The study protocol was approved by the Institutional Review Board at Mindong Hospital affiliated with Fujian Medical University, in accordance with the latest version of the Declaration of Helsinki.
Patients. A total of 305 patients was hospitalized at Mindong Hospital between October 2009 and July 2012 due to acute neurological impairment, including acute cerebral infarction, cerebral hemorrhage, intracranial infection, myelitis, or acute complications of a brain tumor. Upon admission, 225 of the 305 patients (73.8%) had concomitant FI. These patients were further screened for study eligibility. Inclusion criteria for this study stipulated: age 60 years; conscious, alert, and in a stable neurological condition; presence of neurogenic FI as determined by anorectal manometry; daily defecation frequency of >8 and a single stool volume (excluding infectious diarrhea) of 80–150 mL; unable to perform daily off-bed activities; and expected to survive the underlying acute neurological impairment and able to complete a 6-month follow-up questionnaire by phone interview. Patients were excluded from this study if they had a preexisting chronic neurological condition; exhibited dementia; were unconscious, delirious, or uncooperative with nursing care; had any serious cerebral, cardiopulmonary, hepatorenal, or other life-threatening comorbidity; had complicating acute gastrointestinal infections or obstructions; or refused participation.
After eligibility screening, independent research nurses interviewed patients at the bedside and reviewed medical/nursing charts to document baseline demographic and clinical characteristics including age, gender, body mass index, level of consciousness, underlying acute neurological impairment, and concomitant medical/surgical conditions. FI severity was assessed using Park’s incontinence score (see Table 1a).15 The volume, color, and consistency of stool were described according to the Bristol stool scale (see Table 1b).16 The cleanliness and integrity of the perianal skin were classified using the Shea pressure ulcer classification (see Table 1c).17 All patients gave informed consent in writing before participating in this study.
Eligible patients were consecutively, equally, and randomly assigned by a computer-generated random number table to either routine FI nursing care (control group) or additional incontinence care with the SPS (experimental group) (see Figure 2).
Incontinence care. Routine nursing approaches consisted of providing individualized dietary modification (usually by increasing dietary fiber consumption), psychological support, health education, and social support for caregivers and family members. Patients in both groups received identical baseline continence care, including maintenance of clean, dry bedding; timely replacement of contaminated clothes and bed sheets; immediate removal of residual fecal material using sanitized moistened napkins; and regular cleaning of the perianal area. Denuded skin was cleaned with warm sterile water and dried. Disposable, absorbent continence pads (CoCo Household Chemicals Co, Ltd, Shanghai, China) were used in all patients with incontinence. They were replaced by nurses as needed. All patients were instructed to drink excessive water (1.5−2.0 L/day) to prevent urinary tract infection. Indwelling urethral catheterization was performed in patients with refractory urinary retention. Bladder irrigation was performed in patients with indwelling urethral catheters if obstruction was suspected. Patients were discharged, as ordered by the neurologist, when they were stable and required no further inpatient treatment for their underlying neurological condition.
Use of SPS. The parameters and time schedule for using the SPS were optimized in a preliminary study with healthy volunteers. Subsequently, independent nursing therapists were trained and assisted by the research nurses to operate the SPS in the present study. Patients were positioned supine with the head elevated 15˚ to 30˚. A thigh cushion held the lower limb from the ischium to the superior patellar margin, while a lower leg cushion held the calf, heel, and sole. Both legs were elevated to suspend the perineal area 45˚ to 65˚ (see Figure 3) above the bed surface. The angle between the lower leg and thigh was adjusted for patient comfort. The buttocks were cushioned with absorbent pads, which were frequently replaced to keep the perianal area clean. The SPS was used daily from 08:00 to 20:00 throughout hospitalization. Routine continence care was provided from 20:00 to 08:00. The patient’s position was changed on demand or at 2-hour intervals. The lower limb joints were actively or passively moved, and the cushioned pads under the back were readjusted on demand or at 2-hour intervals. All patients in the experimental group had free access to the SPS both inside and outside the hospital (eg, at home or in a nursing facility) and as instructed over a telephone hotline or by onsite nursing staff. The nursing therapist instructed caregivers in the operation of the SPS in the hospital and at home after hospital discharge. If needed, caregivers could obtain assistance through the research nurse hotline.
Outcome measures and variables. All inhospital data were collected at the beginning of the night shift by independent research nurses blinded to the patient’s FI care assignment using predefined study diaries. Independent single-blinded research nurses examined patients for the presence of incontinence-associated dermatitis every 2 hours, as recommended in a review by Gray.18 Skin breakdown was rated on a daily basis using the Shea classification of pressure ulcers — refractory skin breakdown referred to any breakdown failing conservative treatment and requiring surgical intervention.17 Clean, midstream urine samples (retained in the urinary bladder for at least 4–6 hours) were tested by the routine urine sediment test and microbiological culture on a weekly basis. For patients with an indwelling urethral catheter, the catheter was disinfected and a sterile needled syringe was used to aspirate the urine sample. Further data storage and analysis were performed by independent biostatisticians.
Lower urinary tract infection (LUTI) was defined as the presence of bacteriuria (>104 or >105 colony forming units [cfu]/mL urine for a patient without or with an indwelling catheter, respectively) in the presence of LUTI symptoms (frequent or urgent urination and dysuria). Leucouria was defined as the presence of white blood cells in the urine sample (>5 cells per high-power field [HPF] for a fresh urine sample, >400,000 cells/HPF for a 1-hour fresh urine sample, or >1,000,000 cells/HPF for a 24-hour urine sample) in the absence of LUTI symptoms. Refractory LUTI was defined as the recurrence of LUTI symptoms after empirical antimicrobial treatment. Cost-effectiveness analyses included the costs and time of daily continence care documented on nursing charts and bills, consumable costs, duration of hospitalization, and overall medical costs.
Survey instruments. The 36-item Short Form (SF-36) Health Survey19 and the 29-item Fecal Incontinence Quality of Life Scale (FIQLS)20,21 were administered during bedside consultation at the time of study enrollment. A second team of independent research nurses, blinded to the patients’ FI care group, re-administered the surveys by phone interview 6 months after the patient was discharged from the hospital. These questionnaires were used to evaluate patients’ overall and continence-related QoL.
The SF-36 is the gold standard questionnaire for measuring the overall health status of an individual, the burden of a disease/medical condition, and the cost-effectiveness of a treatment modality.17 The SF-36 questionnaire consists of 8 sections: vitality, physical health, bodily pain, general health perceptions, physical functioning, emotional functioning, social functioning, and mental health. Each section carries equal weight, and the maximum total score is 100 points. A higher SF-36 score suggests a better general health status and QoL.
The FIQLS is a QoL scale specifically developed for the psychometric evaluation of FI patients. It has been shown to be reliable, valid, and to correlate well with SF-36 outcomes.20,21 The FIQLS evaluates 4 psychometric parameters: lifestyle (10 items), coping/behavior (9 items), depression/self-perception (7 items), and embarrassment (3 items). Each item is scored from 1 to 4 points, with a higher score indicating a better continence-related QoL.
Statistical analysis. The statistical software package SPSS 15.0 (SPSS Inc, Chicago, IL) was used for data entry and statistical analysis. Continuous data were expressed as the mean ± SD and compared using Student’s t-test. Categorical data were expressed as n (%) and compared using Fisher’s exact test. Ordered categorical data were compared using the Wilcoxon signed-rank test. A P value <0.05 was considered statistically significant.