A Prospective, Randomized, Controlled Study of a Suspension Positioning System Used With Elderly Bedridden Patients With Neurogenic Fecal Incontinence

Elderly patients with acute neurological impairment are prone to severe disability, fecal incontinence (FI), and resultant complications. A suspension positioning system (SPS), based on the orthopedic suspension traction system commonly used for conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture, was developed to facilitate FI management in patients immobilized secondary to an acute neurological condition.   To evaluate the effectiveness and safety of the system, a prospective, randomized, controlled study was conducted between October 2009 and July 2012. Two hundred (200) elderly, bedridden, hospitalized patients with acute, nonchronic neurological impairment were randomly assigned to receive routine FI nursing care (ie, individualized dietary modification, psychological support, health education, and social support for caregivers and family members [control group]) or routine incontinence care plus the SPS (experimental group) during the day. Rates of perianal fecal contamination, skin breakdown, incontinence-associated dermatitis, pressure ulcer development, and lower urinary tract infection (LUTI) were significantly lower in the SPS than in the control group (P <0.05). Length of hospitalization and costs of care were also lower in the SPS group (P <0.05). Patient quality-of-life (QoL) and FI QoL scores were similar at baseline but significantly higher (better) at the 6-month follow-up interview in the SPS than in the control group (P <0.05). In this study, the rate of FI-associated morbidities was lower and 6-month patient QoL scores were higher in the SPS than in the control group. No adverse events were observed, and all patients completed the study. Further clinical studies are needed to examine the long-term effects of SPS use among neurologically impaired FI patients.

Fecal incontinence (FI) is defined as permanent or temporary impairment in controlling defecation that results in complete or partial involuntary leakage of bowel contents, including flatus, liquid stool elements, mucus, and solid feces.¹ In 1995, the Wisconsin Family Health Survey² of 6,959 persons in 2,570 households reported FI affected approximately 2.2% of community residents, 30% of whom were >65 years of age and 63% of whom were women.² A British shire-wide census in 1990 that surveyed 6,079 residents >64 years of age from 241 hospitals, senior residences, and nursing homes found up to 44% of respondents were incontinent of feces, urine, or both.³ FI may be confounded by constipation or diarrhea and also may occur independently or concomitantly with urinary incontinence.

  Any factor impairing normal defecation reflex can cause FI; in most cases, multiple deficiencies of interrelated mechanisms are involved. The etiology of FI is generally classified as idiopathic or acquired and varies by age group. FI develops as a result of chronic constipation in children (up to 84% of cases),⁴ prior anorectal surgery or underlying bowel disorders in men (2%−20%),⁵ immediate or delayed pelvic floor injury from childbirth in women (~18%),⁶ and age-related muscle atrophy and nerve dysfunction in the elderly (6.4%).⁷ Acute or chronic neurological disorders are frequently (50%−70%) accompanied by FI include cerebrovascular disease, Parkinson’s disease, multiple sclerosis, spinal injury, diabetic neuropathy, and other types of central or peripheral nerve disorders.⁸ A retrospective, observational study showed FI is also common after acute brain injury (68%) and leads patients to seek inpatient rehabilitation.⁹

  According to a community-based registry study,¹⁰ FI reduces all aspects of a patient’s physical and psychosocial functions, thus impairing quality of life (QoL); 3 major consequences of FI include irritation, maceration, and rashes of the perianal skin; urogenital tract infections; and decubitus (pressure) ulcers. These unfavorable conditions may humiliate and depress the patient and prevent enjoyment of normal activities.¹⁰ Moreover, community-based and hospital-based studies^10,11 have shown if FI occurs in an inpatient, it will unavoidably increase the amount of nursing care required, weaken the patient’s resistance to nosocomial infections, prolong the duration of hospitalization, and, consequently, place a heavy burden on the public health care system.

  In 2010, the Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee¹² indicated FI-associated symptoms require appropriate medical care because they might worsen over time depending on the cause and complexity of the FI. Normally, FI is controlled through conservative measures, such as diet modification, drug treatment, anal irrigation, biofeedback, and sphincter exercises. A community-based survey¹³ was conducted among 189 persons, who were recruited before their enrollment in a clinical trial evaluating the therapeutic effects of dietary fiber on mild FI. The results suggested it is essential to keep the perianal area hygienic by using disposable incontinence products, such as diapers or nappies. However, the Cochrane Incontinence Group Specialised Register study¹⁴ systemically reviewing randomized or quasi-randomized trials found such conservative measures are not feasible or sufficiently effective for inpatients suffering from FI secondary to neurological impairment, because changing adult diapers was labor-consuming, not cost-effective, and less acceptable in these temporarily or permanently disabled patients.

  To address the need for FI care, especially skin hygiene and integrity for patients with neurological impairment in a cost-effective manner, the current authors developed a suspension positioning system (SPS) to more easily turn the patient. This SPS is based on the orthopedic suspension traction system commonly used for the conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture. The SPS consists of a suspending device (see Figure 1a) and cushioned belts (see Figure 1b). The suspending device comprises 4 vertical support rods and 4 horizontal connecting rods on the top, which form a cross-frame. Rolling wheels slide along the top cross-frame and suspend the cushioned belts with hooks. Each cushioned belt is composed of a cotton cushion and 4 string belts. The outer layer of the string belt is made of compact, wear-resistant synthetic fabric. The inner layer is made of soft, skin-friendly cloth. The inferior end of a string belt (260 cm × 16 cm for the thigh, 260 cm × 14 cm for the lower leg) connects to a cushion (65 cm × 36 cm for the thigh, 52 cm × 34 cm for the lower leg) bilaterally, and the superior end attaches to another string belt with Velcro®. The connected string belts are hooked onto the frame through the top holes. A 50-cm drainage hole underlying absorbent continence pads is located at the center of the thigh cushion to allow nursing care of the perineal area.

  To evaluate the effectiveness and safety of continence care using the SPS, a 6-month, single-institute, prospective, randomized, controlled study was conducted among elderly, bedridden patients with acute neurological impairment and FI. Specifically, this study assessed whether SPS use could reduce the nursing burden, support the cost-effectiveness of continence care, and improve the health status of FI patients by minimizing FI-associated morbidities (eg, skin breakdown and urinary tract infection).

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).

  Protocol.
  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.

Two hundred patients participated; 100 in the control and 100 in the experimental group. The etiologies of neurological impairment included cerebral infarction (118), traumatic or spontaneous cerebral hemorrhage (66), intracranial infection (9), myelitis (4), and brain tumor (3). The 2 groups were comparable with respect to age, gender, body mass index, underlying neurological impairment, level of consciousness, FI severity, stool consistency, concomitant medical conditions, and previous history of abdominal/pelvic and perianal surgery (P >0.05) (see Table 2). No procedure-related adverse events, except for mild, transient leg discomfort, were reported by patients receiving additional incontinence care using the SPS.

  Perianal fecal contamination occurred less frequently in the experimental group than in the control group (4 [4.0%] versus 89 [89.0%], P <0.001) (see Table 3). The overall frequency of skin breakdown also was significantly lower in the experimental group than in the control group (11 [11.0%] versus 39 [39.0%], P <0.001). The experimental group exhibited a lower rate of mild (grade I) local skin breakdown compared to the control group (6 [6.0%] versus 23 [23.0%], P = 0.001), while the two groups had similar rates of moderate (grade II, 5 [5.0%] versus 11 [11.0%], P = 0.191) and severe (grade III, 0.0% versus 5 [5.0%], P = 0.059) local skin breakdowns. However, skin breakdown was less frequently refractory to nursing care in the experimental group than in the control group (overall, 4 [4.0%] versus 25 [25.0%], P < 0.001; grade I, 2 [2.0%] versus 15 [15.0%], P = 0.002; grade II, 2 [2.0%] versus 6 [6.0%], P = 0.279; grade III, 0.0% versus 4 [4.0%], P = 0.121).

  Urinary tract morbidities usually occurred 7 to 15 days after admission. LUTI occurred less frequently in the experimental group than in the control group (14 [14.0%] versus 40 [40.0%], P <0.001). The experimental group also had smaller percentages of patients with bacteriuria (8 [8.0%] versus 32 [32.0%], P <0.001) or leucouria (7 [7.0%] versus 40 [40.0%], P < 0.001) than the control group. LUTI symptoms were less frequently reported in the experimental group compared to the control group (9, [9.0%] versus 43 [43.0%], P <0.001). Moreover, the experimental group had lower frequencies of refractory LUTI (6 [6.0%] versus 28 [28.0%], P <0.001), refractory bacteriuria (4 [4.0%] versus 18 [18.0%], P = 0.003), refractory leucouria (3 [33.0%] versus 29 [29.0%], P <0.001), and refractory LUTI symptoms (5 [5.0%] versus 35 [35.0%], P <0.001) than the control group.

  The experimental group required less time (0.7 ± 0.2 hours versus 4.2 ± 0.8 hours, P <0.001) and fewer consumable costs (10.0 ± 0.9 CNY versus 78.5 ± 10.1 CNY, P <0.001; 1 CNY = 0.16 USD) for daily continence care compared to the control group. Use of the positioning equipment was associated with shorter hospitalization stays (38.5 ± 8.4 days versus 55.6 ± 11.8 days, P <0.001) and lower overall medical costs (4,786 ± 428 CNY versus 6,014 ± 502 CNY, P <0.001), excluding labor costs; daily medical costs were highly variable.

  No patients were lost to follow-up.

  The follow-up psychometric evaluation results are shown in Table 4. The two groups had similar QoL scores in all aspects of the SF-36 questionnaire at baseline (P >0.05). At the 6-month follow-up telephone interview, the experimental group exhibited better QoL scores than the control group in all aspects of the SF-36 questionnaire, including vitality (76.5 ± 18.8 versus 64.6 ± 18.5, P <0.001), physical functioning (89.1 ± 15.7 versus 81.2 ± 11.5, P <0.001), general health perceptions (69.7 ± 19.6 versus 54.4 ± 18.2, P <0.001), physical functioning (73.7 ± 20.4 versus 66.3 ± 22.5, P = 0.016), emotional functioning (79.4 ± 16.7 versus 65.6 ± 18.5, P <0.001), social functioning (82.2 ± 12.9 versus 74.4 ± 15.6, P <0.001), and mental health (74.1 ± 15.5 versus. 62.2 ± 13.4, P < 0.001), except bodily pain (77.5 ± 19.3 versus 72.4 ± 17.4, P = 0.051). The experimental group also had better continence-related QoL scores than the control group in terms of lifestyle (3.0 ± 0.8 versus 2.4 ± 0.9, P <0.001), coping/behavior (3.1 ± 0.9 versus 2.5 ± 0.7, P < 0 .001), and embarrassment (2.4 ± 0.6 versus 2.1 ± 0.7, P = 0.001). The 2 groups exhibited similar psychometric outcomes regarding depression/self-perception (2.7 ± 0.9 versus 2.6 ± 0.6, P = 0.356).

To the best of the authors’ knowledge, this is the first prospective, randomized, controlled study to assess the use of suspension positioning equipment on nursing and patient QoL outcomes of elderly, bedridden, patients suffering from FI secondary to acute neurological impairment. Use of the SPS improved continence care outcomes, reduced the amount of nursing care required, and resulted in better QoL scores.

  Age is a major risk factor for neurological impairment. A previous geriatric facility-based study²² involving 1,162 residents in 18 Czech Republic institutions reported older people suffering from consciousness disorders were at a very high risk (up to 96%) for FI. A pooled analysis²³ of 21 observational studies and 4 randomized, controlled trials between 1990 and 2007 demonstrated FI significantly disabled neurological patients and disrupted their normal daily activities.

  Adverse effects of FI are likely to be underestimated in patients who live in a community and suffer from chronic neurological impairment such as dementia. Continence care is critical for the well-being of older people who experience neurological problems. The results of a 2011 community-based survey¹³ of 189 participants indicated routine continence care, including the use of disposable, absorbent products, should be modified according to the FI patient’s needs. After reviewing inhospital FI care practice, von Samson²⁴ noted conventional continence care was costly, burdensome, and inefficient.

  In 2006, a secondary analysis of a prospective, multicenter, open-label, quasi-experimental study conducted among 16 randomly selected US nursing homes reported local perianal skin breakdown occurred after a median of 13 (range 6–42) days in 4.6% of 981 institutionalized residents. In 3.4% cases, skin breakdown was determined to be incontinence-associated dermatitis, primarily due to contamination.²⁵ Moisture from urine, stool, perspiration, or other body fluid drainage leads to friction and irritates delicate perianal skin. Moreover, frequent contamination requires frequent skin cleansing, and repeated contact with cleansing agents is known to weaken the protective effect of the skin.¹³ As shown in the current data, use of the SPS decreased the likelihood of perianal fecal contamination and mild skin breakdown, outcomes not achieved through the use of absorbent products alone. Although the frequency of moderate and severe skin breakdowns was only slightly lower in the experimental group than in the control group, these statistically insignificant differences may be attributed to the fact that only a few patients experienced moderate or severe skin breakdown.

  An institute-based study²⁶ in 1990 reported incontinent elderly people developed LUTIs almost 3 times as frequently as their fecally continent counterparts. Perianal fecal contamination is believed to be the primary cause of these infections, because most microbial isolates from the urine samples are normal residents of the gastrointestinal tract. Immobilized, confused patients, such as the neurologically impaired patients in this study, are at an even higher risk of LUTIs during the course of hospitalization, as shown by the current results. Multicenter, prospective surveillance among nursing home residents²⁷ shows concurrent urinary incontinence with FI (found in >40% of current patients) is another risk factor for LUTIs among institutionalized residents. These nosocomial infections will inevitably compromise the well-being of patients, prolong their hospitalization, and, consequently, increase nursing workload and medical costs. The authors observed the use of the SPS minimized the risk of LUTI, possibly by reducing the frequency of fecal contamination.

  A prospective, observational study²⁸ involving 29 consecutive patients with FI with or without urinary incontinence admitted to 2 subacute care units of a metropolitan hospital in 2005 showed FI was associated with substantial direct medical and indirect nonmedical economic costs, with staffing consuming the major share. In this study, incontinence care was shown to be the primary nursing care burden in hospitalized and institutionalized individuals. In the present study, continence care in the control group took the nursing staff almost 50% of the working day and required nearly 8 times more consumable products than the corresponding care in the experimental group.

  FI greatly diminishes both the physical and mental health of a patient and adversely impacts personal, social, and work life. In 2010, a secondary analysis²⁹ was performed of prospectively collected data for a clinical trial evaluating fiber supplementation for treating FI. The analysis demonstrated possible emotional responses to FI include stress, anxiety, exhaustion, humiliation, loss of self-esteem and desire for life, depression, isolation, frustration, and embarrassment. The physiological benefits of using the SPS, such as reduction in fecal contamination and LUTI symptoms, can alleviate the physical and mental suffering of a patient.

  In addition to providing continence care, this equipment offers rehabilitation therapy. The combined participation of the patient, caregiver, continence nurse, and rehabilitation therapist in using the positioning equipment may help support the patient psychologically and socially, as shown by the present study results. Specifically, use of the SPS was associated with better overall and continence-related QoL scores, except for bodily pain and depression/self-perception. However, in these patients, lack of improvement in the bodily pain and depression/self-perception categories also may be related to the underlying neurological impairment, rather than the secondary FI.

  Lease of the SPS costs $1.60 USD per day, which may increase to $4.30 USD per day if staff is paid to operate the equipment as determined by the original charge of traction care. The equipment is easy to assemble and use. Home caregivers can be trained to operate it, further increasing its accessibility and reducing nursing-care costs.

 Because this study was an open-label trial, it was subject to placebo effect and investigator bias, especially in terms of psychometric evaluation. Also, because patients were not stratified by severity of neurological impairment, indwelling urethral catheterization, or bladder irrigation, these factors may have confounded FI-associated morbidities and FI nursing outcomes. Another consideration is outcomes at 6 months may have differed among patients who ceased using the SPS after discharge as compared to those who continued its use at home. In addition, a 6-month, short-term follow-up is insufficient for the evaluation of chronic conditions such as FI.

Use of the SPS significantly reduced the incidence of perianal fecal contamination and skin breakdown in elderly patients hospitalized for acute neurological impairment with complicating FI. Additional benefits of using this equipment included reductions in LUTI occurrence, nursing care burden, duration of hospitalization, and nursing/medical costs, as well as improved overall and continence-related short-term QoL scores. A long-term follow-up study conducted by independent investigators is required to validate the usefulness and cost effectiveness of the SPS.

This work was supported by a research grant from Fujian Provincial Natural Scientific Foundation (#2011J01395).

Dr. Su is Professor of Nursing, Department of Neurology; Dr. SQ Lin is an attending physician, Department of Anesthesiology; Dr. zhuo is nurse-in-charge, Department of Neurology; Dr. Liu is nurse-in-charge, Department of Renal Medicine; Dr. A Lin is Professor of Nursing, Department of Orthopedics; and Dr. XR Lin is Professor of Nursing, Department of Neurology, Mindong Hospital, Fujian Medical University, Ningde, China. Please address correspondence to: Mei-Yin Su, MD, Department of Neurology, Mindong Hospital, Fujian Medical University, 89 Heshan Road, Ninge 355000, China; email: 19882755@qq.com.