- Email: [email protected]
A new external urethral occlusive device for female urinary incontinence
A New External Urethral Occlusive Device for Female Urinary Incontinence EBOO VERSI, MD, PhD, DAVID J. GRIFFITHS, MD, AND MARIE-ANDRE´E HARVEY, MD Objective: Determine the efficacy of a new external antiincontinence urethral device. Methods: A before-after 1 month trial, open longitudinal study of 155 women complaining of urinary incontinence recruited from a referral urogynecology practice and local media advertising was performed. Primary outcomes included assessing the efficacy of the device using visual analogue scales, quality-of-life questionnaires, 1- and 48hour standardized pad tests, and voiding diary. Secondary outcomes consisted of the evaluation of the adverse effects and the clinical profile of patients willing to use the device after study completion. Results: Ninety-six (62%) of 155 women enrolled completed the study. Scores on the visual analogue scales improved for the symptoms of stress incontinence, urgency, and urge incontinence (P < .001). The score for irritation/discomfort increased (P < .001). Data from diaries showed that 38 (44%, n 5 86) patients were dry. Of 454 recorded patient-days, 325 (72%) were dry days. On pad testing, incontinence was cured in 49% (1-hour pad test, n 5 59, P < .001) and 44% (48-hour pad test, n 5 32, P < .001) of patients. Quality-of-life scores were significantly improved in 48% (n 5 96, Incontinence Impact Questionnaire, P < .001) and 32% (n 5 96, Urogenital Distress Inventory, P < .001) of patients. There was no increase in bacteriuria. After study completion, 61 (39%) women chose to continue using the device, but this was not predictable from baseline data. Conclusion: Use of this device resulted in a significant reduction in incontinence and improvement in quality-oflife issues with minimal adverse events in the majority of women. This new anti-incontinence device could become a useful addition to the armamentarium of nonsurgical options. (Obstet Gynecol 1998;92:286 –91. © 1998 by The American College of Obstetricians and Gynecologists.)
From the Division of Urogynecology, Department of Obstetrics and Gynecology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts. The authors acknowledge the Royal College of Obstetricians and Gynaecologists, London, England, for a Wellbeing grant and Insight Medical, Bolton, Massachusetts, for financial support.
286 0029-7844/98/$19.00 PII S0029-7844(98)00165-3
Female urinary incontinence is a common and debilitating problem for about 10 –30% of women.1,2 Currently, conservative forms of therapy include pelvicfloor muscle re-education with biofeedback,3 behavioral therapy,4 electrical myostimulation,5 and, occasionally, medical therapy.6 Surgery is the other management option. Pelvic-floor muscle re-education, however, is not without cost. The time expended by the caregiver involved in educating the patient and the losses due to poor patient compliance must be considered.7 Side effects and lack of significant effect limit medical therapy. Surgery, although often successful, is not without considerable morbidity and complication8 and indications are commonly for genuine stress incontinence. The American Agency of Health Care Policy and Research has recommended that nonsurgical management be the first line of treatment for genuine stress incontinence.9 With the increasing cost of health care (the total direct cost of incontinence in the United States is estimated to be $16.4 billion per annum in 1994)10 and heightened budget awareness among third-party payers, there is a demand for cost-effective, noninvasive conservative therapeutic approaches to incontinence. Recently there has been a renewed interest in conservative therapeutic measures with the advent of disposable anti-incontinence devices.11 The US Food and Drug Administration has approved the reusable external urethral occlusive devices such as FemAssist (Apple/Insight Medical Corp., Bolton, MA) (Figure 1) and CapSure (Bard, Covington, GA) for use on patients with stress urinary incontinence. These devices are noninvasive, supple silicon-domed caps that fit over the external urethral meatus. They are held
Financial Disclosure Dr. Versi has received honoraria from Insight Medical Corp. for speaking on the use of the device.
Obstetrics & Gynecology
Figure 1. Photograph of the FemAssist device.
in place by a small amount of suction and an ointment that ensures a watertight seal. The devices are nonsterile and reusable, and each can be used for a week. The goals of this study were to evaluate the clinical subjective and objective efficacy of the device, document the presence of adverse effects, and profile women most likely to continue using the device after completion of the 1-month study.
Materials and Methods With advertising in the local press and recruitment from a referral urogynecology unit, 155 women were enrolled in the study. All ambulatory women with symptoms of urinary incontinence were considered for the study. Women who were pregnant or had recently given birth, those with urinary tract infections, those presently undergoing treatment for urinary incontinence, and patients with other debilitating medical conditions were excluded. The FemAssist device has a durometer value of 10 that ensures a supple product. For this study we used two different-sized devices: The regular size is 3 cm in diameter and 2.5 cm in height, and the petite size is 0.5 cm smaller in each dimension. Patients were allowed to choose the size. Aquaphor ointment (Beiersdorf Inc., Norwalk, CT), a healing ointment, was smeared on the flanges of the device prior to placement over the external urethral meatus to ensure a watertight seal. At the initial visit, a history was taken, the study explained, and the consent form was signed. Other assessments consisted of visual analogue scales for severity of symptoms and quality-of-life questionnaires (the long form of Incontinence Impact Questionnaire
VOL. 92, NO. 2, AUGUST 1998
and Urogenital Distress Inventory).12 For the quality-oflife questionnaires, the higher the score recorded, the greater the impairment on quality of life or distress caused by incontinence; the maximum score was 90 for the Incontinence Impact Questionnaire and 57 for the Urogenital Distress Inventory. Visual analogue scales graded the symptoms of stress incontinence, urgency, urge incontinence, and urethral discomfort and irritation. For each symptom a straight ungraduated line of 10 cm in length was labeled “no problem” at one end and “severe problem” at the other. These corresponded to the scores “0” and “10,” respectively, with a higher score representing a greater problem. The patient was asked to mark the line as to where she perceived her problem for each of the four symptoms. At the follow-up visit, patients did not have access to information on these charts and questionnaires. A mid-stream sample of urine was taken from each patient for culture and sensitivity at the first visit. If the culture was found to be positive, the patient was treated and the urine sample was repeated to ensure its sterility before entry into the trial. Patients went home after the first visit with instructions on how to perform a 48-hour pad test.13 The pads were returned in self-sealing bags at the second visit. On the second visit (day 3–7), each patient underwent a physical examination (evaluating for presence of pelvic organ prolapse, atrophy, urethral anomaly, pelvic mass, and demonstration of urinary incontinence), a 1-hour standardized pad test,14 and an instructive demonstration on the use of the device. Pad tests were not performed while the women were menstruating. Patients were shown how to apply and remove the device and were given an opportunity to practice while supervised by a nurse. Using simplified illustrations, patients were instructed on topographic anatomy of the external genitalia. With the use of a mirror, the correct position for placement of the device was demonstrated. Patients also were encouraged to attend the clinic for further help if difficulty was experienced with device fitting. They were encouraged to wear the device when required and were told they may experience initial discomfort, which would improve. Patients were asked to fill out a diary during the 4th week of the study, documenting the number of days the device was worn, the number of dry days, and whether they experienced irritation when wearing the device. They also were asked to record their satisfaction, comfort, and convenience scores (range 0 –5: 5 5 maximum benefit). Finally, they were asked to repeat the 48-hour pad test at home during the use of the FemAssist device. On the final visit (approximately day 30), patients returned to complete further Incontinence Impact and
Versi et al
Urethral Continence Device
287
Table 1. Reasons for Late Drop Out
Table 2. Demographic Data of the Study Population
Reason given
Number of patients
Characteristic
Inconvenient use Irritation from device Inefficacy Unrelated acute medical illness Study schedule too demanding Difficult placement Undergoing anti-incontinence surgery Lost to follow-up No reason given Symptoms of urinary tract infection (lost to follow-up for urine culture) Spontaneous resolution of incontinence Other (memory loss, moving out of study area)
8 5 4 3 2 2 1 4 2 1
Incontinence type (clinical diagnosis) Mixed Urge Stress Occupation Retired Professional Clerical/Manual Unemployed Unknown Menopausal status Premenopausal Postmenopausal Not on ERT On ERT Past surgery Hysterectomy Burch, MMK Needle suspension Anterior repair Smoking Prolapse (any degree) Cystocele Rectocele Apical prolapse
1 2
Urogenital Distress Inventory questionnaires and visual analogue scales with reference to device use. A physical examination of the external genitalia was performed to elicit any signs of device-related trauma. The 1-hour standardized pad test was repeated with the device in situ, and the pads from the 48-hour pad test were collected and weighed. A further mid-stream urine specimen was taken for culture and sensitivity. If the patient found the device to be of any benefit, she was given the opportunity to continue using the device after the end of the trial month. Data were analyzed using a two-tailed paired t test, Pearson correlation coefficient, and x2 analyses as appropriate. When incomplete data were collected, the exact number of patients in the analysis is indicated in parentheses. Prior approval from the Institutional Review Board of the Brigham and Women’s Hospital was obtained. All terms used conform to the standardization and terminology committee classification of the International Continence Society14 unless otherwise stated.
Results One hundred fifty-five women were enrolled in the study. Twenty-four women decided not to participate in the study following their initial visit and were never given the device to try at home. Thirty-five patients dropped out of the study while trying the device at home, and the reasons given for this are presented in Table 1. Ninety-six of 155 enrolled (62%) or 96 of 131 (73%) women who tried the device completed the protocol. Demographic information about the study population is presented in Table 2. Fifty-four patients (56%) used the regular device, and 41 (43%) used the petite device. The size was not specified in one patient. The average age was 54.5 years, standard deviation (SD)
288 Versi et al
Urethral Continence Device
n
%
48 9 39
50 9 41
17 54 8 12 4
18 56 8 13 4
36 60 20 40 32 11 8 10 3 11
38 62 21 42 33 12 8 10 3 12
61 30 25
64 31 26
ERT 5 estrogen replacement therapy; MMK 5 Marshall-MarchettiKrantz. Column 2 indicates the number of patients having the characteristic. Column 3 indicates the percentage of women from the population having the characteristic (except for estrogen replacement therapy, for which the denominator is the number of postmenopausal patients). The percentages are rounded to the nearest whole number.
611.7. The average total parity (6SD) was 2.2 6 1.7 and for vaginal parity, 2.1 6 1.7. The mean body mass index (6SD) was 26 6 8.1. Analysis of data is presented in Table 3. For some patients, the data collected were incomplete. When this was the case, the number of patients having completed Table 3. Predevice and Postdevice Results of the Subjective and Objective Data
VAS (symptoms) (max 5 10, n 5 96) Stress incontinence Urge incontinence Urgency Irritation or discomfort IIQ (max 5 90, n 5 96) UDI (max 5 57, n 5 96) 1 h pad test (n 5 95) 48 h pad test (n 5 49)
Predevice mean (SD)
Postdevice mean (SD)
P
6.0 (2.6) 4.0 (2.7) 4.0 (2.8) 1.4 (2.2) 28.5 (19.0) 16.1 (7.0) 26.9 g (41.1 g) 107.2 g (223.0 g)
3.4 (2.4) 2.8 (2.3) 3.0 (2.5) 2.8 (2.4) 14.7 (18.0) 11.0 (6.5) 9.4 g (24.6 g) 77.5 g (242.2 g)
,.001 ,.001 ,.001 ,.001 ,.001 ,.001 ,.001 NS
SD 5 standard deviation; VAS 5 visual analogue scale; IIQ 5 incontinence impact questionnaire; UDI 5 urogenital distress inventory, max 5 maximum score obtainable; NS 5 not significant.
Obstetrics & Gynecology
that part of the study is indicated in brackets. There was a highly significant decrease in the mean visual analogue scores for the symptoms of stress incontinence, urgency, and urge incontinence (P , .001) and an increase in urethral irritation (P , .001). Quality-of-life scores improved significantly (n 5 96, P , .001) with the mean Incontinence Impact Questionnaire scores decreasing by 48% and Urogenital Distress Inventory decreasing by 32%. A greater than 50% improvement was noted on the Incontinence Impact Questionnaire by 57 (59%) women compared with 32 (33%) women on the Urogenital Distress Inventory. Data from the patients’ diaries (n 5 86) showed that 38 (44%) were totally dry with the device, and of 454 recorded patient days, 325 (72%) were dry days. Satisfaction, convenience, and comfort were rated 3.3, 3.2, and 3.2, respectively, on a scale of 1–5. There was a mean decrease in urine loss on the 1-hour pad test (P , .001) but not in the 48-hour pad test when the test was repeated with the device in situ (Table 3). The change in the 1-hour pad weight (initial pad weight minus final pad weight) correlated with the initial pad weight (r 5 .84). This implies that the decrease in incontinence was proportionate to its severity, ie, patients with more severe leakage had a greater reduction in their pad weights. Hence, pad weights also were analyzed as a percentage change from baseline rather than absolute change as the latter would bias the results, weighting them for the more incontinent patients. Forty-seven patients (49%) had 90 –100% improvement in their 1-hour pad weight. Of the 59 women who had an initial 1-hour pad weight greater than 2 g, 29 (49%) were objectively dry (pad test less than 2 g) with the device on the repeat 1-hour pad test (P , .001, x2 5 43.6). Forty-nine patients (51%) completed the 48-hour pad test, and 32 of these had a positive 48-hour pad test (greater than 15 g) prior to using the device. With the device in place, 14 (44%) were dry (pad test less than 15 g, P , .001, x2 5 17.9). Because this device is approved for use in patients with stress incontinence, we investigated the subjective and objective improvement rate in that subgroup of the study population (n 5 39). The quality-of-life questionnaires showed a significant reduction in scores: The average (6SD) score for the Incontinence Impact Questionnaire initially was 23.7 6 15.0 compared with 11.8 6 15 during use of the device (P , .001), and the average (6SD) score for the Urogenital Distress Inventory initially was 13.0 6 6.0 compared with 8.1 6 5.3 (P , .001). A greater than 50% improvement was noted in 26 (67%) and 15 (39%), respectively, for these questionnaires. The visual analogue scale for stress incontinence showed a significant improvement from an average (6SD) score of 6.6 6 2.2 down to 3.6 6 2.6 (P , .001). The initial
VOL. 92, NO. 2, AUGUST 1998
1-hour pad test was positive (more than 2 g) in 27 patients. Of these, 17 (63%) had a negative pad test (less than 2 g) on the repeat test with the device positioned over the urethra. The mean (6SD) pad weight changed from 24.0 6 41.3 to 9.25 6 28.8 (P , .05). No conclusive data could be drawn from the 48-hour pad test as only 22 patients in this subgroup performed it. After finishing the month trial, 61 women (64%) were interested in continuing to use the device. To obtain a profile of these women, we looked at the initial patient data to determine if it was possible to predict who was likely to want to continue using the device. We compared each variable individually but none was found significantly different between the two groups (continue compared with discontinue). Of the 86 patients who completed a diary, 19 (22%) women reported some irritation or discomfort during the 4th week, which improved spontaneously with discontinuation of the device. However, despite their reported irritation, 10 (53%) of these patients chose to continue to use the device at the end of the study. Adverse events included one symptomatic urinary tract infection and three cases of asymptomatic bacteriuria (more than 105 single growth organisms per milliliter) following a month’s use of the device compared with four cases of bacteriuria prior to the start of the study. One patient had symptoms of urinary tract infection during the study but dropped out and was lost to follow-up; we were unable to obtain a urine culture. Two women had urethral mucosal prolapse (one of them had it prior to use of the device) that resolved spontaneously after discontinuing use of the device for a period of 10 –14 days. Two blood blisters were seen, one due to incorrect placement of the device and the other following trimming of the device to achieve a better fit. Patients reported that the device became easier to place and use after an initial 1-week period of acclimatization. All patients were able to reuse the device several times during a week; some patients used it longer. The manufacturers recommend that the device be changed after 1 week of use.
Discussion Our data indicate that use of this novel antiincontinence device is safe and effective in the 62% of patients who completed the protocol. The goals of this study were to evaluate efficacy and to determine for which patients this device would be suitable. For that reason, the inclusion criteria were broad, and the exclusion criteria were minimal. The authors envisaged that this device would be used as a first-line treatment; consequently, the study design did
Versi et al
Urethral Continence Device
289
not require a urodynamic diagnosis. However, an objective assessment (pad test) was made because it is well recognized that subjective improvement often exceeds objective improvement. Also, the presence of objective data makes inclusion of a control group in this study design nonessential. Subjective cure rate based on diary data was 44% (38 of 86), and objective cure rates were 49% and 44% for the 1-hour and 48-hour pad test, respectively. These figures are interesting because they do not show a discrepancy between subjective and objective data and are impressive when compared with the success of other noninvasive modalities. Most studies on pelvicfloor muscle exercises yield a cure rate of only about 30% when performed in the standard manner (instruction, control and feedback by palpation and visual assessment, home exercise, and monthly assessment and motivation).15 Only when the exercises are intensive15 (weekly 45-minute visit with instructor, strong verbal encouragement during each contraction) do pelvic-floor muscle exercises yield a better result of about 60% cure as per the International Continence Society criteria (conversion of a negative stress urethral closure profile to a positive one after treatment).15 There did not appear to be an increase in bacteriuria rate, and the local irritation rate was relatively low. However, despite its low incidence, urethral mucosal prolapse and blister formation should be investigated in future studies with longer follow-up periods. As this device stays in place by exerting a minor suction, it is possible that in susceptible individuals the suction could lead to urethral mucosal prolapse. Also, we believe that a history of urethral mucosal prolapse and severe atrophic vulvo-vaginitis should be relative contraindications for use of the device. This study was not designed to assess long-term use, and more data on this issue are needed before we can recommend this device for widespread usage. An intervention may be highly successful within the confines of a controlled study but yields disappointing results subsequently when subjected to widespread usage. Thus analysis of dropouts is important in the assessment of efficacy as well as in the assessment of the characteristics of those who continue to use the device after the trial has ended. An analysis based on intention to treat all patients (n 5 145, excluding 10 patients who were definitively study-design–related dropouts), yielded a 26% (38 of 145) subjective cure (dry) rate by diary analysis with an additional proportion of patients who were improved. Also, 42% (61 of 145) of patients introduced to the device were willing to continue using it, reflecting their improvement in quality of life. We consider that about a third of patients being dry and having their quality of life significantly improved rep-
290 Versi et al
Urethral Continence Device
resents promising results for a potential first-line noninvasive therapy. However, long-term studies are needed to substantiate this initial impression. It was not possible with this study to define the characteristics of those for whom the device would be more suitable; age and type of incontinence did not appear to matter. A proportion of women of all ages with all types of incontinence found the device suitable. Intraurethral meatus occlusive devices, such as Reliance (UroMed Corp., Needham, MA) (Pigne´ A, Bitker MO, Cotelle-Berne`de O, Gautheraon V, Jacquetin B, Labat JJ, et al. Reliance urinary control insert: Results of a French multicenter study [abstract]. Int Urogynecol J 1997;8:S128) and the urethral plug,16,17 have been developed, but there are concerns that such devices may cause urethral trauma and urinary tract infection. An occlusive device that is not inserted into the urethra may offer convenience and efficacy with minimal trauma. Only one other external occlusive device has been developed18 that also has shown a safe and efficacious profile. However, this device needs to be changed after each void because it loses its adhesiveness, whereas the FemAssist and CapSure are reusable and thus may decrease costs because they rely on negative pressure rather than on an adhesive layer.
References 1. Burgio KL, Matthews KA, Engel BT. Prevalence, incidence and correlates of urinary incontinence in healthy middle-aged women. J Urol 1991;146:1255–9. 2. Diokno AC, Brock BM, Brown MB, Herzog AR. Prevalence of urinary problems and other urological symptoms in the noninstitutionalized elderly. J Urol 1986;136:1022–5. 3. Wise B. Physiotherapy. In: Cardozo L, ed. Urogynecology. New York: Churchill Livingstone, 1997:583–93. 4. Tapp A. Behavioral therapy. In: Cardozo L, ed. Urogynecology. New York: Churchill Livingstone, 1997:595– 602. 5. Wise B. Electrical therapy. In: Cardozo L, ed. Urogynecology. New York: Churchill Livingstone, 1997:603–12. 6. Fantl JA, Newman DK, Colling J, DeLancey JOL, Keeys C, Loughery R, et al. Urinary incontinence in adults: Acute and chronic management. Clinical Practice Guideline, No 2, 1996 Update. Rockville, MD: US Department of Health and Human Services. Public Health Service, Agency for Health and Human Services. Public Health Services, Agency for Health Care Policy and Research. AHCPR Publication No. 96-0682. March 1996:43–51. 7. Mantle JM, Versi E. Physiotherapy for stress incontinence: A national survey. BMJ 1991;302:753–5. 8. Stanton SL. Surgical management of urethral sphincter incompetence. In: Norton PA, ed. Clinical obstetrics and gynaecology. Philadelphia: Lippincott Co, 1990;346 –57. 9. US Department of Health and Human Services, Public Health Service. Agency for Health Care Policy and Research. Urinary Incontinence Guideline Panel. Urinary incontinence in adults: Clinical practice guideline. AHCPR Publication No. 92-0038. Rockville, MD. March 1992:27. 10. Hu T, Gabelko K, Weis KA, Fogarty TE, Diokno AC, McCormick
Obstetrics & Gynecology
11.
12.
13.
14.
15.
16.
KA. Clinical guidelines and cost implications—The case of urinary incontinence. Geriatr Nephrol Urol 1994;4:8 –91. Staskin 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. 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. Qual Life Res 1994;3:291–306. Versi E, Orrego G, Hardy E, Seddon G, Smith P, Anand D. Evaluation of the home pad test in the investigation of female urinary incontinence. Br J Obstet Gynaecol 1996;103:162–7. Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract function. Br J Obstet Gynaecol 1990;97 Suppl 6:1–16. Bø K. Clinical results: Isolated muscle exercise. In: Schu¨ssler B, Laycock J, Norton P, Stanton S, eds. Pelvic floor re-education: Principles and practice. London: Springer-Verlag, 1994, 159. Nielsen KK, Walter S, Maeggaard E, Kromann-Andersen B. The urethral plug II: An alternative treatment in women with genuine urinary stress incontinence. Br J Urol 1993;72:428 –32.
VOL. 92, NO. 2, AUGUST 1998
17. Abrams P. Management of lower urinary tract dysfunction. In: Abrams P, ed. Urodynamics. London: Springer-Verlag, 1997:177. 18. Harris T, Gleason D, Diokno A, Norton P. External urethral barrier for urinary stress incontinence: A multi-center trial. Neurourol Urodynam 1994;13:381–2.
Address reprint requests to:
Eboo Versi, MD, PhD Department of Obstetrics and Gynecology Harvard Medical School 500 Brookline Avenue, Suite E Boston, MA 02215
Received November 19, 1997. Received in revised form March 12, 1998. Accepted March 19, 1998. Copyright © 1998 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
Versi et al
Urethral Continence Device
291
From the Division of Urogynecology, Department of Obstetrics and Gynecology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts. The authors acknowledge the Royal College of Obstetricians and Gynaecologists, London, England, for a Wellbeing grant and Insight Medical, Bolton, Massachusetts, for financial support.
286 0029-7844/98/$19.00 PII S0029-7844(98)00165-3
Female urinary incontinence is a common and debilitating problem for about 10 –30% of women.1,2 Currently, conservative forms of therapy include pelvicfloor muscle re-education with biofeedback,3 behavioral therapy,4 electrical myostimulation,5 and, occasionally, medical therapy.6 Surgery is the other management option. Pelvic-floor muscle re-education, however, is not without cost. The time expended by the caregiver involved in educating the patient and the losses due to poor patient compliance must be considered.7 Side effects and lack of significant effect limit medical therapy. Surgery, although often successful, is not without considerable morbidity and complication8 and indications are commonly for genuine stress incontinence. The American Agency of Health Care Policy and Research has recommended that nonsurgical management be the first line of treatment for genuine stress incontinence.9 With the increasing cost of health care (the total direct cost of incontinence in the United States is estimated to be $16.4 billion per annum in 1994)10 and heightened budget awareness among third-party payers, there is a demand for cost-effective, noninvasive conservative therapeutic approaches to incontinence. Recently there has been a renewed interest in conservative therapeutic measures with the advent of disposable anti-incontinence devices.11 The US Food and Drug Administration has approved the reusable external urethral occlusive devices such as FemAssist (Apple/Insight Medical Corp., Bolton, MA) (Figure 1) and CapSure (Bard, Covington, GA) for use on patients with stress urinary incontinence. These devices are noninvasive, supple silicon-domed caps that fit over the external urethral meatus. They are held
Financial Disclosure Dr. Versi has received honoraria from Insight Medical Corp. for speaking on the use of the device.
Obstetrics & Gynecology
Figure 1. Photograph of the FemAssist device.
in place by a small amount of suction and an ointment that ensures a watertight seal. The devices are nonsterile and reusable, and each can be used for a week. The goals of this study were to evaluate the clinical subjective and objective efficacy of the device, document the presence of adverse effects, and profile women most likely to continue using the device after completion of the 1-month study.
Materials and Methods With advertising in the local press and recruitment from a referral urogynecology unit, 155 women were enrolled in the study. All ambulatory women with symptoms of urinary incontinence were considered for the study. Women who were pregnant or had recently given birth, those with urinary tract infections, those presently undergoing treatment for urinary incontinence, and patients with other debilitating medical conditions were excluded. The FemAssist device has a durometer value of 10 that ensures a supple product. For this study we used two different-sized devices: The regular size is 3 cm in diameter and 2.5 cm in height, and the petite size is 0.5 cm smaller in each dimension. Patients were allowed to choose the size. Aquaphor ointment (Beiersdorf Inc., Norwalk, CT), a healing ointment, was smeared on the flanges of the device prior to placement over the external urethral meatus to ensure a watertight seal. At the initial visit, a history was taken, the study explained, and the consent form was signed. Other assessments consisted of visual analogue scales for severity of symptoms and quality-of-life questionnaires (the long form of Incontinence Impact Questionnaire
VOL. 92, NO. 2, AUGUST 1998
and Urogenital Distress Inventory).12 For the quality-oflife questionnaires, the higher the score recorded, the greater the impairment on quality of life or distress caused by incontinence; the maximum score was 90 for the Incontinence Impact Questionnaire and 57 for the Urogenital Distress Inventory. Visual analogue scales graded the symptoms of stress incontinence, urgency, urge incontinence, and urethral discomfort and irritation. For each symptom a straight ungraduated line of 10 cm in length was labeled “no problem” at one end and “severe problem” at the other. These corresponded to the scores “0” and “10,” respectively, with a higher score representing a greater problem. The patient was asked to mark the line as to where she perceived her problem for each of the four symptoms. At the follow-up visit, patients did not have access to information on these charts and questionnaires. A mid-stream sample of urine was taken from each patient for culture and sensitivity at the first visit. If the culture was found to be positive, the patient was treated and the urine sample was repeated to ensure its sterility before entry into the trial. Patients went home after the first visit with instructions on how to perform a 48-hour pad test.13 The pads were returned in self-sealing bags at the second visit. On the second visit (day 3–7), each patient underwent a physical examination (evaluating for presence of pelvic organ prolapse, atrophy, urethral anomaly, pelvic mass, and demonstration of urinary incontinence), a 1-hour standardized pad test,14 and an instructive demonstration on the use of the device. Pad tests were not performed while the women were menstruating. Patients were shown how to apply and remove the device and were given an opportunity to practice while supervised by a nurse. Using simplified illustrations, patients were instructed on topographic anatomy of the external genitalia. With the use of a mirror, the correct position for placement of the device was demonstrated. Patients also were encouraged to attend the clinic for further help if difficulty was experienced with device fitting. They were encouraged to wear the device when required and were told they may experience initial discomfort, which would improve. Patients were asked to fill out a diary during the 4th week of the study, documenting the number of days the device was worn, the number of dry days, and whether they experienced irritation when wearing the device. They also were asked to record their satisfaction, comfort, and convenience scores (range 0 –5: 5 5 maximum benefit). Finally, they were asked to repeat the 48-hour pad test at home during the use of the FemAssist device. On the final visit (approximately day 30), patients returned to complete further Incontinence Impact and
Versi et al
Urethral Continence Device
287
Table 1. Reasons for Late Drop Out
Table 2. Demographic Data of the Study Population
Reason given
Number of patients
Characteristic
Inconvenient use Irritation from device Inefficacy Unrelated acute medical illness Study schedule too demanding Difficult placement Undergoing anti-incontinence surgery Lost to follow-up No reason given Symptoms of urinary tract infection (lost to follow-up for urine culture) Spontaneous resolution of incontinence Other (memory loss, moving out of study area)
8 5 4 3 2 2 1 4 2 1
Incontinence type (clinical diagnosis) Mixed Urge Stress Occupation Retired Professional Clerical/Manual Unemployed Unknown Menopausal status Premenopausal Postmenopausal Not on ERT On ERT Past surgery Hysterectomy Burch, MMK Needle suspension Anterior repair Smoking Prolapse (any degree) Cystocele Rectocele Apical prolapse
1 2
Urogenital Distress Inventory questionnaires and visual analogue scales with reference to device use. A physical examination of the external genitalia was performed to elicit any signs of device-related trauma. The 1-hour standardized pad test was repeated with the device in situ, and the pads from the 48-hour pad test were collected and weighed. A further mid-stream urine specimen was taken for culture and sensitivity. If the patient found the device to be of any benefit, she was given the opportunity to continue using the device after the end of the trial month. Data were analyzed using a two-tailed paired t test, Pearson correlation coefficient, and x2 analyses as appropriate. When incomplete data were collected, the exact number of patients in the analysis is indicated in parentheses. Prior approval from the Institutional Review Board of the Brigham and Women’s Hospital was obtained. All terms used conform to the standardization and terminology committee classification of the International Continence Society14 unless otherwise stated.
Results One hundred fifty-five women were enrolled in the study. Twenty-four women decided not to participate in the study following their initial visit and were never given the device to try at home. Thirty-five patients dropped out of the study while trying the device at home, and the reasons given for this are presented in Table 1. Ninety-six of 155 enrolled (62%) or 96 of 131 (73%) women who tried the device completed the protocol. Demographic information about the study population is presented in Table 2. Fifty-four patients (56%) used the regular device, and 41 (43%) used the petite device. The size was not specified in one patient. The average age was 54.5 years, standard deviation (SD)
288 Versi et al
Urethral Continence Device
n
%
48 9 39
50 9 41
17 54 8 12 4
18 56 8 13 4
36 60 20 40 32 11 8 10 3 11
38 62 21 42 33 12 8 10 3 12
61 30 25
64 31 26
ERT 5 estrogen replacement therapy; MMK 5 Marshall-MarchettiKrantz. Column 2 indicates the number of patients having the characteristic. Column 3 indicates the percentage of women from the population having the characteristic (except for estrogen replacement therapy, for which the denominator is the number of postmenopausal patients). The percentages are rounded to the nearest whole number.
611.7. The average total parity (6SD) was 2.2 6 1.7 and for vaginal parity, 2.1 6 1.7. The mean body mass index (6SD) was 26 6 8.1. Analysis of data is presented in Table 3. For some patients, the data collected were incomplete. When this was the case, the number of patients having completed Table 3. Predevice and Postdevice Results of the Subjective and Objective Data
VAS (symptoms) (max 5 10, n 5 96) Stress incontinence Urge incontinence Urgency Irritation or discomfort IIQ (max 5 90, n 5 96) UDI (max 5 57, n 5 96) 1 h pad test (n 5 95) 48 h pad test (n 5 49)
Predevice mean (SD)
Postdevice mean (SD)
P
6.0 (2.6) 4.0 (2.7) 4.0 (2.8) 1.4 (2.2) 28.5 (19.0) 16.1 (7.0) 26.9 g (41.1 g) 107.2 g (223.0 g)
3.4 (2.4) 2.8 (2.3) 3.0 (2.5) 2.8 (2.4) 14.7 (18.0) 11.0 (6.5) 9.4 g (24.6 g) 77.5 g (242.2 g)
,.001 ,.001 ,.001 ,.001 ,.001 ,.001 ,.001 NS
SD 5 standard deviation; VAS 5 visual analogue scale; IIQ 5 incontinence impact questionnaire; UDI 5 urogenital distress inventory, max 5 maximum score obtainable; NS 5 not significant.
Obstetrics & Gynecology
that part of the study is indicated in brackets. There was a highly significant decrease in the mean visual analogue scores for the symptoms of stress incontinence, urgency, and urge incontinence (P , .001) and an increase in urethral irritation (P , .001). Quality-of-life scores improved significantly (n 5 96, P , .001) with the mean Incontinence Impact Questionnaire scores decreasing by 48% and Urogenital Distress Inventory decreasing by 32%. A greater than 50% improvement was noted on the Incontinence Impact Questionnaire by 57 (59%) women compared with 32 (33%) women on the Urogenital Distress Inventory. Data from the patients’ diaries (n 5 86) showed that 38 (44%) were totally dry with the device, and of 454 recorded patient days, 325 (72%) were dry days. Satisfaction, convenience, and comfort were rated 3.3, 3.2, and 3.2, respectively, on a scale of 1–5. There was a mean decrease in urine loss on the 1-hour pad test (P , .001) but not in the 48-hour pad test when the test was repeated with the device in situ (Table 3). The change in the 1-hour pad weight (initial pad weight minus final pad weight) correlated with the initial pad weight (r 5 .84). This implies that the decrease in incontinence was proportionate to its severity, ie, patients with more severe leakage had a greater reduction in their pad weights. Hence, pad weights also were analyzed as a percentage change from baseline rather than absolute change as the latter would bias the results, weighting them for the more incontinent patients. Forty-seven patients (49%) had 90 –100% improvement in their 1-hour pad weight. Of the 59 women who had an initial 1-hour pad weight greater than 2 g, 29 (49%) were objectively dry (pad test less than 2 g) with the device on the repeat 1-hour pad test (P , .001, x2 5 43.6). Forty-nine patients (51%) completed the 48-hour pad test, and 32 of these had a positive 48-hour pad test (greater than 15 g) prior to using the device. With the device in place, 14 (44%) were dry (pad test less than 15 g, P , .001, x2 5 17.9). Because this device is approved for use in patients with stress incontinence, we investigated the subjective and objective improvement rate in that subgroup of the study population (n 5 39). The quality-of-life questionnaires showed a significant reduction in scores: The average (6SD) score for the Incontinence Impact Questionnaire initially was 23.7 6 15.0 compared with 11.8 6 15 during use of the device (P , .001), and the average (6SD) score for the Urogenital Distress Inventory initially was 13.0 6 6.0 compared with 8.1 6 5.3 (P , .001). A greater than 50% improvement was noted in 26 (67%) and 15 (39%), respectively, for these questionnaires. The visual analogue scale for stress incontinence showed a significant improvement from an average (6SD) score of 6.6 6 2.2 down to 3.6 6 2.6 (P , .001). The initial
VOL. 92, NO. 2, AUGUST 1998
1-hour pad test was positive (more than 2 g) in 27 patients. Of these, 17 (63%) had a negative pad test (less than 2 g) on the repeat test with the device positioned over the urethra. The mean (6SD) pad weight changed from 24.0 6 41.3 to 9.25 6 28.8 (P , .05). No conclusive data could be drawn from the 48-hour pad test as only 22 patients in this subgroup performed it. After finishing the month trial, 61 women (64%) were interested in continuing to use the device. To obtain a profile of these women, we looked at the initial patient data to determine if it was possible to predict who was likely to want to continue using the device. We compared each variable individually but none was found significantly different between the two groups (continue compared with discontinue). Of the 86 patients who completed a diary, 19 (22%) women reported some irritation or discomfort during the 4th week, which improved spontaneously with discontinuation of the device. However, despite their reported irritation, 10 (53%) of these patients chose to continue to use the device at the end of the study. Adverse events included one symptomatic urinary tract infection and three cases of asymptomatic bacteriuria (more than 105 single growth organisms per milliliter) following a month’s use of the device compared with four cases of bacteriuria prior to the start of the study. One patient had symptoms of urinary tract infection during the study but dropped out and was lost to follow-up; we were unable to obtain a urine culture. Two women had urethral mucosal prolapse (one of them had it prior to use of the device) that resolved spontaneously after discontinuing use of the device for a period of 10 –14 days. Two blood blisters were seen, one due to incorrect placement of the device and the other following trimming of the device to achieve a better fit. Patients reported that the device became easier to place and use after an initial 1-week period of acclimatization. All patients were able to reuse the device several times during a week; some patients used it longer. The manufacturers recommend that the device be changed after 1 week of use.
Discussion Our data indicate that use of this novel antiincontinence device is safe and effective in the 62% of patients who completed the protocol. The goals of this study were to evaluate efficacy and to determine for which patients this device would be suitable. For that reason, the inclusion criteria were broad, and the exclusion criteria were minimal. The authors envisaged that this device would be used as a first-line treatment; consequently, the study design did
Versi et al
Urethral Continence Device
289
not require a urodynamic diagnosis. However, an objective assessment (pad test) was made because it is well recognized that subjective improvement often exceeds objective improvement. Also, the presence of objective data makes inclusion of a control group in this study design nonessential. Subjective cure rate based on diary data was 44% (38 of 86), and objective cure rates were 49% and 44% for the 1-hour and 48-hour pad test, respectively. These figures are interesting because they do not show a discrepancy between subjective and objective data and are impressive when compared with the success of other noninvasive modalities. Most studies on pelvicfloor muscle exercises yield a cure rate of only about 30% when performed in the standard manner (instruction, control and feedback by palpation and visual assessment, home exercise, and monthly assessment and motivation).15 Only when the exercises are intensive15 (weekly 45-minute visit with instructor, strong verbal encouragement during each contraction) do pelvic-floor muscle exercises yield a better result of about 60% cure as per the International Continence Society criteria (conversion of a negative stress urethral closure profile to a positive one after treatment).15 There did not appear to be an increase in bacteriuria rate, and the local irritation rate was relatively low. However, despite its low incidence, urethral mucosal prolapse and blister formation should be investigated in future studies with longer follow-up periods. As this device stays in place by exerting a minor suction, it is possible that in susceptible individuals the suction could lead to urethral mucosal prolapse. Also, we believe that a history of urethral mucosal prolapse and severe atrophic vulvo-vaginitis should be relative contraindications for use of the device. This study was not designed to assess long-term use, and more data on this issue are needed before we can recommend this device for widespread usage. An intervention may be highly successful within the confines of a controlled study but yields disappointing results subsequently when subjected to widespread usage. Thus analysis of dropouts is important in the assessment of efficacy as well as in the assessment of the characteristics of those who continue to use the device after the trial has ended. An analysis based on intention to treat all patients (n 5 145, excluding 10 patients who were definitively study-design–related dropouts), yielded a 26% (38 of 145) subjective cure (dry) rate by diary analysis with an additional proportion of patients who were improved. Also, 42% (61 of 145) of patients introduced to the device were willing to continue using it, reflecting their improvement in quality of life. We consider that about a third of patients being dry and having their quality of life significantly improved rep-
290 Versi et al
Urethral Continence Device
resents promising results for a potential first-line noninvasive therapy. However, long-term studies are needed to substantiate this initial impression. It was not possible with this study to define the characteristics of those for whom the device would be more suitable; age and type of incontinence did not appear to matter. A proportion of women of all ages with all types of incontinence found the device suitable. Intraurethral meatus occlusive devices, such as Reliance (UroMed Corp., Needham, MA) (Pigne´ A, Bitker MO, Cotelle-Berne`de O, Gautheraon V, Jacquetin B, Labat JJ, et al. Reliance urinary control insert: Results of a French multicenter study [abstract]. Int Urogynecol J 1997;8:S128) and the urethral plug,16,17 have been developed, but there are concerns that such devices may cause urethral trauma and urinary tract infection. An occlusive device that is not inserted into the urethra may offer convenience and efficacy with minimal trauma. Only one other external occlusive device has been developed18 that also has shown a safe and efficacious profile. However, this device needs to be changed after each void because it loses its adhesiveness, whereas the FemAssist and CapSure are reusable and thus may decrease costs because they rely on negative pressure rather than on an adhesive layer.
References 1. Burgio KL, Matthews KA, Engel BT. Prevalence, incidence and correlates of urinary incontinence in healthy middle-aged women. J Urol 1991;146:1255–9. 2. Diokno AC, Brock BM, Brown MB, Herzog AR. Prevalence of urinary problems and other urological symptoms in the noninstitutionalized elderly. J Urol 1986;136:1022–5. 3. Wise B. Physiotherapy. In: Cardozo L, ed. Urogynecology. New York: Churchill Livingstone, 1997:583–93. 4. Tapp A. Behavioral therapy. In: Cardozo L, ed. Urogynecology. New York: Churchill Livingstone, 1997:595– 602. 5. Wise B. Electrical therapy. In: Cardozo L, ed. Urogynecology. New York: Churchill Livingstone, 1997:603–12. 6. Fantl JA, Newman DK, Colling J, DeLancey JOL, Keeys C, Loughery R, et al. Urinary incontinence in adults: Acute and chronic management. Clinical Practice Guideline, No 2, 1996 Update. Rockville, MD: US Department of Health and Human Services. Public Health Service, Agency for Health and Human Services. Public Health Services, Agency for Health Care Policy and Research. AHCPR Publication No. 96-0682. March 1996:43–51. 7. Mantle JM, Versi E. Physiotherapy for stress incontinence: A national survey. BMJ 1991;302:753–5. 8. Stanton SL. Surgical management of urethral sphincter incompetence. In: Norton PA, ed. Clinical obstetrics and gynaecology. Philadelphia: Lippincott Co, 1990;346 –57. 9. US Department of Health and Human Services, Public Health Service. Agency for Health Care Policy and Research. Urinary Incontinence Guideline Panel. Urinary incontinence in adults: Clinical practice guideline. AHCPR Publication No. 92-0038. Rockville, MD. March 1992:27. 10. Hu T, Gabelko K, Weis KA, Fogarty TE, Diokno AC, McCormick
Obstetrics & Gynecology
11.
12.
13.
14.
15.
16.
KA. Clinical guidelines and cost implications—The case of urinary incontinence. Geriatr Nephrol Urol 1994;4:8 –91. Staskin 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. 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. Qual Life Res 1994;3:291–306. Versi E, Orrego G, Hardy E, Seddon G, Smith P, Anand D. Evaluation of the home pad test in the investigation of female urinary incontinence. Br J Obstet Gynaecol 1996;103:162–7. Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract function. Br J Obstet Gynaecol 1990;97 Suppl 6:1–16. Bø K. Clinical results: Isolated muscle exercise. In: Schu¨ssler B, Laycock J, Norton P, Stanton S, eds. Pelvic floor re-education: Principles and practice. London: Springer-Verlag, 1994, 159. Nielsen KK, Walter S, Maeggaard E, Kromann-Andersen B. The urethral plug II: An alternative treatment in women with genuine urinary stress incontinence. Br J Urol 1993;72:428 –32.
VOL. 92, NO. 2, AUGUST 1998
17. Abrams P. Management of lower urinary tract dysfunction. In: Abrams P, ed. Urodynamics. London: Springer-Verlag, 1997:177. 18. Harris T, Gleason D, Diokno A, Norton P. External urethral barrier for urinary stress incontinence: A multi-center trial. Neurourol Urodynam 1994;13:381–2.
Address reprint requests to:
Eboo Versi, MD, PhD Department of Obstetrics and Gynecology Harvard Medical School 500 Brookline Avenue, Suite E Boston, MA 02215
Received November 19, 1997. Received in revised form March 12, 1998. Accepted March 19, 1998. Copyright © 1998 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
Versi et al
Urethral Continence Device
291