Vol. 9, No. 3 Printed in Great Britain
Family Practice O Oxford University Press 1992
The Effects of Treatment of Urinary Incontinence in General Practice ALM LAGRO-JANSSEN, FMJ DEBRUYNE. AJA SMITS AND C VAN WEEL
1987 and 1 January 1990. Incontinence was defined as the involuntary loss of urine twice or more per month. Thirteen general practices cooperated in the project. Patients who had previously undergone surgery for incontinence, suffered from neurological diseases which may cause incontinence, or who had a urinary tract infection were excluded. Microscopy was performed routinely to eliminate the possibility of urinary tract infections, and a urine culture was performed if there was doubt. Those with such an infection were included in the study later if incontinence persisted after therapy. The general practitioners recorded the following information for all the women, whether they agreed to participate or not: sociodemographic data, other diseases, medication and severity and type of incontinence (from case notes). An extensive standard history was taken of each selected patient by one and the same general practitioner. A gynaecological examination was then performed, followed by a complete urodynamic evaluation performed by a specialist nurse. The type of incontinence was diagnosed according to the criteria of the International Continence Society.8 An objective assessment of the severity of the incontinence was made using four indices (Appendix 1). Incontinence was divided into three categories—mild, moderate, severe—on the basis of the total score attained. The patients also recorded the frequency of wet episodes on a 7-day bladder chart.4 The patients were then
INTRODUCTION Research projects into the results of treatment of stress incontinence using pelvic floor exercises have mainly involved out-patients, usually without control groups, or using controls who received treatment, either surgery1 or specific types of physiotherapy.2^1 The therapy evaluation points mostly vary from 4 weeks to 6 months. Studies of the treatment of urge incontinence by means of bladder training yield the same conclusion: few such studies have included control groups and little is known about long-term effects.5'6 Only one study has reported results from general practice.7 Because of the high prevalence of urinary incontinence and its impact on the quality of life it is very important to have available a simple and cheap treatment in general practice. The present study therefore addressed the questions of the effect of the treatment of urinary incontinence in general practice by means of pelvic floor exercises and bladder training respectively, and whether this effect continues after one year. METHOD The study population comprised all women between 20 and 65 years of age who reported incontinence to their general practitioners in the period between 1 January Correspondence to: ALM Lagro-Janssen, Nijmegen University, Department of General Practice, Verlengde Groenestraat 75, PO Box 6101, 6500 HB Nijmegen, The Netherlands.
284
Downloaded from http://fampra.oxfordjournals.org/ at Florida Atlantic University on September 13, 2015
Lagro-Janssen ALM, Debruyne FMJ, Smits AJA and van Weel C. The effects of treatment of urinary incontinence in general practice. Family Practice 1992; 9: 284-289. A total of 110 women who had reported urinary incontinence to their general practitioners were randomly assigned to a treatment or control group. Treatment consisted of pelvic floor exercises in the case of stress incontinence and bladder training in the case of urge incontinence. The results were measured after 3 and 12 months by a research assistant on the basis of a constructed severity scale, an incontinence diary, and a comparison by the patients themselves of their previous and current conditions. After 3 months the control group were given the same treatment. After a further 3 and 12 months, they were assessed in exactly the same way as the treatment group. After 3 months about 60% of the patients were either dry or only mildly incontinent; the mean number of wet episodes had gone down from 20 to 7, and 74% of the women felt improved or cured. These results were later corroborated by the control group. After 12 months this successful outcome was improved slightly further. It may be concluded that the majority of women with incontinence can be successfully treated by the general practitioner. The effect of this treatment continues after one year.
TREATMENT OF URINARY INCONTINENCE
overall score was calculated by adding the percentages and dividing the total by three. The objective measures of severity and frequency of incontinence using the 7-day bladder chart were repeated. The patients who received treatment were asked how well they had kept to the treatment programme—excellently, well, reasonably, poorly, not at all—and whether they had received other therapies than those required in the trial. Student's /-test was used to compare the treatment and control groups, while the results before and after treatment were compared by means of a paired student's /-test. The study was approved by the medical ethics committee of the University of Nijmegen. The patients were informed about the study design and agreed on the terms of the study. RESULTS The general practitioners selected 146 women, 36 of whom refused to participate (response rate 75%). The main reason for not taking part in the trial (23 women) was that they did not consider their incontinence serious enough for further investigation. The relevant characteristics of participants and non-participants largely coincided, except that mild incontinence was more frequent among the non-participants (56%) than among the participants (7%). The 110 women selected were randomly assigned to the treatment and control groups, which were largely equal to each other (Table 1). The 33 women with genuine stress incontinence revealed by urodynamic testing, were given pelvic floor exercises; the nine women with urge incontinence received bladder training, while the 11 patients with mixed incontinence were given pelvic floor exercises initially, followed by bladder training. The composition of the control group was identical to that of the treatment group, and after 3 months without treatment, the same numbers of women were given their corresponding treatment. After 3 months one patient in the treatment group had withdrawn from treatment (because of pregnancy); all the women in the control group completed the first 3 months of the trial. After another 3 months three women had dropped out from the control group (one because of a stroke, one because of serious personal problems and one because she did not want to wait any longer for surgery). All four women suffered from moderate to severe stress incontinence. All the women in both the treatment and control groups completed the lasting months of the trial. Only one patient with stress incontinence in the treatment group received additional physiotherapy. After 3 months 62% of the patients had complied 'excellently' or 'well' with the exercises, 20% 'reasonably' and 18% 'poorly' or 'not at all'. After 12 months these proportions were 51%, 18% and 31%. There were no differences between treatment and control groups in this respect.
Downloaded from http://fampra.oxfordjournals.org/ at Florida Atlantic University on September 13, 2015
assigned consecutively to the treatment or control groups which were stratified on the basis of type and severity of their incontinence. At the start of the trial both groups received advice and instructions from a practice assistant about protective aids such as incontinence pads, but the control group did not receive further treatment in the first 3 months of the trial. After the 3 months' evaluation the patients in the control group were instructed in the same way as those in the treatment group, according to the type of incontinence. After a further 3 months the outcome was evaluated using the same protocol. The control's condition after treatment was compared with that before treatment; a comparison in which each patient acted as her own control. Finally 1 year after starting treatment all patients—treatment and control groups—were evaluated using the same protocol as before. The treatment for stress incontinence and urge incontinence consisted of pelvic floor exercises and bladder training respectively, while a mixed incontinence was treated by means of bladder training followed by pelvic floor exercises. The instructions for pelvic floor exercises were given by the general practitioner researcher and first of all included information about the function of the pelvic floor muscles and about how to contract the correct muscles. To that end the patient was asked during a gynaecological examination to imagine she was attempting to hold back the flow of urine. If the right muscles were contracted correctly, the patient was asked to continue the contraction for 6 s and then relax the pelvic floor muscles again. Special attention was paid to avoid the improper contraction of the abdominal, gluteal or adductor muscles. Then the patients received written instructions for the exercises and a schedule for 5-10 daily sessions of 10 exercises each to be done during their usual daily activities. The bladder training involved the following elements. First, the general practitioner researcher provided information about the loss of the bladder's reseTvoir function and about the possibility of restoring this function through exercises. The main message was that voiding should take place at fixed voidings rather than on desire. The patients were therefore given a diary to record voidings and any episode of incontinence. The time interval between voidings then had to be increased by 15 min. The ultimate aim was to reach a maximum voiding frequency of seven at an ordinary fluid intake. The results of the therapy were evaluated by a research assistant after 3 and 12 months in case of patients in the treatment group and after 3, 6 and 15 months in case of patients in the control group. In a subjective assessment patients were asked whether, compared to the previous measuring point, the problem had been cured, improved, remained unchanged or deteriorated with respect to the level of incontinence, the psychological impact of incontinence and restrictions in activities caused by the incontinence. An
285
286
FAMILY PRACTICE—AN INTERNATIONAL JOURNAL TABLE 1 Characteristics of treatment and control groups (n = 110) Control group (n - 56)
Treatment group (» = 54) Mean age (years) (SD) Mean parity (SD)
44.6
(10.4)
42.3
(10.0)
0.2*
2.3
(1.3)
2.2
(1.6)
0.9*
12
(22%)
16
(29%)
0.4 +
Presence with other diseases
29
(54%)
25
(45%)
0.3 +
Presence cystocele
16
(30%)
21
(37%)
0.4 +
Type of incontinence Genuine stress Mixed incontinence Urge incontinence Others
33 11 9 1
(61%) (20%) (17%) (2%)
33 9 9 5
(59%) (16%) (16%) (9%)
0.4 +
Severity of incontinence Mild Moderate Severe
5 29 20
(9%) (54%) (37%)
2 32 22
(4%) (57%) (39%)
0.5 +
Mean numbeT of wet episodes (SD)
19.6
(15.6)
21.0
(13.8)
0.6*
Duration of incontinence < 2 years 2-5 years > 5 years
19 9 26
(35%) (17%) (48%)
20 20 16
(36%) (36%) (28%)
Family Practice O Oxford University Press 1992
The Effects of Treatment of Urinary Incontinence in General Practice ALM LAGRO-JANSSEN, FMJ DEBRUYNE. AJA SMITS AND C VAN WEEL
1987 and 1 January 1990. Incontinence was defined as the involuntary loss of urine twice or more per month. Thirteen general practices cooperated in the project. Patients who had previously undergone surgery for incontinence, suffered from neurological diseases which may cause incontinence, or who had a urinary tract infection were excluded. Microscopy was performed routinely to eliminate the possibility of urinary tract infections, and a urine culture was performed if there was doubt. Those with such an infection were included in the study later if incontinence persisted after therapy. The general practitioners recorded the following information for all the women, whether they agreed to participate or not: sociodemographic data, other diseases, medication and severity and type of incontinence (from case notes). An extensive standard history was taken of each selected patient by one and the same general practitioner. A gynaecological examination was then performed, followed by a complete urodynamic evaluation performed by a specialist nurse. The type of incontinence was diagnosed according to the criteria of the International Continence Society.8 An objective assessment of the severity of the incontinence was made using four indices (Appendix 1). Incontinence was divided into three categories—mild, moderate, severe—on the basis of the total score attained. The patients also recorded the frequency of wet episodes on a 7-day bladder chart.4 The patients were then
INTRODUCTION Research projects into the results of treatment of stress incontinence using pelvic floor exercises have mainly involved out-patients, usually without control groups, or using controls who received treatment, either surgery1 or specific types of physiotherapy.2^1 The therapy evaluation points mostly vary from 4 weeks to 6 months. Studies of the treatment of urge incontinence by means of bladder training yield the same conclusion: few such studies have included control groups and little is known about long-term effects.5'6 Only one study has reported results from general practice.7 Because of the high prevalence of urinary incontinence and its impact on the quality of life it is very important to have available a simple and cheap treatment in general practice. The present study therefore addressed the questions of the effect of the treatment of urinary incontinence in general practice by means of pelvic floor exercises and bladder training respectively, and whether this effect continues after one year. METHOD The study population comprised all women between 20 and 65 years of age who reported incontinence to their general practitioners in the period between 1 January Correspondence to: ALM Lagro-Janssen, Nijmegen University, Department of General Practice, Verlengde Groenestraat 75, PO Box 6101, 6500 HB Nijmegen, The Netherlands.
284
Downloaded from http://fampra.oxfordjournals.org/ at Florida Atlantic University on September 13, 2015
Lagro-Janssen ALM, Debruyne FMJ, Smits AJA and van Weel C. The effects of treatment of urinary incontinence in general practice. Family Practice 1992; 9: 284-289. A total of 110 women who had reported urinary incontinence to their general practitioners were randomly assigned to a treatment or control group. Treatment consisted of pelvic floor exercises in the case of stress incontinence and bladder training in the case of urge incontinence. The results were measured after 3 and 12 months by a research assistant on the basis of a constructed severity scale, an incontinence diary, and a comparison by the patients themselves of their previous and current conditions. After 3 months the control group were given the same treatment. After a further 3 and 12 months, they were assessed in exactly the same way as the treatment group. After 3 months about 60% of the patients were either dry or only mildly incontinent; the mean number of wet episodes had gone down from 20 to 7, and 74% of the women felt improved or cured. These results were later corroborated by the control group. After 12 months this successful outcome was improved slightly further. It may be concluded that the majority of women with incontinence can be successfully treated by the general practitioner. The effect of this treatment continues after one year.
TREATMENT OF URINARY INCONTINENCE
overall score was calculated by adding the percentages and dividing the total by three. The objective measures of severity and frequency of incontinence using the 7-day bladder chart were repeated. The patients who received treatment were asked how well they had kept to the treatment programme—excellently, well, reasonably, poorly, not at all—and whether they had received other therapies than those required in the trial. Student's /-test was used to compare the treatment and control groups, while the results before and after treatment were compared by means of a paired student's /-test. The study was approved by the medical ethics committee of the University of Nijmegen. The patients were informed about the study design and agreed on the terms of the study. RESULTS The general practitioners selected 146 women, 36 of whom refused to participate (response rate 75%). The main reason for not taking part in the trial (23 women) was that they did not consider their incontinence serious enough for further investigation. The relevant characteristics of participants and non-participants largely coincided, except that mild incontinence was more frequent among the non-participants (56%) than among the participants (7%). The 110 women selected were randomly assigned to the treatment and control groups, which were largely equal to each other (Table 1). The 33 women with genuine stress incontinence revealed by urodynamic testing, were given pelvic floor exercises; the nine women with urge incontinence received bladder training, while the 11 patients with mixed incontinence were given pelvic floor exercises initially, followed by bladder training. The composition of the control group was identical to that of the treatment group, and after 3 months without treatment, the same numbers of women were given their corresponding treatment. After 3 months one patient in the treatment group had withdrawn from treatment (because of pregnancy); all the women in the control group completed the first 3 months of the trial. After another 3 months three women had dropped out from the control group (one because of a stroke, one because of serious personal problems and one because she did not want to wait any longer for surgery). All four women suffered from moderate to severe stress incontinence. All the women in both the treatment and control groups completed the lasting months of the trial. Only one patient with stress incontinence in the treatment group received additional physiotherapy. After 3 months 62% of the patients had complied 'excellently' or 'well' with the exercises, 20% 'reasonably' and 18% 'poorly' or 'not at all'. After 12 months these proportions were 51%, 18% and 31%. There were no differences between treatment and control groups in this respect.
Downloaded from http://fampra.oxfordjournals.org/ at Florida Atlantic University on September 13, 2015
assigned consecutively to the treatment or control groups which were stratified on the basis of type and severity of their incontinence. At the start of the trial both groups received advice and instructions from a practice assistant about protective aids such as incontinence pads, but the control group did not receive further treatment in the first 3 months of the trial. After the 3 months' evaluation the patients in the control group were instructed in the same way as those in the treatment group, according to the type of incontinence. After a further 3 months the outcome was evaluated using the same protocol. The control's condition after treatment was compared with that before treatment; a comparison in which each patient acted as her own control. Finally 1 year after starting treatment all patients—treatment and control groups—were evaluated using the same protocol as before. The treatment for stress incontinence and urge incontinence consisted of pelvic floor exercises and bladder training respectively, while a mixed incontinence was treated by means of bladder training followed by pelvic floor exercises. The instructions for pelvic floor exercises were given by the general practitioner researcher and first of all included information about the function of the pelvic floor muscles and about how to contract the correct muscles. To that end the patient was asked during a gynaecological examination to imagine she was attempting to hold back the flow of urine. If the right muscles were contracted correctly, the patient was asked to continue the contraction for 6 s and then relax the pelvic floor muscles again. Special attention was paid to avoid the improper contraction of the abdominal, gluteal or adductor muscles. Then the patients received written instructions for the exercises and a schedule for 5-10 daily sessions of 10 exercises each to be done during their usual daily activities. The bladder training involved the following elements. First, the general practitioner researcher provided information about the loss of the bladder's reseTvoir function and about the possibility of restoring this function through exercises. The main message was that voiding should take place at fixed voidings rather than on desire. The patients were therefore given a diary to record voidings and any episode of incontinence. The time interval between voidings then had to be increased by 15 min. The ultimate aim was to reach a maximum voiding frequency of seven at an ordinary fluid intake. The results of the therapy were evaluated by a research assistant after 3 and 12 months in case of patients in the treatment group and after 3, 6 and 15 months in case of patients in the control group. In a subjective assessment patients were asked whether, compared to the previous measuring point, the problem had been cured, improved, remained unchanged or deteriorated with respect to the level of incontinence, the psychological impact of incontinence and restrictions in activities caused by the incontinence. An
285
286
FAMILY PRACTICE—AN INTERNATIONAL JOURNAL TABLE 1 Characteristics of treatment and control groups (n = 110) Control group (n - 56)
Treatment group (» = 54) Mean age (years) (SD) Mean parity (SD)
44.6
(10.4)
42.3
(10.0)
0.2*
2.3
(1.3)
2.2
(1.6)
0.9*
12
(22%)
16
(29%)
0.4 +
Presence with other diseases
29
(54%)
25
(45%)
0.3 +
Presence cystocele
16
(30%)
21
(37%)
0.4 +
Type of incontinence Genuine stress Mixed incontinence Urge incontinence Others
33 11 9 1
(61%) (20%) (17%) (2%)
33 9 9 5
(59%) (16%) (16%) (9%)
0.4 +
Severity of incontinence Mild Moderate Severe
5 29 20
(9%) (54%) (37%)
2 32 22
(4%) (57%) (39%)
0.5 +
Mean numbeT of wet episodes (SD)
19.6
(15.6)
21.0
(13.8)
0.6*
Duration of incontinence < 2 years 2-5 years > 5 years
19 9 26
(35%) (17%) (48%)
20 20 16
(36%) (36%) (28%)
