balloon in urethra; urethral catheter was changed ensuring its correct placement in urinary bladder. Subsequently, balloon of Foley catheter was inflated in urethra several times by community nurses, which resulted in erosion of bulbous urethra and urinary fistula. Suprapubic cystostomy was performed. A tetraplegic patient developed sweating and increased spasms following urethral catheterisations. CT of abdomen revealed distended bladder with the balloon of Foley catheter located in urethra. Flexible cystoscopy and transurethral catheterisation over a guide-wire were performed. Patient noticed decrease in sweating and spasms. A paraplegic patient developed lower abdominal pain and nausea following catheterisation. CT abdomen revealed bilateral hydronephrosis and hydroureter and Foley balloon located in urethra. Urehral catheterisation was performed over a guide-wire after cystoscopy. Subsequently suprapubic cystostomy was done. Conclusion Spinal cord injury patients are at increased risk for intra-urethral Foley catheter balloon inflation because of lack of sensation in urethra, urethral sphincter spasm, and false passage due to previous urethral trauma. Education and training of doctors and nurses in proper technique of catheterisation in spinal cord injury patients is vital to prevent intra-urethral inflation of Foley catheter balloon. If a spinal cord injury patient develops bypassing or symptoms of autonomic dysreflexia following catheterisation, incorrect placement of urethral catheter should be suspected.


Introduction
In 2010, we proposed that incorrect placement of a Foley catheter leading to inflation of Foley balloon in urethra in a spinal cord injury patient should be declared as a "never event" [1]. Although several advances have been made in management of spinal cord injury patients during this decade, we continue to see this complication of Foley catheter balloon inflation in urethra in spinal cord injury patients. We present five patients, in whom we detected this complication between 2012 and 2015 when these patients visited spinal injuries centre; it is possible that some other patients had developed this complication which went either undetected in the community or managed symptomatically in general hospitals without being recognised. The aim of this report is to raise awareness among health professionals in order to prevent intra-urethral Foley catheter balloon inflation in spinal cord injury patients and thereby reduce harm to patients.

Case 1
A 61-year-old male patient with tetraplegia attended a hospital as he was bypassing the indwelling urethral catheter. Transurethral catheterisation was performed by a health professional in the community. But, the catheter did not drain urine satisfactorily. The patient developed severe pain in lower abdomen; subsequently, he started getting pain in both kidneys as well; he developed loss of appetite and felt sick. He came to spinal unit after two weeks. On clinical examination, a long segment of Foley catheter was found to be lying outside penis. The patient was clear that the same length of catheter was lying outside his penis right from the time of insertion. Blood tests: C-reactive protein: 222.4 mg/L; urea: 1.8 mmol/L; Creatinine: 39umol/L. Clinical diagnosis was misplacement of urinary catheter in urethra with urosepsis.
CT of pelvis was requested to locate the position of the balloon of Foley catheter. However, CT of abdomen was performed, which revealed full bladder. Foley catheter was not seen within the urinary bladder ( Fig. 1 Left panel). This scan did not include pelvis; therefore precise location of the Foley balloon could not be ascertained. The patient was sent to radiology department again for scan of pelvis. CT of pelvis revealed fluid distension of the membranous and prostatic urethra ( Urethral catheter was removed; a Foley catheter with 20 ml balloon was inserted in the urinary bladder as a 10 ml balloon might slip through dilated bladder neck into urethra; turbid urine was drained. This patient was prescribed 160 mg of gentamicin followed by Ciprofloxacin by mouth. Three days later, the catheter got blocked; a district nurse changed the catheter; but inserted a Foley catheter with 10 ml balloon. The catheter did not drain urine satisfactorily and the patient came to spinal unit. On clinical examination, it was obvious that the catheter had been misplaced in the urethra, either got curled itself in dilated urethra during insertion or slipped into urethra subsequently. The Foley catheter had a radio-opaque marker; therefore, X-ray of pelvis was taken to find out precise location of the tip of the catheter. X-ray of pelvis revealed the tip of Foley catheter in the urethra. The catheter was removed and a Foley catheter with 20 ml balloon was inserted. The patient was reviewed after eleven days. The catheter was draining fine and patient was well.

Case 2
A 66-year-old, British Caucasian male, sustained hyperextension injury to neck in a bicycle accident in 2011. He developed tetraplegia at C-5. This patient had been managing his bladder by indwelling urethral catheter. Urethral catheter was being changed by district nurses. About 29 months after spinal injury, this patient came to spinal unit for routine ultrasound examination of urinary tract. Ultrasound revealed normal appearance of the kidneys, with no renal calculi or hydronephrosis; balloon of Foley catheter was not seen within the bladder. Urinary catheter had been misplaced, with catheter balloon in the urethra and not within the urinary bladder. Urethral catheter was removed and a size 14 French Foley catheter was inserted by a senior and experienced health professional. The patient was informed about incorrect placement of urethral catheter. We discussed with the patient precautions to be observed while inserting a catheter in order to ensure that the catheter was positioned correctly within the urinary bladder. He was advised to get transurethral catheterisations by senior health professionals. Follow-up ultrasound scan revealed the balloon of the catheter located in the bladder lumen which was otherwise empty.

Case 3
A 35-years-old, British Caucasian male, sustained complete paraplegia at T-11 level in 1982, as a result of road traffic accident. Neuropathic bladder was drained by indwelling urethral catheter. In 2012, urethral catheter was changed by a community health professional. There was considerable bleeding per urethra and urine was dark red. He developed rigors and received Trimethoprim 200 mg twice a day for seven days. In 2014, this patient came to spinal unit with the history of bypassing; no urine was going down the catheter. The precise location of the tip of catheter and Foley balloon needed to be checked. It was not possible to do CT or Ultrasound scan on that day. The catheter did not have radio-opaque marking. The patient was allergic to iodine; therefore, 5 ml of air was injected into Foley balloon and Xray of pelvis was taken. This X-ray revealed the balloon of Foley catheter in urethra ( Fig. 2 Left panel). Urethral catheter was removed and another catheter was inserted ensuring that the catheter was located within the bladder. Subsequently, urethral catheter was changed in the community. This patient developed skin breakdown and a cavity in the perineum. Urine was dripping continuously into the open cavity. The balloon of Foley catheter could be seen in the base of the cavity. MRI of pelvis revealed balloon of Foley catheter in the urethra ( Fig. 2 Right panel). Suprapubic cystostomy was performed using Seldinger technique (Medi Plus, Unit 7, The Gateway Centre, Coronation Road, Cressex Business Park, High Wycombe HP12 3SU, UK). Following suprapubic cystostomy, the catheter has been draining. The cavity in perineum had shrunk considerably in size. Urine leak continued albeit to markedly lesser extent.

Case 4
A 30-year-old British Caucasian male sustained C-4 tetraplegia in 1988. In 1994, when the patient used the sacral stimulator, penis retracted and penile sheath came off; therefore, he decided to have indwelling urethral catheter In 1997, after routine change of urethral catheter, the catheter did not drain urine; he was taken to Accident and Emergency. When the balloon of Foley catheter was deflated, there was profuse bleeding per urethra. A stiff catheter was inserted. During the next change of catheter, Foley catheter was inserted per urethra and the balloon was inflated; but no urine drained. This patient was taken to Accident and Emergency once again; the balloon was deflated. There was bleeding per urethra. Flexible cystoscopy revealed dilated bulbous urethra, which indicated that the balloon of Foley catheter had been inflated in the urethra. This patient wished to continue with urethral catheter drainage. In 2011, a student nurse inflated the balloon of Foley catheter in urethra; this patient passed blood per urethra and through the catheter. He started getting increased spasms and sweating. A nurse tried to insert a catheter but there was bleeding. Then a doctor tried to insert a catheter per urethra but catheterisation was not possible. Another doctor tried to insert a catheter and again there was bleeding. This patient was taken to theatre; cystoscopy was done and a catheter was inserted per urethra. When the catheter was changed next time, this patient started getting lot of sweating; his spasms got worse. He underwent computed tomography of abdomen to evaluate his bowels. CT revealed distended bladder (Fig. 3 Left panel). The catheter balloon was inflated within the prostatic urethra (Fig. 3 Right panel), which would be the cause for incomplete drainage of urinary bladder. Flexible cystoscopy was performed. There was no false passage. But, prostate-membranous urethra was dilated, which indicated that the balloon of Foley catheter had been inflated in the urethra on past occasions. A 16 French Foley catheter was inserted over a 0.032" guide wire. Subsequently, urethral catheter was changed over a guide wire. Patient noticed a decrease in sweating and severity of spasms.

Case 5
A 16-year-old British male was knocked down by a car in 1991. This patient developed T-6 complete paraplegia.
He has been managing his bladder by transurethral catheter. Seventeen years after spinal cord injury, urethral catheterisation was difficult; cystoscopy revealed false passage in urethra. A Foley catheter was inserted over a guide-wire. Later, transurethral catheter was pulled out accidentally. Since then urethral catheterisation was performed with flexible cystoscopy and a guide-wire. In 2013, ultrasound of urinary tract revealed small calculi right kidney, largest at the lower pole 6 mm in diameter. No hydronephrosis. Bladder was catheterised and empty. In 2014, ultrasound scan showed no renal calculi; no hydronephrosis. In 2015, he developed malaise, lower abdominal pain, back ache and nausea. He was treated for urine infection. CT abdomen revealed moderate left hydronephrosis and hydroureter, and mild right hydronephrosis and hydroureter down to the bladder (Fig. 4 Top Left panel). Transurethral catheter was not seen in the urinary bladder (Fig. 4 Top Right panel); tip of catheter was present in urethra; Foley balloon was seen in the membranous urethra (Fig. 4 Bottom panel). Most likely, the catheter has been pulled inadvertently. Flexible cystoscopy was performed and a size 16 French Foley catheter with a 20 ml balloon was inserted. Bypassing of catheter and urine leak decreased after inserting a 20 ml balloon Foley catheter per urethra. Subsequently, open suprapubic cystostomy was performed as percutaneous access to urinary bladder was unsuccessful because of his body status and small capacity urinary bladder.

Risk factors for intra-urethral Foley catheter balloon inflation in spinal cord-injured patients
Lack of sensation in urethra as a result of spinal cord injury: when the balloon is inflated in urethra, a spinal cord injury patient may not complain of pain or discomfort; so the health professional may not realise that catheterisation has gone wrong. Trauma to urethra during previous catheterisations resulting in urethral false passage Spasm of pelvic floor muscles and urethral sphincter which prevent the catheter from entering the bladder and leads to curling of Foley catheter in urethra Altered anatomy of lower urinary tract due to surgery in the past e.g. bladder neck resection, sphincterotomy. Once the balloon of Foley catheter is inflated in urethra, the prostate-membranous urethra becomes dilated; during subsequent catheterisations, the tip of catheter gets doubled back in urethra instead of going straight into the bladder; thus the problem is likely to recur because of chronic dilatation of prostate-membranous urethra. Another reason is the habit of using spinal cord injury patients, especially elderly persons, for "practising clinical skills" by student nurses and trainee doctors, be it administration of intramuscular injection, or transurethral catheterisation. Unless this custom is halted, spinal cord injury patients will continue to suffer from iatrogenic complications and receive substandard clinical care [2].

Clinical features of intra-urethral Foley catheter balloon inflation in spinal cord-injured patients
If a spinal cord injury patient develops bypassing, symptoms of autonomic dysreflexia (headache, profuse sweating and flushing of the skin above the level of the lesion, goose bumps below the level of the lesion, blurred vision, nasal congestion) or increased spasms following transurethral catheterisation, incorrect placement of urethral catheter should be suspected.
Symptoms manifested by the five patients in this case series were: Acute Patient number 1 developed bypassing, kidney pain and became unwell. Patient number 4 developed urethral bleeding, increased spasms and sweating following change of urethral catheter. Patient number 5 developed urine infection and CT revealed bilateral hydronephrosis and hydroureter.

Chronic
Patient number 2, in whom the Foley catheter balloon had been inflated in urethra for weeks, remained asymptomatic. Incorrect placement of urethral catheter was detected during routine ultrasound scan of urinary tract. In patient number 3, recurrent inflation of the Foley balloon in urethra resulted in erosion of urethra, breakdown of the skin in perineum and urinary fistula.
The wide spectrum of symptoms of intra-urethral inflation of Foley catheter balloon inflation is summarised below: Acute (symptoms occurring soon after inflating the Foley balloon in urethra) i. Bypassing and unsatisfactory drainage through the catheter ii. Lower abdominal pain, kidney pain iii. Clinical features of autonomic dysreflexia commonly manifesting as sweating, headache and increased spasms Chronic (symptoms occurring when the Foley balloon remains inflated in urethra for some time) i. Urine infection and urosepsis ii. Bilateral hydronephrosis and hydroureter leading to kidney injury iii. Erosion of urethra, urethral fistula iv. Skin breakdown in perineum where the Foley balloon had been kept inflated for prolonged period.

Diagnosis of intra-urethral Foley catheter balloon inflation in spinal cord-injured patients
When a spinal cord injury patient with indwelling urethral catheter develops bypassing or symptoms of autonomic dysreflexia after transurethral catheterisation, incorrect placement of catheter should be considered. Irrigating the catheter for isovolumetric return and physical examination assessing the length of exposed catheter are often sufficient to diagnose the problem. If the balloon of a Foley catheter is inflated in urethra, an excessive length of catheter will remain outside the penis. This sign is termed "long catheter sign" [3]. Conclusions and Take home message 1. Spinal cord injury patients are at increased risk for inflation of Foley catheter balloon in urethra because of lack of sensation in urethra, urethral sphincter spasm, and previous urethral trauma resulting in false passage.

Education and training of doctors and nurses in
proper technique of catheterisation in spinal cord injury patients is vital to prevent inflation of Foley catheter balloon in urethra.
3. If a spinal cord injury patient develops bypassing or symptoms of autonomic dysreflexia following transurethral catheterisation, incorrect placement of urethral catheter should be suspected. 4. A simple catheter irrigation and physical examination assessing the length of exposed catheter are often sufficient to diagnose the problem. If initial bedside assessment is inconclusive, imaging studies should be carried out to locate the position of Foley balloon and tip of catheter. Imaging studies are useful to document what has happened. 5. Intra-urethral Foley catheter balloon inflation can be prevented if transurethral catheter drainage is avoided altogether.

Consent for publication
All patients gave consent for publication of the Case report and any accompanying images.