Treatment of Exercise Incontinence With a Urethral Insert
A Pilot Study in Women
Melissa Dunn, MD; Debra Brandt, RN; Ingrid Nygaard, MD
THE PHYSICIAN AND SPORTSMEDICINE - VOL 30 - NO.1 - JANUARY 2002
OBJECTIVE: This study sought to evaluate the short- and medium-term effectiveness of an intraurethral device (FemSoft Insert, Rochester Medical Corporation, Stewartville, Minnesota) in the treatment of exercise-induced incontinence in women.
DESIGN: An unblinded, controlled trial of device efficacy during supervised exercise sessions (phase 1) was followed by a 3-month uncontrolled trial of device effectiveness (phase 2). The setting was a tertiary care center, and female participants were 6 community adults with symptoms of significant stress incontinence during exercise. Phase 1 consisted of four standardized exercise sessions, two with and two without the insert in place. In phase 2, patients performed unsupervised exercise using the insert during a 3-month period. The main outcome measure was change in urine loss during exercise sessions performed with and without the device, as measured by change in pad weight. Secondary outcome measures were results of satisfaction surveys and occurrence of adverse events.
RESULTS: Median urine loss during standardized exercise sessions decreased from 20 g (range, 4.9 to 80.2 g) without the device to 2.6 g (range, 1.3 to 6.8 g) with the device (P=0.03). Five women used the device at home during unsupervised exercise; one subject had a urinary tract infection. At the end of 3 months, satisfaction and comfort were rated high on a 5-point scale.
CONCLUSION: The FemSoft urethral device is an effective, safe, and comfortable treatment for exercise incontinence in women.
Urinary leakage is a common problem (1) that occurs during exercise in one third of adult women (2). Although the problem is more significant in women who have borne children, as many as 28% of young, nulliparous athletes have reported urine loss while participating in sports (3). While some women manage exercise incontinence by limiting fluid intake before and during exercise, by choosing sports that allow frequent bathroom access, or by wearing absorbent pads, 20% to 40% of women cope with leakage by ceasing to exercise.
There is no universally accepted effective treatment for this common problem (4). Therapies for urine leakage during exercise include pelvic muscle exercises (4), intravaginal devices (5-8), and urethral occlusive devices (9,10). These options are generally effective in women who have only mild urine leakage. Surgery can also be effective in women with more severe incontinence, but patients are often reluctant to undergo an invasive procedure.
This study evaluates a new method for managing exercise incontinence. The FemSoft Insert (Rochester Medical Corporation, Stewartville, Minnesota) is an intraurethral device intended for one-time use to prevent urinary leakage in women with urinary stress incontinence. It consists of a thin cylinder encapsulated in a soft, compressible, mineral oil-filled silicone layer with an insertion probe (figure 1). Before insertion, the fluid distends the proximal end of the cylinder. As the user pushes the device (guided by the insertion probe) into the urethra (figure 2), fluid transfers automatically to the distal end, allowing the device to pass through the urethra. Once in place, fluid flows back to the proximal end to hold the device in place. The insertion probe is then removed.
Our pilot study sought to assess (1) the device's efficacy when worn during supervised exercise sessions, and (2) its effectiveness for exercise incontinence when used without supervision for 3 months.
Materials and Methods
Subject selection. Participants were selected from community volunteers recruited via newspaper advertisements and flyers in recreational facilities. Six women participated; all were white. Mean age was 46 years (range, 35 to 55), and mean body mass index, 25.8 (range, 20.6 to 34.6). Two women were postmenopausal, one perimenopausal, and three premenopausal. All women had had two vaginal and no cesarean deliveries. Two participants had had hysterectomies; one had had an anterior vaginal repair. Pelvic organ prolapse scores among the participants were stage 1 in one, stage 2 in four, and stage 3 in one.
Inclusion criteria included female sex, being older than 18, having stress incontinence during exercise that required pads or clothing changes, being able to perform regular aerobic exercise, and having adequate manual dexterity and intelligence to use the device and complete the subject questionnaires.
Exclusion criteria included primary urgency incontinence, use of pharmacologic agents for bladder dysfunction, microhematuria, three or more urinary tract infections in the previous 12 months or current infection, pregnancy, urethral stricture, immunocompromised status, prosthetic implants, cardiovascular disease, exercise intolerance, prolonged menses (>10 days), and bladder prolapse beyond the introitus with straining. The study was approved by the University of Iowa institutional review board, and the women signed informed consent forms.
Subject examination. Participants were examined before the study began and were assigned a prolapse grading score based on standards recommended by the International Continence Society (11). Before the study, urine was collected for dipstick evaluation (bacteria, hematuria, nitrites, and leukocyte esterase) and bacterial culture. All urine cultures were negative for bacteria.
Exercise regimen and measurements. All but one of the women had given up certain activities because of exercise-induced urine loss. Participant exercise included brisk walking, jogging, running, aerobics, swimming, weight lifting, and bicycling. All participants reported that before the study they had to interrupt exercise sessions to urinate and that they wore pads during exercise. Three subjects had tried available vaginal incontinence devices during exercise, without success.
Four randomly ordered, standardized exercise sessions were scheduled for phase 1 of the study, two with and two without the insert. Investigators placed the inserts. Women wore preweighed incontinence pads while participating in 45-minute aerobic exercise sessions led by a qualified aerobics instructor. Sessions stressed movements known to provoke incontinence. After each session, pads were weighed to the nearest 0.1 g, posttest void volumes measured, and satisfaction questionnaires completed.
If the devices were effective and the subjects wanted to continue using them, they entered phase 2 of the study. One woman who declined had less leakage while wearing the insert, but considered long-term participation too burdensome. The women were trained to insert and remove the device and given a supply. During the next 3 months, participants exercised 20 to 55 times, with sessions lasting between 15 and 180 minutes. Exercise included walking, jogging, farm chores, aerobics, bicycling, and yard work. In this period, 5 participants completed exercise logs that detailed the date, duration, and type of exercise, whether or not a device was used, and whether the device prevented urine loss. All phase-2 subjects completed a final satisfaction survey.
Statistical analyses. Analyses included Wilcoxon signed rank test and Spearman correlation coefficients. The Wilcoxon test measures the difference in median urine loss with and without the device. The Spearman correlation coefficient is used to determine any correlation of the two sessions done with and without the device. Results were considered significant if P<0.05. Satisfaction surveys were tallied and scores averaged.
Phase 1. All women had less urinary leakage while wearing the device. Median urine loss decreased from 20 g [about 20 mL] (range, 4.9 to 80.2 g) in women not wearing the device to 2.58 g [about 2.6 mL]; (range, 1.3 to 6.8 g) in women wearing it (P=0.03). Stage of prolapse did not correlate with amount of urine lost. Because of scheduling constraints, two subjects missed one nondevice session.
The Spearman correlation coefficient of urine loss between sessions without the device was 0.4 and with the device was -0.116; neither were statistically significant. These measures were significantly affected by one outlier value in each group, but, because of the small sample size, the outlier was not removed to recalculate the correlations.
Mean volume voided after exercise was 68 mL in women who wore the device and 89 mL in women who did not. One subject experienced dysuria after the first, but not the second, exercise session with the device in place. Two women experienced occasional urgency, and one had occasional frequency. No woman reported hematuria or device expulsion in stage 1.
Satisfaction surveys completed after exercising with the device revealed that subjects rated comfort as 2.33 during insertion, 2.08 while wearing, and 2.00 during removal (on a 5-point scale, 1 = very comfortable/satisfied, 5 = very uncomfortable/unsatisfied).
Phase 2. During this phase, one woman experienced dysuria and hematuria after difficulty inserting the device during the first week of home use. Her urine culture and dipstick were negative, and symptoms resolved after further use. Another woman with intercourse-related urinary tract infections treated herself with antibiotics for symptoms. One woman expelled the device while doing sit-ups, but had no such problem during aerobics.
Mean satisfaction scores for ease of use were 2.09 for insertion and 1.18 for removal; for comfort, the scores were 2.18 for insertion, 2.05 while wearing, and 1.36 during removal.
Comments from the study subjects at the close of the study included:
In this small pilot study, we found the insert effective and feasible for unsupervised home use to manage exercise-induced incontinence. We recommend a follow-up visit 1 to 2 weeks after initial training. In this study, we conducted monthly follow-ups to collect data and assess adverse effects; however, in practice, we see women annually.
While pad testing is an accepted method for providing objective data for measuring urine loss (5,6,8,9), a better indicator of treatment success is whether women choose to continue to use the device. Five of 6 participants made the choice to continue using the insert. Cost may preclude some women from choosing this treatment. The price of $49.95 for a box of 28 or $1.78 per device (personal communication, Rochester Medical Corporation, December 2001) must be weighed against the average cost of $0.70 for the alternative of bladder pads for exercise. Medicare and some insurance companies do reimburse patients for the device, so that user cost may be lowered to approximately $0.36 per insert.
A Promising Development
This pilot study shows that the FemSoft urethral device enabled women to resume or increase exercise. Further study will assess the role of the device in promoting exercise in larger numbers of incontinent women over longer periods.
Funding for this study was provided by Rochester Medical Corporation. The authors had complete control and responsibility for conducting the study and analyzing the data.
Dr Dunn is a senior resident physician, Ms Brandt is a registered nurse, and Dr Nygaard is an associate professor, all in the department of obstetrics and gynecology at the University of Iowa College of Medicine in Iowa City. Address correspondence to Ingrid Nygaard, MD, 200 Hawkins Dr, 2 BT GH, Iowa City, IA 52242.