Oxybutynin for detrusor instability with adjuvant salivary stimulant pastilles to improve compliance: results of a multicentre, randomized controlled trial.

OBJECTIVE: To test the hypothesis that compliance with oxybutynin would be improved if the severity of dry mouth could be reduced, thus leading to improved urinary symptom response and improved outcome, in a randomized, controlled trial of oxybutynin with or without salivary stimulant pastilles in patients with detrusor instability. PATIENTS AND METHODS: Sixty-seven women with detrusor instability were randomized to a variable dose regimen of oxybutynin with (37) or without (30) salivary stimulant pastilles for 8 weeks. Patients were asked to complete a baseline voiding diary. In weeks 1 and 2, patients were encouraged to adjust the dose of oxybutynin themselves to achieve optimum symptomatic control. A second diary was completed in the sixth week and patients were reviewed at 8 weeks. The outcome measures were the compliance rate, follow-up attendance rate, maximum dose of medication, changes in voiding and incontinence episodes, and changes in severity of urgency and of dry mouth symptoms between the first and sixth week. RESULTS: Of the 67 women, 32 (47%) completed the study; the proportion completing was the same in both groups. Four patients had stopped the medication and there was no difference in the distribution of maximum dosage achieved between the groups. Both groups reported a reduced severity of urgency symptoms and increased severity of dry mouth. There were no differences in reported symptom change between the groups during the study. CONCLUSIONS: The combination of oxybutynin and salivary stimulant pastilles does not improve compliance or symptom relief compared with oxybutynin alone; it does not allow a greater dose of oxybutynin to be tolerated.

Increase in presumptive sensory nerves of the urinary bladder in idiopathic detrusor instability.

The density of subepithelial, presumptive sensory nerves in the bladder wall was assessed in 21 women with idiopathic detrusor instability and compared with the density of these nerves in 21 asymptomatic women, using a point-counting technique on sections of bladder biopsies stained for acetylcholinesterase activity. The mean value (+/- S.E.) for the amount of such nerves in patients with detrusor instability (91 +/- 13/mm2) was significantly greater than that from the control group (61 +/- 7/mm2). This suggests that a relative abundance of subepithelial sensory nerves may serve to increase the appreciation of bladder filling, giving rise to the frequency and urgency of micturition which are characteristic of patients with detrusor instability.

Detrusor mast cells in refractory idiopathic instability.

The diagnosis of interstitial cystitis (IC) is not usually considered in patients with idiopathic instability. Because histamine provokes detrusor contractions in vitro, we assessed detrusor mast cell counts in 29 females with refractory instability. Raised mast cell counts (greater than 28/mm2 of detrusor muscle, consistent with a histological diagnosis of IC) were found in 29% of such cases. Thus cystoscopy and bladder biopsy should be considered in patients with idiopathic instability which fails to respond to anticholinergic drugs, as alternative therapy may be useful. Patients with refractory instability and normal detrusor mast cell counts often gave a history of prolonged childhood nocturnal enuresis (55% of cases); in contrast, patients with intractable instability and abnormally high mast cell counts seldom gave such a history (12%). These trends may give some insight into the aetiology of idiopathic instability--"congenital" or acquired?

Crouching over the toilet seat: prevalence among British gynaecological outpatients and its effect upon micturition.

This study investigated whether British women prefer to crouch over public toilet seats, and measured the effect of such a voiding position on urine flow rate and residual urine volume. Of 528 consecutive women who attended a general gynaecological clinic and completed an anonymous questionnaire, 85% usually crouched over the toilet when using a public convenience, 12% applied paper to the seat and 2% sat directly on public toilet seats. When using a friend's bathroom 38% of the women voided by crouching. Results were similar for 155 patients attending a urodynamic clinic, 80 of whom were studied while voiding in both positions. There was a 21% reduction in average urine flow rate and a 149% increase in residual urine volume in the crouching position. Women undergoing urodynamic tests should be asked which voiding position they used before abnormal results are interpreted. Patients with a reduced functional bladder capacity may benefit from being encouraged to sit comfortably on the toilet whenever possible.

Response to treatment of detrusor instability in relation to psychoneurotic status.

A total of 53 females who entered a double-blind crossover trial of oxybutynin and placebo for idiopathic detrusor instability were questioned about life events and associated medical disorders and were given a psychometric test. Their response to treatment was studied in relation to these factors. It was found that 11% of patients had nocturnal enuresis beyond age 8 and 25% had irritable bowel syndrome: their response to treatment was generally poor. Life events were not consistently related to treatment response. The mean psychoneurotic score of "poor responders" (43.7) was similar to that of female psychoneurotic out-patients (47.7), although one-third of poor responders were normal. Patients who responded well to simple anticholinergic treatment had a mean score (30.7), which was similar to that of normal urban females (33.5). Most good responders and one-third of poor responders showed little evidence of psychoneuroticism: a further search for neurophysiological abnormality in idiopathic detrusor instability is needed.

Burch colposuspension or sling for stress incontinence? A prospective study using transrectal ultrasound.

Twenty-nine women with stress incontinence were treated surgically by Burch colposuspension or ox fascial sling. The operation was selected prospectively according to the transrectal ultrasound appearance of the bladder neck and urethra during stress. Two groups were defined according to the extent of bladder neck descent and posterior rotation during stress: Type I (minimal descent, i.e. less than 1.5 cm) and Type II (downward posterior rotational movement). Success rates of 76% are reported and the action of each procedure is discussed.

Is the investigation of most stress incontinence really necessary?

The case histories of 494 women referred to a urodynamic clinic with the symptom of stress incontinence were studied. None had undergone previous incontinence surgery. In only 12 patients was stress incontinence the sole symptom. In the remainder, symptoms suggestive of detrusor instability were present in 417, of a voiding disorder in 261 and of an inflammatory disorder in 166. The sign of stress incontinence was present in only 168 patients and was not a reliable guide to the diagnosis of genuine stress incontinence. Urodynamic studies were necessary in 488 patients in order to obtain an accurate diagnosis.

Evaluation of the home pad test for quantifying incontinence.

The home pad test to quantify urinary incontinence is described. Patients conduct the test in their homes and bring the pad, in a self-sealing plastic bag, for weighing at their next clinic visit. The validity of the procedure was assessed by measuring evaporation loss from the pads and comparing the home with the standard hospital test. Evaporation loss was shown to be acceptable if the test was carried out within 72 h of weighing. There were no significant differences between home and hospital tests and 95% of home results were within 32% below to 16% above hospital results. This was at least as consistent as the "gold standard" hospital test as 95% of the hospital results were within 28% below to 44% above repeated test results. The principal advantages in performing the pad test at home are simplicity, cost effectiveness and the relaxed environment, which reproduces more accurately the conditions leading to incontinence when compared with the relatively unfamiliar hospital setting.

Maximum and average urine flow rates in normal male and female populations--the Liverpool nomograms.

The study of voiding in men and women has been handicapped by the lack of a normal reference range covering urinary flow rates over a wide range of voided volumes. Normal volunteers (331 males and 249 females) were studied. Each voided once into a calibrated Dantec Urodyn 1000 mictiograph. On a second occasion 282 men and 46 women voided. The maximum and average urine flow rates of the first voids in both sexes were compared with the respective voided volumes. Nomogram charts, in centile form, for both the maximum and average urine flow rates were constructed using statistical transformations of the data. Males showed a significant decline in both urinary flow rates with age, although there was no statistically significant variation in either urine flow rate with respect to first versus repeated voiding. Females showed no statistically significant variation in either urine flow rate with respect to age, parity or first versus repeated voiding. The maximum and average urine flow rates in both sexes showed an equally strong relationship to voided volume. No artificial restriction of voided volume, e.g. minimum 200 ml, appeared appropriate. These nomograms offer reference ranges for both maximum and average urinary flow rates in both sexes covering a wide range of voided volumes (15-600 ml).

Clinical application of transrectal ultrasound for the investigation of the incontinent patient.

A transrectal ultrasound technique is described for imaging the bladder neck and urethra. A group of 25 continent female volunteers was examined initially; 59 incontinent women were then studied pre-operatively and again 6 months after either a Burch colposuspension, Pereyra operation or ox fascial sling to determine the ultrasonic characteristics of successful surgery.

The accuracy of measurement of residual urine in women by urethral catheterisation.

Two potential sources of error in the measurement of residual urine volumes in women were quantified. These were (i) whether a diuresis is operating at the time of measurement, and (ii) the time between voiding and residual urine volume collection. A regime is suggested for the accurate measurement of residual urine in women by urethral catheterisation.

Transvaginal ultrasound in the assessment of bladder volumes in women. Preliminary report.

Transvaginal linear array ultrasound is described as a method of measuring bladder volumes in the range 2 to 175 ml, overcoming the limitations of abdominal ultrasound at these smaller (though clinically important) volumes. The mean error over the range 10 to 175 ml was 23%. Statistical analysis of preliminary data obtained by this technique shows that bladder volume in ml can be calculated by the formula: Volume = 5.9 x (height x depth) - 14.6 ml (95% confidence limits = +/- 37 ml)

The severity of urinary incontinence in women. Comparison of subjective and objective tests.

The subjective assessment of urine loss in 84 incontinent women was quantified by using a 10-cm visual analogue scale. These results were compared with the results of a 2-h pad weighing test. We found no relationship between a patient's subjective impression of the severity of her incontinence and the corresponding objective assessment by a 2-h pad weighing test.

Diuretic response to fluid load in women with urinary incontinence: optimum duration of pad test.

The pattern of bladder filling in response to a 1-litre fluid load was assessed in 20 women with urinary incontinence. The period between 60 and 120 min after the fluid load was identified as best for pad testing because of consistently high bladder volumes and filling rates. A 2-h pad test is recommended as achieving effective and reproducible test conditions for the quantification of urine loss.

Vaginal pressure as an index of intra-abdominal pressure during urodynamic evaluation.

Vaginal pressure was measured using balloon catheters in 20 patients and open-ended fluid-filled catheters in another 21. The results showed excellent correlation between vaginal, vesical and rectal pressures in response to changes in abdominal pressure.

Quantification of urine loss by weighing perineal pads. Observation on the exercise regimen.

Two variations on a test for quantifying urine loss in patients with urinary incontinence were compared. In the first series (Padtest 1), 335 patients underwent a 2-h pad weighing test. A fluid load of 1 litre was administered and followed 1 h later by six separate exercises, each lasting 10 min. One of six sanitary towels was worn during each exercise. Each pad was weighed before and after use to provide information about the severity of the incontinence. In the second series (Padtest 2), 104 patients were studied. The test took the same format but the exercises were rearranged in an attempt to provide information about the importance of the individual exercises. Hand washing was found to be a very provocative test both in women with unstable and those with stable bladders. The order in which the exercises were performed did not influence the overall identification of incontinence in the 2-h test period, and this supports the conclusion that the optimum length of the test is 2 h.

Analysis of the pattern of urine loss in women with incontinence as measured by weighing perineal pads.

Three hundred and thirty-five women with urinary incontinence underwent a pad-weighing test for quantifying urine loss. Each one wore a series of pre-weighed sanitary towels for a total of 1 h. The pads were weighed again after use. The test results gave information about the severity of the incontinence which was not easy to obtain either from patient interview or from clinical examination. The type of activity was the main factor determining urine loss, although patients with detrusor instability lost more on average than the others. Voiding during the test period did not appear to influence the overall test results. Reproducibility of the test has been studied in 50 patients.