Hypothesis / aims of study
Clean intermittent catheterizations (CIC) are one of the suggested treatments for patients with a disability to empty their bladder or a significant post void residual (PVR). These pathologies could be observed in cases of detrusor underactivity (DU), bladder outlet obstruction (BOO) or any kind of dysfunctional voiding. Regarding anatomical reasons, prostate enlargement and urethral stricture could lead to high PVR or urinary retention, while functional causes are more complex. One of the most studied patient groups are neurological patients with dysfunction of the lower urinary tract, known as neurogenic lower urinary tract dysfunction (NLUTD). NLUTD has been highlighted in patients with spinal cord injury (SCI) and Multiple Sclerosis (MS). In neuro-urological patients DU can be detected and in dependence with the level of neurological damage result in high PVR or retention, usually chronic, while low bladder compliance due to detrusor overactivity and detrusor-sphincter dyssynergia may lead to incontinence and obstructed voiding.
CIC as ideal treatment for neuro-urological patients has two main goals: bladder emptying and preserving low detrusor pressures in filling phase, protecting the upper urinary tract and reducing episodes of incontinence.
Although CIC is strongly recommended in neuro-urological cases, it remains a minimal invasive treatment with complications, mostly minor. Hence, there is a number of patients who discontinue CIC, endangering the proper function of both lower and upper urinary tract. Inevitably, they present in Emergency Departments with urinary tract infections (UTIs), constant urinary incontinence and even urosepsis or renal failure, in more severe cases.
The aim of our study was to investigate the reasons that lead neuro-urological patients to cease CIC treatment and suggest potential factors leading to this decision.
Study design, materials and methods
This is a prospective observational study including adult patients who visited the Neuro-urological and Urodynamics clinic of our Urology Department. Treatment with CIC was indicated in all patients, according to their previous urodynamic findings and they were adequately informed for the benefits and possible complications of their therapy, signing an appropriate consent form. Inclusion criteria were patients with MS and SCI able to perform self-catheterization after training by specialized staff. The catheters offered to all patients were hydrophile, pre-lubricated, containing Polyvinyl chloride (PVC) and ready for use. Exclusion criteria comprised the inability to perform self-catheterization, the use of less than 3 catheters per day and non-compliance with at least a 6 month follow-up examination.
At baseline, the Expanded Disability Status Scale (EDSS), the existence of a supportive environment and the residence distance from our hospital have been recorded. Moreover, treatment with anticholinergics, beta3-agonists or intradetrusor botulinum-A toxin (BOTOX-A) interventions has been documented.
All patients were scheduled for a three-months follow-up up to 3 years, evaluated with a visual analogue scale (VAS) about their satisfaction with CICs (0 for worst and 10 for the best opinion), while they were asked to report any complications during their therapy. In cases of dropout from treatment, the main reason was investigated and recorded. Patients were asked to report any visits to other centers for emergency or consultation reasons.
During the period of Covid-19 pandemic, follow-up was restricted to the means of phone calls for some patients, depending on their clinical situation and the health system availability.
All data has been collected and statistically analyzed using Numbers 11.0 for iOS.
Results
The study included 108 patients, 58 men and 50 women with a median age of 41 years (range: 19 – 60) and a median follow-up of 26 months (range: 6 – 60). The median number of used catheters were 5 (range: 3 – 6). 42 (38.9%) of patients had MS and 66 (61.1%) had SCI. All of them had neurological follow-up for their basic disease with a supportive environment. 45 (41.7%) of the total group were living near our medical center and 63 (58.3%) in a driving distance over an hour or in rural areas. Among those seeking pharmaceutical treatment for NLUTD, 18 (42.9%) patients with MS were on anticholinergics, 5 (11.9%) on mirabegron and 4 (9.5%) under BOTOX-A treatment. Regarding patients with SCI, 30 (45.5%) had anticholinergics medication, 8 (12.1%) used mirabegron and 14 (21.2%) had BOTOX-A therapy. Combination treatment was not reported in any patient. 20 (47.6%) MS patients had an EDSS 6 and 22 (52.4%) a scale >6. In the group of SCI, 52 (77.8%) patients were with EDDS >6 and 14 (21.2%) had 6.
At the first follow-up visit, 3 months after baseline, all patients came back without discontinuing treatment. 3 (2.8%) of them complaint about slight hematuria, resolved automatically and 1 (0.9%) had an uncomplicated UTI. None of them visited emergency departments or other health provider. The median VAS was 8 (range: 6 – 10).
After the first year of treatment, 102 (94.4%) patients continued their follow-up and 98 (96.1%) continued CIC. 1 (0.98%) episode of hematuria and 1 (0.98%) of UTI were recorded. Median VAS was 8 (range: 5 – 10). 4 followed-up patients stopped treatment due to their belief that it was incompatible with their physical condition. They had all MS with EDDS 6. 6 (5.6%) patients ceased their visits in favor of a closer center.
At the third year, 100 (92.6%) patients continued follow-up, with 2 more (1.9%) opting for a less distant hospital. 91 (91.0%) of them continued CIC and 9 (9%) of them dropped-out. 6 (66.7%) had MS with EDSS 6 and 3 (33.3%) SCI, needed to stop oral treatment due to side-effects. Hematuria was recorded in 2 (2.2%) cases and uncomplicated UTI in 1 (1.1%). Among those who stopped CICs, 5 (55.6%) visited emergency departments with complicated UTI requiring hospitalization. Median VAS was 7 (range: 5 – 10) for those continued treatment.
During pandemic, 98 (90.7%) patients had typical visits and 10 (9.3%) phone-call evaluation. Interestingly, all patients with phone-calls completed their 3-year follow-up, continuing CIC.
Interpretation of results
CIC is an essential treatment for neuro-urological patients, according to their urodynamic findings. However, it is not always easy for patients to perform CIC and consequently proper education and high-quality catheters are required. Our study demonstrated that EDSS may affect the decision to continue/discontinue CICs, especially in patients with MS and minor mobility problems. Also, side-effects of concomitant medication could lead to therapy termination. In any case, cease of CICs in NLUTD patients often causes severe complications, such as urosepsis. Our results showed distance from our center might have played a role in missing follow-up, but also pandemic did not discourage patients from visiting our hospital.
The short follow-up of our study could be regarded as a limitation, and is probably the main reason for high levels of patients’ adherence to CIC. However, one could argue that this could be attributed to their close follow-up, high-quality catheters and education. Another limitation could be that there is a scarcity of data regarding the physical history of the missing patients, as transitional care is not established in our health system.