| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
ORIGINAL RESEARCH |
From the Incontinence Clinic, Department of Urology, Hvidovre Hospital, University of Copenhagen, and the Department of Gynecology and Obstetrics, Glostrup County Hospital, University of Copenhagen, Glostrup, Denmark.
Address reprint requests to: Pia Sander, MD, The Incontinence Clinic, Department of Urology, Hvidovre Hospital, University of Copenhagen, Kohavevej 19, Vedbaek 2950, Denmark
 |
Abstract |
|---|
Top
 Abstract Materials and MethodsResultsDiscussionReferences |
|---|
Methods: Fifty-five women with stress incontinence participated in a 3-month study. They were assessed by the Incontinence Impact Questionnaire, two incontinence-related quality-of-life questions, a generic quality-of-life questionnaire (Short Form-36), two 24-hour home pad weighing tests, a 2-day voiding diary, uroflowmetry, urine cultures, and a questionnaire about subjective effectiveness of the device.
Results: Forty-one (74.5%) women completed the study. Estimated on an intent-to-treat basis, the vaginal device was associated with subjective cure in 11 women (20%) and improvement in 27 (49%). The mean 24-hour pad test leakage and leakage episodes in the voiding diary decreased significantly. Fifty-eight percent of the 55 women enrolled wanted to continue using the device after 3 months. The quality of life measured by the Incontinence Impact Questionnaire showed highly significant improvement, and the results of the two incontinence-related quality of life questions also showed significant improvement. Responses to the Short Form-36 general health questionnaire showed no significant changes. Improvement on the Incontinence Impact Questionnaire correlated with improvements in incontinence, whereas the Short Form-36 scores were unchanged.
Conclusion: Treatment with the Continence Guard significantly decreases leakage and improves quality of life in women with symptoms of urinary stress incontinence. An incontinence-specific, rather than a generic, quality-of-life questionnaire was important in assessing treatment outcomes.
Urinary stress incontinence, a common problem in middle-aged and older women,1 might affect quality of life, and studies have shown the greatest effect on physical, social, and emotional domains.2–4 The largest effect is in women with urge incontinence or severe urinary leakage.2,3,5,6 Traditional clinical efficacy outcome measures showed poor correlation with patients’ perceptions of treatments, results, and quality of life.7 The importance of measuring quality of life in clinical trials has been increasingly acknowledged.
Because many women prefer nonsurgical treatment, several vaginal devices have been developed to alleviate stress urinary incontinence.8–13 The Continence Guard (Coloplast A/S, Kokkedal, Denmark) has proved effective, well accepted, and safe in managing stress incontinence; however, its effect on quality of life is unknown.8,13,14 The aim of the present study was to assess the effect on quality of life of the Continence Guard in women with urinary stress incontinence.
|
Materials and Methods |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
All subjects had complete histories and physical examinations, including pelvic examinations, two 24-hour home pad weighing tests, 2-day voiding diaries, uroflowmetry studies, urine cultures, and ultrasonic postvoid residual urine measurements. The number of pads used per 24 hours was recorded. The existence of the symptom of stress incontinence was based on the patient’s history, a 24-hour pad weighing test showing leakage exceeding 7 g per 24 hours,15 a 2-day voiding diary, and exclusion of impaired bladder emptying. International Continence Society terminology and definitions were applied.16
Patients completed the Incontinence Impact Questionnaire, which measures the effect of urinary incontinence on various activities, roles, and emotional states.17 It consists of 30 items, divided into four sub-scales, physical activity (six items), travel (six items), social relationships (ten items), and emotional health (eight items). The subscales range from 0–100, and the sum of all subscales ranges from 0–400. A high score indicates severe effect. The Incontinence Impact Questionnaire has been demonstrated to be very strong psychometrically.17 The questionnaire was translated carefully, based on iterative forward-backward procedures, and pilot-tested in 15 women.18 Patients answered two additional incontinence-related quality-of-life questions: 1. If you had to spend the rest of your life with your urinary symptoms as they are now, how would you feel about it?1–4 (content rating of untreated condition) and 2. All in all, how much of a problem are your urinary symptoms for you?1–4 (overall troublesomeness).19 The subjects then completed the Danish Short Form-36 questionnaire, which measures general subjective health status.20,21 The questionnaire is short, with 36 items covering eight health scales using the recommended guidelines of physical function, role limitations caused by physical problems, body pain, general health, vitality, social function, role limitations caused by emotional problems, and mental health.22 Each scale is from 0 (worst possible health status measured by the questionnaire) to 100 (best possible health status).
After 3 months’ use, all the examinations were repeated with the vaginal device in place, and the questionnaires were answered again. A questionnaire about the subjective effectiveness of the device was completed also, and side effects were recorded.
The women received written, verbal, and practical instruction using the vaginal device and were given test packs of the three available sizes. They were instructed to use the size that gave the most improvement without discomfort. We recommended using the device from morning till night. During menstruation the device was changed every 4–6 hours. The vaginal device (Figure 1
) is made of a documented tissue-compatible, soft, smooth polyurethane foam.23 The device is arc shaped and inserted in the vagina by means of an applicator (Figure 2). Long-term testing has found it well accepted and safe.14 In Europe it is available to patients over the counter. In the United States the company is applying for approval from the Food and Drug Administration.
|
|
2 test, Kruskal-Wallis test, Mann-Whitney test, Wilcoxon signed-rank test, Pearson correlation test, and Spearman 
correlation test. The level of significance was .05. |
Results |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
), and residual urine.
The quality-of-life score measured by the Incontinence Impact Questionnaire improved significantly after 3 months’ use of the device in all four subscales and in the total score (Table 1). Improvement was high in all the subscales, but highest in the physical activity scale. The two incontinence-related quality-of-life questions (content rating of untreated condition and overall troublesomeness) also showed significant improvement (Table 2). The Short Form-36 general health questionnaire revealed no significant changes from baseline after the 3-month study period (Table 1). Sixty percent of the women became more physically active during treatment.
|
|
correlation coefficient = 0.43, P = .005). No differences were found in subjective results, reduction of leakage measured by the pad weighing test, and decrease in the Incontinence Impact Questionnaire scores according to age, type of incontinence, hormone status, previous hysterectomy, findings at pelvic examination (descensus or atrophy), leakage at pad weighing test, number of incontinence episodes in the voiding diary, discomfort during test period, size of device used, and Incontinence Impact Questionnaire scores.
Decreases in total Incontinence Impact Questionnaire scores showed significant correlation to subjective results (Pearson correlation coefficient = 0.4, P = .013) and to decreases in leakage in pad weighing test (Pearson correlation coefficient = 0.4, P = .015). Incontinence Impact Questionnaire scores showed no significant correlation with decreases in incontinence episodes.
During the study, the device caused some mild local discomfort in 14 women, only four of whom did not wish to continue using the device after 3 months. Another five did not wish to continue using the device, two because of lack of effect and three because they were offered a pelvic floor training program. In all, 32 of the intent-to-treat women (58%) wished to continue using the device. The women who wanted to continue using the device were not significantly different from the women who withdrew or did not want to continue using the device in age, type of incontinence, hormone status, earlier hysterectomy, vaginal repair, leakage at pad weighing test, findings at pelvic examination (descensus or atrophy), the Incontinence Impact Questionnaire scores, and Short Form-36 scores. In the two incontinence-related quality-of-life questions asked before treatment, women who wished to continue using the device were more unsatisfied in content rating of untreated condition (P = .04) and they found their urinary symptoms more troublesome (P = .003).
Women who wanted to continue using the device had significantly better subjective results (P = .02), higher reduction of leakage at pad weighing test (P = .048), higher decrease in total Incontinence Impact Questionnaire scores (P = .02), and higher improvement in the two incontinence-related quality-of-life questions (P < .001).
|
Discussion |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
In the important new efficacy index, we showed highly significant improvement in quality of life in all four subscales and total score, measured by the psychometrically strong Incontinence Impact Questionnaire,17 which was carefully translated into Danish and tested. The device also significantly improved quality of life according to two incontinence-related quality-of-life questions. From the Short Form-36 general health questionnaire, we found no significant changes from baseline after treatment. Although improvements in the Incontinence Impact Questionnaire correlated significantly with improvements in incontinence, no similar association was seen with the Short Form-36 score, which did not change. However, the Short Form-36 general health questionnaire, used in other studies, has shown the same poor sensitivity to clinical improvements in urinary symptoms and patient well-being. After intervention for incontinence, four studies (two of them only in abstract form) showed significant improvement in only zero, one, and three of the eight Short Form-36 scales, respectively24,25 ( Toozs-Hobson P, Kelleher CJ, Cardozo LD. A longitudinal study of the effect of darifenacin on the quality of life [abstract]. International Continence Society 26th Annual Meeting, Athens, 1996:411–3; Foote AJ, Moore KH. Colposuspension: Impact on quality of life [abstract]. Int Urogynecol J 1997;8:84). In those studies all efficacy indices other than the Short Form-36 score showed significant improvements. We conclude that the Short Form-36 questionnaire is not sensitive enough to document changes in incontinent patients, and it might not be the instrument to use in intervention studies. Incontinence-specific quality-of-life questionnaires rather than generic quality-of-life questionnaires are very important to assess treatment outcomes. Treatment over a longer period might have allowed for more effect on the general measures. A few other studies with surgical and nonsurgical treatments for incontinent women showed significant improvement on the incontinence-related quality-of-life questionnaire used.17,26,27 Other studies with surgical and nonsurgical treatments for incontinent women showed the same significant improvements in an incontinence-related quality-of-life questionnaire ( Toozs-Hobson P, et al. International Continence Society 26th Annual Meeting, Athens, 1996: 411–3; Foote AJ, et al. Int Urogynecol J 1997;8:84; and Versi E, Griffiths DJ. Clinical use of the femassist device in female urinary incontinence [abstract]. International Continence Society 26th Annual Meeting, Athens, 1996: 468).
High effects in the Incontinence Impact Questionnaire scores were correlated with high severity of incontinence, which is in accordance with other quality-of-life studies.5,6 No other characteristics tested were correlated with the Incontinence Impact Questionnaire scores in this study. Earlier studies showed urge incontinence and young age correlated to high effect in quality-of-life scores.2,5,6
It was not possible to predict which women would have successful treatment with the device. The women initially most unsatisfied (content rating of untreated condition) and those most troubled from their symptoms (overall troublesomeness) often wanted to continue using the device, probably because they were more motivated for treatment. Treatment results showed no differences in age, type of incontinence, hormone replacement status, previous hysterectomy, findings at the pelvic examination (descensus or atrophy), leakage at pad weighing test, number of incontinence episodes in voiding diary, discomfort during test period, size of device used, and Incontinence Impact Questionnaire scores.
|
Footnotes |
|---|
Received May 7, 1998. Received in revised form August 17, 1998. Accepted August 27, 1998.
|
References |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
2. Hunskaar S, Vinsnes A. The quality of life in women with urinary incontinence as measured by the sickness impact profile. J Am Geriatr Soc 1991;39:378–82.[Medline]
3. Grimby A, Milsom I, Molander U, Wiklund I, Ekelund P. The influence of urinary incontinence on the quality of life of elderly women. Age Ageing 1993;22:82–9.
4. Norton PA, MacDonald LD, Sedgwick PM, Stanton SL. Distress and delay associated with urinary incontinence, frequency and urgency in women. BMJ 1988;297:1187–9.
5. Wyman JF, Harkins SW, Choi SC, Taylor JR, Fantl JA. Psychosocial impact of urinary incontinence in women. Obstet Gynecol 1987;70: 378–81.[Abstract]
6. Vinsnes AG, Hunskaar S. Distress associated with urinary incontinence, as measured by a visual analogue scale. Scand J Caring Sci 1991;1:57–61.
7. Wiklund I. Factors of importance when evaluating quality of life in clinical trials. Controlled Clin Trials 1990;11:169–79.[Medline]
8. Thyssen H, Lose G. New disposable vaginal device (Continence Guard) in the treatment of female stress incontinence. Acta Obstet Gynecol Scand 1996;75:170–3.[Medline]
9. Biswas N, Spencer P, King J. Conservative management of stress incontinence with a bladder neck support prosthesis. Neurourol Urodyn 1993;12:311–3.
10. Suarez GM, Baum NH, Jacobs J. Use of a standard contraceptive diaphragm in management of stress urinary incontinence. Urology 1991;37:119–22.[Medline]
11. Davila GW, Ostermann KV. The bladder neck support prosthesis: A nonsurgical approach to stress incontinence in adult women. Am J Obstet Gynecol 1994;171:206–11.[Medline]
12. Kondo A, Yokoyama E, Koshiba K, Fukui J, Gotoh M, Yoshikawa Y, et al. Bladder neck support prosthesis: A nonoperative treatment for stress or mixed urinary incontinence. J Urol 1997;157: 824–7.[Medline]
13. Hahn I, Milsom I. Treatment of female stress urinary incontinence with a new anatomically shaped vaginal device (Conveen Continence Guard). Br J Urol 1996;77:711–5.[Medline]
14. Thyssen H, Lose G. Long term efficacy and safety of a disposable vaginal device (Continence Guard) in the treatment of female stress incontinence. Int Urogynecol J 1997;8:130–3.
15. Lose G, Versi E. Pad-weighing tests in the diagnosis and quantification of incontinence. Int Urogynecol J 1992;3:324–8.
16. Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract function. Int Urogynecol J 1990;1:45–58.
17. Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: The Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Quality Life Res 1994;3:291–306.
18. Sprangers MAG, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European organization for research treatment of cancer approach to quality of life assessment: Guidelines for developing questionnaire modules. Quality Life Res 1993;2:287–95.
19. Bernstein I, Sejr T, Abel I, Andersen JT, Fischer-Rasmussen W. Assessment of lower urinary tract symptoms in women by a self-administered questionnaire: Test–retest reliability. Int Urogynecol J 1996;7:37–47.
20. Stewart AL, Hays RD, Ware JE. The MOS Short Form general health survey. Med Care 1988;26:724–35.[Medline]
21. Bjorner JB, Damsgaared MT, Watt T, Groenvold M. Test of data quality, scaling assumptions, and reliability of the Danish SF-36. J Clin Epidemiol 1998;51:1001–11.[Medline]
22. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health survey manual and interpretation guide. Boston, Massachusetts: New England Medical Center, Health Institute, 1993.
23. Lindahl F, Prien Larsen JC, Ballan A, Burchardt F, Prag J. Acceptability and microbiological findings using the colostomy plug system. Surg Res Commun 1990;8:235–40.
24. Sand PK, Richardson DA, Staskin DR, Swift SE, Appell RA, Whitmore KE, et al. Pelvic floor electrical stimulation in the treatment of genuine stress incontinence: A multicenter, placebo-controlled trial. Am J Obstet Gynecol 1995;173:72–9.[Medline]
25. Statskin D, Bavendam T, Miller J, Davila GW, Diokno A, Knapp P, et al. Effectiveness of a urinary control insert in the management of stress urinary incontinence: Early results of a multicenter study. Urology 1996;47:629–36.[Medline]
26. Lee PS, Reid DW, Saltmarche A, Linton L. Measuring the psychosocial impact of urinary incontinence: The York Incontinence Perceptions Scale (YIPS). J Am Geriatr Soc 1995;43:1275–8.[Medline]
27. Wyman JF, Fantl JA, McClish DK, Harkins SW, Uebersax JS, Ory MG. Quality of life following bladder training in older women with urinary incontinence. Int Urogynecol J 1997;8:223–9.
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
