Obstetrics & Gynecology:
Lower Urinary Tract Symptoms and Pelvic Floor Muscle Exercise Adherence After 15 Years
Bø, Kari PhD, PT*; Kvarstein, Bernt MD, PhD†; Nygaard, Ingrid MD, MS‡
From the *Norwegian University of Sport and Physical Education, Department of Sport Medicine, Oslo, Norway; †Akershus University Hospital, Department of Urology, Nordbyhagen, Norway; and ‡Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, Iowa.
Reprints are not available. Address correspondence to: Kari Bø, PhD, Professor, Norwegian University of Sport and Physical Education. P.O. Box 4014, Ullevål Stadion, 0806 Oslo, Norway; e-mail: email@example.com.
Received November 3, 2004. Received in revised form January 3, 2005. Accepted January 5, 2005.
OBJECTIVE: Pelvic floor muscle training effectively treats female stress urinary incontinence. However, data on long-term efficacy and adherence are sparse. Our aims were to assess current lower urinary tract symptoms and exercise adherence 15 years after ending organized training.
METHODS: Originally, 52 women with urodynamic stress urinary incontinence were randomly assigned to home or intensive exercise. After 6 months, 60% in the intensive group were almost or completely continent, compared with 17% in the home group. Fifteen years later, all original study subjects were invited to complete a postal questionnaire assessing urinary symptoms (using validated outcome tools) and current pelvic floor muscle training.
RESULTS: Response rate was 90.4%. There were no differences in any urinary outcomes or satisfaction between the 2 study groups as a whole or when restricted to those without intervening stress urinary incontinence surgery. One half of both groups had stress urinary incontinence surgery during the 15-year follow-up period. Twenty-eight percent performed pelvic floor muscle training at least weekly; this rate did not differ by original group assignment or operated status. More operated women reported severe incontinence (P = .03) and leakage that interfered with daily life (P = .04) than did nonoperated women. There were no other differences between operated and nonoperated women.
CONCLUSION: The marked benefit of intensive pelvic floor muscle training seen short-term was not maintained 15 years later. Long-term adherence to training is low. Urinary symptoms were equally common in both operated and nonoperated women. Further studies are needed to understand factors associated with long-term effectiveness of stress urinary incontinence treatments.
LEVEL OF EVIDENCE: I
The most common type of urinary incontinence in women is stress urinary incontinence,1 defined as “the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing.”2 Consensus groups recommend conservative treatment, and especially pelvic floor muscle training, to be the first-line treatment.3–5 Several randomized controlled trials have demonstrated pelvic floor muscle training to be more effective than no treatment, with short-term cure rates varying between 44% and 70% (Wong K, Fung B, Fung, LCW, Ma S. Pelvic floor exercises in the treatment of stress urinary incontinence in Hong Kong chinese women. Presented at the 27th annual Meeting of the International Continence Society, Yokohama, Japan, 1997).6–9 Pelvic floor muscle training has no adverse effects, and unlike surgery, the success rate of future therapy is not adversely affected by failed treatment.10
However, one criticism of pelvic floor muscle training to treat stress urinary incontinence is the assumed life-long need for regular training. Although extended comparison studies between pelvic floor muscle training and surgery are lacking, surgery is often considered to be more effective over the long term in reducing stress urinary incontinence. Few studies summarize long-term efficacy of either treatment. In a Cochrane review, Hay-Smith et al5 concluded that long-term studies of pelvic floor muscle training are difficult to interpret. Some studies followed up on only one of the comparison groups, while others reported results of the whole cohort rather than by group allocation, or had difficulty tracing an adequate proportion of the original sample. Black and Downs11 and Smith et al12 reported that long-term results of surgery tend to decrease with time. However, most reports of both treatment types include only relatively short follow up, thereby possibly overestimating the success rates.
In 1990 we reported short-term results of 2 different pelvic floor muscle training programs to treat stress urinary incontinence.13 Short-term results after 6 months showed significant improvement and cure rates in favor of intensive exercise compared with home exercise in pelvic floor muscle strength and urinary leakage.13 All women were encouraged to continue to exercise the pelvic floor muscles after ending the trial. However, except at the time of a 5-year follow-up study,14 we did not contact participants or remind them to exercise during the follow-up period.
The aims of the present study were to evaluate current lower urinary tract symptoms, severity of urinary incontinence, incontinence-specific quality of life, and adherence to pelvic floor muscle training in women that participated in a randomized trial 15 years ago, and to compare current lower urinary tract symptoms, quality of life and severity of urinary incontinence in those who later had surgery to those that did not.
MATERIALS AND METHODS
Fifteen years after completing the randomized trial, participants were contacted and invited to complete a postal questionnaire containing demographic characteristics, general health status, interval surgical history, lower urinary tract symptoms, severity of symptoms, quality of life, satisfaction, and current status of pelvic floor muscle training.
Current status and severity of lower urinary tract symptoms and quality of life were assessed by the severity index15 and the International Consultation of Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF).16 Questions about frequency and amount of leakage were from the Severity index.15,17 The question about frequency was “How often do you experience urinary leakage?” with possible answers of 0 = never, 1 = less than once a month, 2 = a few times a month, 3 = a few times a week, and 4 = every day/night. The question about amount of leakage was “How much urine do you lose each time?” with possible answers of 0 = no leakage, 1 = drops, 2 = small splashes, 3 = more.15 By multiplication of frequency and amount of leakage a 5-level severity index from 1–12 was formed (0 = dry, 1–2 = slight, 3–6 = moderate, 8–9 = severe, 12 = very severe).15 The severity index has been compared with 48-hour pad testing and urodynamic testing and has been found to be reproducible and valid in the Norwegian population.15,17,18
Type of incontinence was registered by the self-diagnostic question from the ICIQ-UI SF.19 Quality of life, defined as “how much leaking urine interferes with everyday life,” was measured with a 10-point scale (0 = not at all, 10 = a great deal) from the ICIQ-UI SF. Item score 0 or 1 were chosen to represent no significant bother. The ICIQ-UI SF has been tested for reproducibility, internal consistency, responsiveness, and validity, and is recommended for use in both clinical and epidemiological studies, particularly when more than one measure is being used.16
The questionnaire also contained the Leakage index, a 13-item instrument used in the original study 15 years ago that measures reported leakage on a 5-point scale (1 = never, 5 = always) during a series of provocative physical activities.13,20 An overall mean score is generated. The instrument has been found to be reliable20 and sensitive to change.6,13 After questionnaires were returned, all women were telephoned by a research assistant to fill in missing data. The research assistant was not involved in the training or testing 15 years ago. The study was approved by the Regional Ethics Committee, and all women gave written consent to participate.
Because this was a follow-up study of a defined patient population, we did not conduct an a priori sample size calculation. Three statistical analyses were planned and conducted: 1) Intention-to-treat analysis (including all responding women from the originally randomized groups), 2) Analysis including only nonoperated women from the 2 randomized groups, and 3) Comparison between women who had interval surgery and those who did not. SPSS 11 (SPSS Inc., Chicago, IL) was used for statistical analysis. Results are presented as frequencies and percentages. Comparisons between groups were performed with χ2 and Fisher 2-tailed exact test. Results of the Leakage index are presented as median with range, and the Mann–Whitney U test for nonparametric data was used to compare groups. Odds ratio was estimated by Mantel-Haenszel common odds ratio. The Mantel-Haenszel procedure tests the hypothesis of a common odds ration across strata.21 Correlation between the severity index and the ICIQ-UI SF quality-of-life scale was calculated using the Spearman ρ. A significance level of 0.05 or less was chosen.
Response rate was 91.3% (21 of 23) and 89.7% (26 of 29) in the intensive exercise and home exercise groups, respectively. Table 1 shows current demographic characteristics of the women. There were no significant differences in any background variables. The intention-to-treat analysis comparing women in the original group assignments showed no difference in severity index, incontinence-related quality of life, or monthly or weekly stress urinary incontinence, leakage index, pad use, voiding dysfunction, or urge incontinence between the intensive and home exercise groups (Table 2). Roughly one half of both treatment groups underwent surgery for stress urinary incontinence at some point during the 15-year follow-up period (Table 2). Nine of the 13 operated women in the home exercise group had their surgery within 5 years of cessation of training, whereas 3 of the 11 had surgery within the first 5 years in the intensive exercise group (P = .05). Two women had 2 surgeries and 1 had 3 surgeries.
There were no differences in any outcome measure between nonoperated women originally assigned to either the intensive or home exercise intervention groups. Of the 10 nonoperated women in the intensive exercise group, 5 and 8 reported urinary leakage during the last month during physical activity and coughing and sneezing, respectively, compared with 4 and 7, respectively, of the 13 nonoperated women in the home exercise group. There was also no difference in satisfaction between nonoperated groups (80% in the intensive exercise compared with 76.9% in the home exercise group reported being satisfied or almost satisfied).
Table 3 summarizes differences between those who had interval surgery for stress urinary incontinence and those not operated. Operated women were more likely than nonoperated women to report severe leakage as well as urinary incontinence that interfered with everyday life. Leakage severity correlated significantly with how much urinary leakage interfered with everyday life (ρ = 0.59, P < .01). There were no differences between those operated or not operated in terms of pad use, stress urinary incontinence symptoms in the last month, urge incontinence, or problems with bladder emptying. The majority of women in both groups were satisfied with their present condition. Of those who were satisfied after completing pelvic floor muscle training 15 years ago, 39.4% had surgery by the time of our follow-up. Of those not satisfied 15 years ago, 78.6% had had surgery (Mantel-Haenszel common odds ratio = 0.117, 95% confidence interval 0.041–0.760, P = .02).
Table 4 shows the number of women exercising and not exercising the pelvic floor muscles at present. Twenty-eight percent were exercising at least weekly, 36% periodically, and 36% never exercised the pelvic floor muscles. Of those who exercised, the mean (standard deviation) number of pelvic floor muscle contractions per set was 12 (9.7), and the mean (standard deviation) reported holding time was 9 (6.6) seconds.
Table 5 shows the proportion of women who reported currently performing precontractions of the pelvic floor muscles before coughing, sneezing, and different exercises. One fourth of the women contracted before and during coughing and sneezing.
The marked benefit of intensive pelvic floor muscle training seen short-term was not maintained 15 years later. Urinary symptoms and severity were similar regardless of group assignment, whether or not operated women were included in the analysis. Pelvic floor muscle training adherence also did not differ between the 2 programs and 15 years later; only roughly one quarter of women exercised regularly. Fifty percent in each group had interval stress urinary incontinence surgery. At the time of our questionnaire, operated and nonoperated women reported no difference in most urinary symptoms, satisfaction, or training adherence. However, more operated women reported severe incontinence and leakage that interfered with daily life than did nonoperated women.
Strengths of our study include the high response rates for both treatment groups, the long follow-up period, the use of validated instruments appropriate for questionnaire studies, high data quality, and outcome collection by a nonbiased research assistant. The main limitations include the small sample size and lack of clinical data.
Studies of pelvic floor muscle training with more than 5 years follow-up that include clinical or urodynamic assessment are limited by reporting results for either 1 group only or for a smaller proportion of subjects.14,22–24 This may reflect difficulties in tracing women after several years or motivating participants to undergo urodynamic assessment. Our high follow-up rate is likely partly due to the questionnaire nature of our study design. Although subjects did not undergo urodynamics or other objective tests, we chose questionnaire instruments with excellent test characteristics when compared with urodynamics or pad testing.15,16,18 Our original study was powered to find significant differences between groups with 30 patients and did show significant differences in all parameters comparing 23 and 29 patients.13 However, 15 years later, half of the women in each of the original groups had stress urinary incontinence surgery, creating small sample sizes for comparisons between the nonoperated women in the intensive and home exercise groups. Hence, the nonsignificant differences found in analysis of the nonoperated women may be due to small sample sizes. Similarly, although statistically significant, small group sizes in the subgroups of the severity index call for caution in interpreting the results.
In our population, at variable years removed from surgery, the group of women that underwent surgery did not have fewer urinary symptoms than the group that did not. It is likely that in the short-term after surgery, operated women were more continent than those not operated, but our study design does not allow us to do survival analysis of outcomes. Further, this study was not a randomized trial comparing the outcomes of pelvic floor muscle training and surgery, and those who chose surgery may have had more severe incontinence to begin with. Indeed, women that “fail” pelvic floor muscle training are likely different from those who respond well to physical therapy and may represent a group at high risk of failure no matter what treatment they undergo. Surgeons may be perplexed by the apparent low success rate of surgery in our group. It is of interest to note that long-term follow-up studies of incontinence surgeries show quite different results when surgeons’ own patients are followed up compared to results when a community sample is queried. For example, Diokno et al25 recently reported in a cross-sectional questionnaire study that of 967 women who had a history of continence surgery, 73% reported leakage in the preceding month and 53% wore pads. Satisfaction was not well correlated with leakage. Our results are in line with these. Consistent with our initial study, other short-term studies found that intensive pelvic floor muscle training with close follow-up is more effective than home training or exercise with less follow-up.26–28 This corresponds with results from general strength training studies showing a dose–response relationship in effect.29 After the training period the women in our study were left alone to continue exercising on their own. Although some researchers have found that women find it difficult to adhere to pelvic floor muscle training,30 we followed up our intensive exercise group 5 years after the intervention and found that 70% were still exercising regularly.14 We expected that because these women were improved of stress urinary incontinence, motivated, and independently exercising 5 years after the trial, they would continue to exercise. However, 15 years is a long time, and illnesses and other physical, psychological, and social changes may have made regular exercises harder to do. Studies from exercise science have shown that a 5–10% reduction in muscle strength per week can be expected after strength training is discontinued.31 Even training 1–2 times per week at high intensity is often enough to maintain muscle strength.29,31,32 However, in the present study only 28% were exercising at a frequency required to maintain muscle strength.33
We asked subjects about whether they precontracted the pelvic floor muscles because of evidence suggesting that this “bracing” is another mechanism, in addition to strengthening, by which pelvic muscle training improves leakage. In the original study protocol, we did not specifically instruct women to precontract.13 One fourth of our subjects precontracted the pelvic floor muscles before and during coughing and sneezing, and some believed this to be the main or partial mechanism for their improvement or cure. Adding conscious precontractions to both short- and long-term protocols for pelvic floor muscle training may enhance the effect of this treatment34 and should be studied further. Not surprisingly, women who were originally continent or almost continent after pelvic floor muscle training were less likely to have undergone surgery during the follow-up period than those still wet. Similarly, Cammu et al35 reported that 16 of 24 successful patients after physiotherapy remained satisfied after 10 years, and only 8% had undergone surgery compared with 62% of women that did not initially respond to pelvic floor muscle training.
Thus, responders to pelvic floor muscle training can be sorted out relatively quickly, leaving surgery for those that do not respond to muscle training. For pelvic floor muscle training responders, an important issue is how to organize and finance long-term training. Women in the present study had participated in a program combining individual instruction and monthly assessment with weekly group training and home training.6,13 Group training is a time saving and cost-beneficial way to organize pelvic floor muscle training. Women who have been treated successfully may benefit from the opportunity to continue with group training to maintain muscle function. Another way to organize maintenance training is to incorporate pelvic floor muscle training into general fitness programs for women. Strength training of the pelvic floor muscles should be considered as important as training of abdominal, back, leg, and arm muscles. Because more than 30% of incontinent women are not able to contract the pelvic floor muscles correctly initially,5 proper individual instruction with feedback is essential before embarking on group sessions.
Further work is needed to better understand factors associated with long-term effectiveness of both pelvic floor muscle training and surgery for stress urinary incontinence. Given the high prevalence of stress urinary incontinence and high social burden, it is vital to develop and test intervention models that aim to increase long-term adherence to pelvic floor muscle training.
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