How reproducible is the cardioinhibitory response to carotid sinus massage in fallers?

AIMS: To ascertain the reproducibility of the cardioinhibitory subtype of carotid sinus hypersensitivity (CICSH) in fallers. METHODS AND RESULTS: One hundred and seventy-five subjects with CICSH and unexplained or recurrent falls were randomized to pacemaker implantation or control. Sixty-four control subjects (61% female, mean age 71.8 years, median 2 falls in the previous year) completed one-year follow-up and had carotid sinus massage (CSM) performed on 4 occasions (twice before randomization, at 6 months and 1 year following randomization). CSM was performed sequentially on the right and then left sides, initially supine and then upright at 70 degrees head-up tilt by the same investigator. On each occasion CSM was discontinued once CICSH was demonstrated. CICSH was demonstrated on 82% of occasions, 75% on right CSM and 77% whilst the subject was supine. Before randomization, and at 6 months and 1 year, 91%, 67%, and 70% of subjects had reproducible CICSH respectively. Half had CICSH on all 4 occasions. Only 17% had a consistent response on the same side in the same position. CONCLUSIONS: In the majority of subjects CICSH is reproducible and this is more likely shortly after the initial response. However the cardioinhibitory response to CSM is inconsistent both in side elicited and subject position.

Complications of carotid sinus massage--a prospective series of older patients.

BACKGROUND: there is a causal association between carotid sinus hypersensitivity, falls and syncope in elderly subjects. Neurological complications during carotid sinus massage have been reported in case studies and two retrospective series. Our aim was prospectively to ascertain the incidence of complications occurring after carotid sinus massage performed for diagnostic purposes in a consecutive series of patients. METHODS: 1000 consecutive subjects aged 50 years or over who attended the accident and emergency department with syncope or 'unexplained' falls had carotid sinus massage. Carotid sinus massage was performed for 5 s on the right and then left sides both supine and upright (70 degrees head-up tilt) with continuous heart rate and phasic blood pressure recording. Contraindications to carotid sinus massage were the presence of a carotid bruit, recent history of stroke or myocardial infarction or previous ventricular tachyarrhythmia. RESULTS: complications occurred in nine patients immediately after cessation of carotid sinus massage. Eight had transient neurological complications possibly attributable to carotid sinus massage: visual disturbance, 'pins and needles' and sensation of finger numbness in two cases each, leg weakness in one and sensation of 'being drunk' in one. All transient complications resolved within 24 h. In one patient mild weakness of the right hand persisted. CONCLUSIONS: no subjects had cardiac complications and 1% had possible neurological symptoms, which resolved in most cases. Persistent neurological complications are uncommon, occurring in 1:1000 patients (0.1%) or 1: 3805 episodes of carotid sinus massage (0.03%).

Diagnosis of carotid sinus hypersensitivity in older adults: carotid sinus massage in the upright position is essential.

OBJECTIVE: To assess the diagnostic value of supine and upright carotid sinus massage in elderly patients. DESIGN: Prospective controlled cohort study. SETTING: Three inner city accident and emergency departments and a dedicated syncope facility. PATIENTS: 1375 consecutive patients aged > 55 years presenting with unexplained syncope and drop attacks; 25 healthy controls. INTERVENTIONS: Bilateral supine carotid sinus massage, repeated in the 70 degrees head up tilt position if the initial supine test was not diagnostic of cardioinhibitory and mixed carotid sinus hypersensitivity. MAIN OUTCOME MEASURES: Diagnosis of cardioinhibitory or mixed carotid sinus hypersensitivity; clinical characteristics of supine v upright positive groups. RESULTS: 226 patients were excluded for contraindications to carotid sinus massage. Of 1149 patients undergoing massage, 223 (19%) had cardioinhibitory or mixed carotid sinus hypersensitivity; 70 (31%) of these had a positive response to massage with head up tilt following negative supine massage (95% confidence interval, 25.3% to 37.5%). None of the healthy controls showed carotid sinus hypersensitivity on erect or supine massage. The initially positive supine test had 74% specificity and 100% sensitivity; these were both 100% for the upright positive test. The clinical characteristics of the supine v upright positive subgroups were similar. CONCLUSIONS: The diagnosis of carotid sinus hypersensitivity amenable to treatment by pacing may be missed in one third of cases if only supine massage is performed. Massage should be done routinely in the head up tilt position if the initial supine test is negative.

Pelvic floor electrical stimulation for genuine stress incontinence: who will benefit and when?

This study sought to determine the characteristics of women in whom pelvic floor electrical stimulation will reduce stress urinary incontinence. It also evaluates how long electrical stimulation should be used before significant improvements are seen in clinical outcomes. Subjects with genuine stress incontinence were enrolled into a multicenter non-randomized trial. They used electrical stimulation for 15 minutes twice daily or every other day for 20 weeks. At the end of 20 weeks, those with a 50% reduction in leakage episodes on voiding diary ('responders') were compared with those who did not show a 50% reduction ('non-responders'). Thirty-one subjects were enrolled and 28 completed the study. After the treatment period, 19 subjects were defined as responders and 9 as non-responders. There were no significant differences between the two groups in baseline demographics (e.g. age, parity, largest birth weight etc.) other than body mass index (greater in nonresponders). Significant subjective and objective improvements were noted among responders by 10 and 14 weeks, respectively. Compliance was higher in responders during weeks 12-15 of the study (P=0.05). It was concluded that a minimum of 14 weeks of pelvic floor stimulation was necessary before significant objective improvements were seen. Body mass index and patient compliance may affect success.

Pelvic floor electrical stimulation for the treatment of urge and mixed urinary incontinence in women.

OBJECTIVES: To determine the efficacy of daily or every-other-day electrical stimulation in treating detrusor instability (urge) or urge plus genuine stress (mixed) urinary incontinence in women. METHODS: A multicenter, prospective, nonrandomized study enrolled subjects with urge and mixed urinary incontinence assigned to daily or every-other-day treatments (15 minutes twice daily) using pelvic floor stimulation. Outcome measures assessed were (1) leakage episodes, nocturnal episodes, voiding frequency, total voids, and pad count, and (2) patient subjective assessment and quality of life. RESULTS: Seventy-two subjects were enrolled. Sixty-eight subjects completed the 20-week protocol: 33 treated daily and 35 treated every other day. The entire study group (n = 68) experienced a significant decrease in total leaks (P < 0.001), nocturnal episodes (P = 0.001), pad count (P = 0.002), and total voids (P = 0.003) and on visual analog scales. Sixty-nine percent (n = 46) of subjects with urge or mixed incontinence were cured or improved by at least 50%, with 28% (n = 19) being cured. There were no significant differences between daily and every-other-day users. Nonresponse was correlated with number of previous therapies (P < 0.001) and number of vaginal deliveries (P = 0.007). Overall, subjects were 93% compliant with device use, and 72% (n = 47) were satisfied with the therapy. CONCLUSIONS: Twenty weeks of pelvic floor electrical stimulation therapy is effective in treating urge and mixed urinary incontinence, regardless of daily or every-other-day treatments.

Pelvic floor electrical stimulation: a comparison of daily and every-other-day therapy for genuine stress incontinence.

OBJECTIVES: To compare the effectiveness of daily and every-other-day electrical stimulation in treating genuine stress incontinence. METHODS: Subjects with genuine stress incontinence were enrolled in a multicenter, prospective, nonrandomized study and underwent daily or every-other-day pelvic floor stimulation treatments for 15 minutes twice a day. Outcome measures assessed were (1) leakage episodes and pad count; (2) leakage amount, and (3) subject subjective assessment and quality of life. Thirteen subjects treated daily and 15 treated every other day completed the 20-week protocol. One-year follow-up data were available for 21 subjects. RESULTS: No significant differences in primary outcome variables were found between the groups. Subjects treated every other day had significant decreases in total leakage episodes (P = 0.04), pad count (P = 0.04), total voids (P = 0.02), and visual analog scale scores, with stress incontinence cured or improved by 50% in 73% (n = 11). Subjects treated every day had significant decreases in urge episodes (P = 0.03), pad count (P = 0.05), and visual analog scale scores, with 62% (n = 8) cured or improved by 50%. Compliance was higher for subjects treated every other day (P = 0.05). Satisfaction with therapy was 75% (n = 10) for daily treatment and 77% (n = 12) for every-other-day treatment. At 1 year, 70% (n = 7) of subjects who continued device use maintained their cure or improvement status. CONCLUSIONS: Both daily and every-other-day therapy with pelvic floor electrical stimulation are effective in treating genuine stress incontinence. Subjects who continue device use maintain a higher curve or improvement rate.

Pelvic floor electrical stimulation in the treatment of genuine stress incontinence: a multicenter, placebo-controlled trial.

OBJECTIVE: Our purpose was to determine the efficacy of transvaginal electrical stimulation in treating genuine stress incontinence. STUDY DESIGN: This was a multicenter, prospective, randomized, double-blind, placebo-controlled 15-week trial comparing the use of an active pelvic floor stimulator with a sham device. Thirty-five women used an active unit and 17 control subjects used sham devices. Weekly and daily voiding diaries were recorded throughout the trial. Urodynamic testing, including pad test and subtracted cystometry, was done before and at the end of device use. Pelvic muscle strength was measured at baseline and at the end of the trial. Patients scored their symptoms on visual analog scales and completed quality-of-life questionnaires before and after therapy. RESULTS: Significant improvements from baseline were found in patients using active devices but not in controls. Comparisons of changes from baseline between active-device and control patients showed that active-device patients had significantly greater improvement in weekly (p = 0.009) and daily (p = 0.04) leakage episodes, pad testing (p = 0.005), and vaginal muscle strength (p = 0.02) when compared with control subjects. Significantly greater improvement was also found for both visual analog scores of urinary incontinence (p = 0.007) and stress incontinence (p = 0.02), as well as for subjective reporting of frequency of urine loss (p = 0.002), and urine loss with sneezing, coughing, or laughing (p = 0.02), when compared with controls. Pad testing showed that stress incontinence was improved by at least 50% in 62% of patients using an active device compared with only 19% of patients using sham devices (p = 0.01). Voiding diaries showed at least 50% improvement in 48% of active-device patients compared with 13% of women using the sham device (p = 0.02). No irreversible adverse effects were noted in either group. CONCLUSIONS: Transvaginal pelvic floor electrical stimulation was found to be a safe and effective therapy for genuine stress incontinence.

Pelvic floor rehabilitation in the treatment of incontinence.

This study assessed the effectiveness of a pelvic floor rehabilitation program in a clinical practice. A retrospective convenience sample of 48 women was evaluated pretreatment and posttreatment with follow-up interviews from six months to three years. This group consisted of 81% with stress urinary incontinence, 6% with unstable bladder and 10% with mixed incontinence. Fecal incontinence was present as well in 35% of the subjects. The patients were taught pelvic floor muscle exercises and instruction reinforced with electromyographic biofeedback. Neuromuscular electrical stimulation was used when clinically indicated. Two women did not continue the program beyond the first visit and were excluded. Sixty-two percent of patients with two or more visits demonstrated an improvement. Thirteen percent were completely dry, and 49% demonstrated a significant improvement. Patients with genuine stress urinary incontinence, unstable bladder and mixed incontinence showed a 66%, 33% and 50% improvement rate, respectively. Fecal incontinence was improved in 63% of women trained in pelvic floor muscle exercises. A significant decrease (P < .001) was found in the frequency of self-reported leakage at the six-month to three-year follow-up. The strength and duration of a pelvic muscle contraction was significantly greater between the first and last visit in all patients, regardless of the subjective improvement. A pelvic floor rehabilitation program was an effective alternative to surgical intervention in reducing the frequency of urinary leakage. Further studies are needed to identify factors predicting success and to determine the most cost-effective method of achieving pelvic floor rehabilitation.