Treatment of neurogenic bowel dysfunction using transanal irrigation: a multicenter Italian study.

STUDY DESIGN: Thirty-six patients with unsatisfactory treatment of neurogenic bowel dysfunctions (NBD) were enrolled from Spinal Units and Rehabilitation Centers in Italy. Treatment was for 3 weeks using a newly developed integrated system with an enema continence catheter for transanal irrigation (Peristeen, Coloplast A/S Kokkedal Denmark). OBJECTIVES: To evaluate the effects of Peristeen Anal Irrigation on NBD and patient quality of life (QoL). SETTING: Italy. METHODS: Lesion level, ambulatory status and hand functionality were determined in all patients. NBD symptoms and QoL were evaluated before and after treatment, using a specific questionnaire. Statistical analysis was performed using McNemar Test and Sign Test. RESULTS: Thirty-six patients were enrolled, and 32 patients completed the study. At the end of the treatment, 28.6% of patients reduced or eliminated their use of pharmaceuticals. Twenty-four patients became less dependent on their caregiver. There was a significant increase in patients' opinion of their intestinal functionality (P=0.001), QoL score (P=0.001) and their answers regarding their degree of satisfaction (P=0.001). A successful outcome was recorded for 68% of patients with fecal incontinence, and for 63% of patients with constipation. CONCLUSION: Peristeen Anal Irrigation is a simple therapeutic method for managing NBD and improving QoL. It should be considered as the treatment of choice for NBD, playing a role in the neurogenic bowel analogous to that of intermittent clean catheterization in bladder treatment.

Evaluation of an occupational therapy program for patients with spinal cord injury.

STUDY DESIGN: Clinical controlled trial. OBJECTIVES: To evaluate the effectiveness of an occupational therapy (OT) program combined with neuromotor rehabilitation, by assessing the degree of functional independence reached by patients with spinal cord injuries at first hospitalization. SETTINGS: Subjects selected from the Spinal Cord Unit of the Rehabilitation Institute of Montecatone (Imola, Italy). PARTICIPANTS: Thirty-six male patients below age 60, with complete paraplegia (ASIA-A) in thoracic-lumbar level, at first hospitalization. METHODS: Patients were divided into experimental and control groups. Subjects in the experimental group underwent neuromotor rehabilitation coupled with an OT program, whereas those in the control group followed neuromotor rehabilitation only. Increase in functional independence at discharge was evaluated by the Valutazione Funzionale Mielolesi (VFM) assessment scale. RESULTS: Patients in the experimental group showed a significant increase in the total VFM score, and in domains concerning transfers and wheelchair use. A significant improvement was observed in unmarried patients as compared to married ones. CONCLUSION: An OT service within a Spinal Cord Unit allows us to achieve a higher level of functional independence.

Trospium chloride in patients with neurogenic detrusor overactivity: is dose titration of benefit to the patients?

OBJECTIVE: To determine whether dose titration based on therapeutic response is superior to standard dosing of oral trospium chloride in patients with neurogenic detrusor overactivity and, moreover, to investigate the possible underlying causes of differences in efficacy at equal doses in some patients. PATIENTS AND METHODS: Using a double-blind approach, two groups (standard dose and adjustable dose) with a total of 80 patients were treated with trospium chloride coated tablets for a period of 3 - 5 weeks. Treatment duration and daily doses varied depending on change ofurodynamic parameters defined as therapeutic response. In Week 1, both groups started on 45 mg/day (3 x 15 mg). In the adjustable dose group, it was permissible to increase the daily dose to 90 or 135 mg/day depending on the urodynamic treatment response. In contrast, doses remained unchanged in the standard dose group although a need for dose adjustment had been recognized under the double-blind conditions. Therapeutic response was defined as improvement of at least two of the following three urodynamic parameters: bladder compliance 2 20 ml/cmH20, maximum cystometric capacity > 250 ml and maximum detrusor pressure < 40 cmH20. Changes in individual urodynamic parameters were defined as secondary efficacy variables. Primary and secondary parameters were assessed by comparing baseline values with those at the end of treatment. Therapeutic response was analyzed by using the Fisher-Yates test, and the Mann-Whitney U-test was used for secondary parameters. Trospium plasma concentration was measured to assess patient's compliance and as a tool to elucidate possible factors influencing treatment efficacy. Safety and tolerability were evaluated based on withdrawal rates and adverse events. RESULTS: Both dose groups had comparable baseline characteristics. Therapeutic response was achieved in 58% of patients in the adjustable dose group (ADG) and in 72% of those in the standard dose group (SDG, p -0.23). Clinically relevant increases in maximum cystometric capacity and bladder compliance were observed, and there was a clear decrease in detrusor pressure. After Day 7, the daily dose was increased in 52.8% of all patients in the adjustable dose group and (seemingly) in 32.5% of those of the standard dose group. Further dose escalation after Day 14 was assessed as necessary in 15% of the standard dose group and 22% of the adjustable dose group. The main changes in urodynamic parameters occurred during the first 7 days of treatment, but in some patients it takes a longer time. No statistically significant differences between plasma trospium chloride levels in the two dose groups were observed at any time, but increase of plasma concentration with higher doses became obvious when patients were differentiated to individual dose stages. In both groups, the most common treatment-related adverse event was dry mouth (ADG 35%, SDG 37%), which never led to discontinuation of treatment. Rates of other adverse events such as dry skin, dysopia, increased heart rate and gastrointestinal disorders were much lower. CONCLUSION: Generally, in patients with neurogenic detrusor overactivity daily doses of 45 mg trospium chloride can be considered as being the standard dose, and dose adjustment, e.g. due to increased body weight, might usually not be necessary. However, increased daily doses of up to 135 mg appear to be safe when prescribed in individual patients less responsive to the drug.

Study of the effectiveness of bronchial clearance in subjects with upper spinal cord injuries: examination of a rehabilitation programme involving mechanical insufflation and exsufflation.

STUDY DESIGN: Randomized controlled trial. OBJECTIVES: To establish whether the use of mechanical insufflation/exsufflation leads to a significant improve in tracheostomy subjects with upper spinal cord injuries (C1-C7), ASIA classification grade A and bronchial hyper secretion the following parameters: forced vital capacity (FVC), forced exspiratory volume on the first second (FEV1), FEV1/FVC, peak exspiratory flow (PEF), arterious pressure of O(2) (Pa O(2)), arterious pressure of CO(2) (Pa CO(2)), pH, saturation of O(2) (Sa O(2)). SETTING: Spinal Cord Unit, Montecatone Rehabilitation Institute, Imola, Italy. METHODS: The patients were split into two groups: the experimental group (EG) and the control group (CG). Each patient was given 10 treatments: the EG was given manual respiratory kinesitherapy associated with mechanical insufflation/exsufflation with inhale and exhale pressure between 15 cm H(2)O and 45 cm H(2)O, while the CG was only given manual kinesitherapy. The treatment sessions covered the necessary amount of time in order to achieve sufficient clearance. The study has been approved by the local ethic committee. The patients were informed before being enrolled in that study and gave their written consent. RESULTS: At the end of the treatment associated with the mechanical insufflation/exsufflation, the EG showed a significant increase in FVC, FEV1 and PEF, although it was not possible to compare the latter with the CG. The other parameters were also subject to variations, although not statistically significant. The CG did not show signs of any significant change. CONCLUSION: The use of mechanical insufflation/exsufflation in subjects with the aforementioned characteristics is shown to be an effective adjunct to manual respiratory kinesitherapy, since it makes it possible to achieve adequate bronco-pulmonary clearance, even removing thick, deep secretions and making it possible to insufflate any areas affected by atelectasis.

Neuro-urologic disorders in the patient with spinal cord injury after vertebral fracture: progress in the uro-rehabilitative approach between diagnosis and treatment.

The treatment of urinary disorders in post-traumatic myelic pathology must necessarily include the physiatrist involved in the rehabilitation of the patient with spinal cord injury. The approach to the disability consequent to a spinal cord injury, in fact, cannot be separated from the rehabilitative treatment of bladder-sphincter deficit that always accompanies the clinical course of this pathology: neurourologic disorders always negatively influence the quality of the person's life, they are the cause of severe complications, and, at times, they are resistant to any combined medical-surgical-rehabilitative treatment.

[Lipids in enteral nutrition: does an optimal ratio between omega-6 and omega-3 exist?]. / I lipidi in nutrizione enterale: esiste un rapporto ottimale omega-6/omega-3?

The ratio between PUFA omega-6 and omega-3 is 3:1 in the unweaned, 5:1 in the young man, 5-10:1 in the adult. The PUFA omega-6 prevail over omega-3 because of elongation and desaturation processes. Linoleic acid is the beginning of the omega-6 series, a-linolenic acid of the omega-3 series. Both acids give rise to PUFA which must be introduced with diet because the human race is not able to synthetize. They represent the 2-6% of total daily caloric intake and correspond about to 10 g every day according to LARN 1986-1987. During some diseases (after surgery, trauma, sepsis, etc.) their need increases until 25-50 g every day, so it is necessary a proper enteral nutrition (EN). For this reason the bromatological composition of diets for EN must respect the physiological ratio between omega-6 and omega-3 PUFA. The composition of 37 diets for EN was examined and it was found that 7 (18%) have a proper ratio between the two series of PUFA. Twenty-three (62%) do not signal any ratio, two have 6:1, two 4.5:1, in three the ratio is in favour of omega-3. Then the concentration of linoleic and alfa-linolenic acid was examined and it was found that 24 (64%) diets signal the concentration of linoleic acid, 10 (27%) of both acids, two have no data about and only one diet reports the concentration of alfa-linolenic acid. A more exact formulation of PUFA into the composition of EN diets is suggested because PUFA are now recognized to play an important role in the fields of inflammation and immunity.