ORIGINAL ARTICLE
Quality of Life in Women Who Use Pessaries for Longer Than 12 Months Sandi Tenfelde, PhD, RN, APN,* Dina Tell, PhD,* Tonya Nicole Thomas, MD,† and Kimberly Kenton, MD, MS‡ Objectives: Pessaries are an effective treatment for pelvic organ prolapse and urinary incontinence; however, few data exist describing long-term pessary use. Our aim was to describe symptom bother and quality of life (QoL) in women using pessaries for urinary incontinence and/or prolapse for at least 12 months. Methods: Consecutive women who met inclusion criteria were approached for this observational cross-sectional study. Wilson and Cleary's HealthRelated Quality of Life Model guided the inclusion of biologic, functional, and individual factors that impact the health-related QoL. Consenting participants completed a generalized QoL index, the Center for Epidemiologic Depression Symptoms, Medical Outcomes Study Social Support Survey, and condition-specific measures; the Pelvic Floor Distress Inventory (PFDI20-SF) and the Pelvic Floor Impact Questionnaire. Results: Fifty-six women, mean age 74.4 years (range, 47–89 years), completed the survey. Mean length of time for pessary use was 4.5 years (1–15 years). Most of the women (n = 31, 55.4%) returned to the clinic for pessary care every 3 months. There was no difference in generalized QoL nor condition-specific total PFDI-20 in women performing self-care versus routine follow-up. Almost one third (29%) of participants reported complications related to pessary use (eg, vaginal erosion), and 41%were considering surgical repair in the near future. Women who were considering surgery had higher PFDI-20 scores relating to more bothersome prolapse symptoms than those not considering surgery (Pelvic Organ Prolapse Distress Inventory 6, 33.91 vs 24.73, P = 0.03). Conclusions: Pessaries can be used to control pelvic floor symptoms for extended periods. Complication rates in this study were lower than previously reported, even in women not doing self-care. Not surprisingly, women considering surgical intervention reported greater symptom bother despite pessary use. Key Words: pessary, quality of life (Female Pelvic Med Reconstr Surg 2015;21: 146–149)
A
pproximately a third of premenopausal women and up to 45% of postmenopausal women will experience pelvic organ prolapse (POP) and/or urinary incontinence (UI)1,2 with estimates increasing as the US population continues to age.2 Although surgery is effective and many women elect to have surgical repair for UI and/or POP, some women may be poor surgical candidates, whereas others prefer nonsurgical treatment options. Nonsurgical treatment options include behavioral therapy with pelvic floor From the *Loyola University Chicago, Marcella Niehoff School of Nursing; †Department of Obstetrics and Gynecology, Loyola University Chicago, Stritch School of Medicine, Maywood; and ‡Department of Obstetrics and Gynecology and Urology, Northwestern University Feinberg School of Medicine, Chicago, IL. Reprints: Sandi Tenfelde, PhD, RN, APN, Loyola University Chicago, Marcella Niehoff School of Nursing, 2160 South First Ave, 105-2840, Maywood, IL 60153. E-mail: [email protected]. The authors have declared they have no conflicts of interest. Supported by Loyola University Chicago School of Nursing Research Stimulation Fund through the Palmer Foundation and research assistance from Sarah DePassa and Jacqueline Garreau. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000154
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muscle training and pessaries. A pessary is a nonsurgical device that when inserted into the vagina can significantly improve symptoms of POP/UI in some women.3–5 Women who use pessaries for 3 to 12 months report high satisfaction rates and significant improvements in quality of life (QoL).6–9 However, most of pessary outcomes research focuses on short-term pessary use with limited data on longer term satisfaction or treatment continuation rates. Women are most likely to discontinue pessary use within the first few months of treatment.10,11 A retrospective chart review of pessary users found that most women (56%) had complications from their pessary that lead to high discontinuation rates.12 Vaginal bleeding, extrusion, severe discomfort, and worsening UI symptoms were complications reported that led to pessary discontinuation. Additional retrospective data noted that women who used a pessary for more than 1 year were more likely to be older at the age of first insertion, whereas prior hysterectomy, POP surgery, and stress incontinence were associated with pessary discontinuation.13 No current studies prospectively examine biologic, functional, and individual factors that impact the health-related QoL in women for whom this nonsurgical treatment for POP is successful. The aim of this study was to examine QoL for women with long-term (greater than 12 months) use of a vaginal pessary for the treatment of POP/UI.
MATERIALS AND METHODS This study was funded by the Palmer Foundation and approved by the Institutional Review Board at Loyola University. Adult women presenting to the Female Pelvic Medicine and Reconstructive Surgery clinic at a tertiary care academic medical center, who had used a pessary for at least 12 months and were able to read English were invited to participate. Consenting participants completed a series of condition-specific and general healthrelated concerns and QoL questionnaires. The questionnaires took approximately 45 to 60 minutes to complete, and participants were compensated $25 for study participation. Participants either completed the questionnaires during their clinic visit or at home and returned them in a stamped envelope via postal mail. Selected components from the Wilson and Cleary's HealthRelated Quality of Life Model14,15 were used to guide the study. This model suggests that the characteristics of the individual as well as the characteristics of the environment can have an impact on health-related outcomes. The model has been used extensively in clinical research16 as it lends itself to the assessment of 5 major patient factors related to health-related outcomes: (1) biological, (2) functional status, (3) symptoms, (4) general health perceptions, and (5) QoL. Our intent was not to test the model; rather it was used as a heuristic framework to guide the selection of variables for analysis. Biologic and individual factors related to pessary use including age, race/ethnicity, marital status, length of time for using a pessary, use of pessary for either UI or prolapse or both, stage of pelvic floor support were obtained from the medical record. Participants also completed a comorbidities index to assess additional health-related concerns that may not have been captured in the
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
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Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
QoL of Long-term Pessary Users
TABLE 1. Demographic and Clinical Characteristics Sample Characteristics Age, mean (SD), y White, % BMI, kg/m2 Married, % Reason for pessary use UI POP Both Years of pessary use, mean (SD) Comorbidities, mean (SD) Complications, n = yes (%) Considering surgery, n = yes (%)
All Women
Self-Care (n = 25)
74.5 (9.0) 88 26.5 37
68.88 (8.61) 88 26.1 75
12 33 11 4.5 (3.6) 2.5 (1.9) 16 (28) 23 (41)
5 17 9 5.3 (4.20) 1.96 (1.79) 9 (36) 13 (52)
clinic record.17 A comorbidity composite score was computed by calculating the sum of the reported health conditions. We grouped participants according to whether they inserted and removed their pessary in between annual clinic visits (selfcare) or if they only returned to the office for pessary care. In our clinic, women who return for office care are scheduled for visits every 3 months. Women in the self-care group were asked to quantify how often they removed and reinserted their pessary. All women were queried regarding complications from the pessary, and if they were considering surgical repair of their pelvic floor in the future. For women who indicated complications for pessary use, they were asked to provide comments in an openended response section. Validated questionnaires were used to assess pelvic floor symptom concerns and health-related QoL, depressive symptoms, and general health perceptions. Participants completed 2 condition-specific health-related QoL measures: the short forms of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire- short form 7 (PFIQ-7).6 The PFDI-20 is a 20-item instrument that addresses specific pelvic floor symptoms and the degree to which they are bothersome to the individual. The PFIQ-7-SF assesses urinary, bowel, and vaginal symptoms in terms of the impact that they have relative to 7 specific daily activities (eg, household chores and travel). Each questionnaire contains subscales for urinary, prolapse, and colorectal anal symptoms. Higher scores indicate more dysfunction. These measures have had psychometric evaluation for validity, reliability, and responsiveness.6,18 Women with chronic conditions often experience depressive symptoms. The Center for Epidemiologic Depression Symptoms (CES-D) measures “depressive symptoms” and their severity (0, none to 3, most of the time). Higher scores indicate more
Significance, P
Office Care (n = 31) 78.94 (6.48) 87 27.0 35
0.001 0.93 0.56 0.01
7 16 2 3.81 (2.85) 2.94 (1.94) 7 (22.6) 10 (32.3)
0.12 0.06 0.27 0.16
depressive symptoms; scores greater than 16 indicate risk for depressive disorder.19 To assess social support, we used the Medical Outcomes Study (MOS) Social Support Survey.20 This is a 19-item tool used to measure 4 specific areas of support (emotional/informational, tangible, positive interaction, and affection). Scores range from a minimum of 19 to a high score of 95, higher scores indicate more social support. Reliability of the overall tool and its subscales is high. Validity by factor analysis as well as significant correlations with health measures have been reported.20 The QoL index was used to assess QoL, particularly life satisfaction.15,21 This tool consists of 34 items that measure satisfaction (1, very dissatisfied to 6, very satisfied) and importance (1, very unimportant to 6, very important) in 4 areas of life (health and functioning, social and economic, psychological/spiritual, and family) that impact QoL for persons. Higher scores indicate higher QoL. Reliability and validity of the QoL index is well established.22 Demographic and clinical characteristics were analyzed using descriptive statistics, with measures of central tendencies and frequencies. The open-ended responses were analyzed as content analysis. Group differences were analyzed using the independent samples t test for continuous data and Mann-Whitney U for nonparametric data. Pearson correlation coefficients were computed to examine bivariate relationships between variables. All statistical analysis was conducted using SPSS, version 20.0 (Chicago, IL).
RESULTS Fifty-six women consented to participate in this descriptive study; participant characteristics can be found in Table 1. In
TABLE 2. Selected Measures Measures, Mean (SD)
All Women
Self-Care (n = 25)
Office Care (n = 31)
Significance, P
Pelvic Floor Distress Inventory Urinary Distress Inventory Colorectal Distress Inventory POP Distress Inventory Pelvic Floor Impact Questionnaire QoL index Center for Epidemiologic Depression Symptoms (CES-D) MOS Social Support Survey
70.5 (58.5) 30.3 (26.9) 22.2 (21.7) 18.1 (19.7) 35.2 (53.9) 24.5 (4.0) 11.0 (7.9) 74.8 (16.5)
64.3 (49.3) 25.7 (23.1) 21.6 (22.7) 17.0 (14.5) 26.5 (37.7) 25.2 (4.4) 10.6 (9.1) 72.9 (15.1)
75.7 (65.5) 34.2 (29.6) 22.6 (21.1) 19.0 (23.3) 42.5 (64.1) 23.8 (3.6) 11.4 (6.9) 77.1 (18.2)
0.46 0.24 0.86 0.72 0.28 0.19 0.73 0.37
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Tenfelde et al
TABLE 3. Sample Open-Ended Responses No complications Complications resolved
“For me it's wonderful! The prolapse I had was miserable, but this has brought me back to a normal life!” “It took a little while at first used to get to it” “On vacation two years ago, I didn't remove my pessary for two weeks. The vagina became very irritated. Estrogen cream repaired any damage.” “At one time I became irritated and my doctor told me to keep it out 3 to 4 weeks until everything was healed. That was approximately 5 years ago.” “I was leaving my pessary inserted more than 2 months, which was not a good thing. Because it cause me to have (an) infection. I got treated with medicine and I was fine. I do not have any complications now.” “I've had some bleeding and now granulated tissue (polyp). However the use of it far outweighs the complications” “I wore the pessary every day, but irritation developed. I found it is only necessary to wear the pessary during strenuous activity, playing tennis 3 times week, gardening, on long walks (2–3 miles). Therefore, I only remove and clean the pessary 3 times a week at minimum. I have worn it most of the day, but that is not the norm for me.”
general, the sample consisted primarily of older (mean age, 75 years; range, 49–85 years), white (84%) women. The average duration of pessary use was 4.5 years (1–15 years). Most of the women used a pessary for POP (n = 30, 51%) or POP and UI symptoms (n = 11, 19%). The remainder used their pessary for UI only. Many women reported additional health issues, the most frequently occurring comorbidities include arthritis (n = 27, 48%), osteoporosis (n = 18, 32%), and gastrointestinal concerns like ulcers and hernias (n = 19, 34%). Less than 10% reported comorbidities like asthma, cardiovascular disease, or stroke. The study population was closely divided between women performing self-care (n = 25, 44%), and those returning to the clinic for their health care provider to remove and reinsert the pessary at regularly scheduled appointments (n = 31, 56%). Women who returned to the office for pessary care were significantly older (79 v. 69 years; t = 4.96, P = 0.001) and had significantly more health problems with an average of 4 comorbid conditions compared to 2 health conditions for women in the self-care group (P = 0.03). Most women who performed self-care removed their pessary daily (n = 20, 40%) or a few times per week (n = 20, 40%), with fewer women removing their pessary monthly or greater (n = 6, 20%). There were no significant differences in pelvic floor symptom concerns and health-related QoL, depressive symptoms, and general health perceptions between women who performed self-care and women who returned to clinic for pessary care. The PFDI-20, PFIQ-7, health-related QOL, CESD, MOS scores are listed in Table 2 for the entire cohort and by care group. Overall, women reported high levels of QOL. Health-related QoL scores correlated negatively with PFDI-20 scores (ρ = −0.55, P = 0.001). Women with higher QoL reported fewer pelvic floor symptoms for each of the subscales (urinary, colorectal, and prolapse). Findings from the MOS Social Support Survey indicate that women reported a range of social support (range, 32–95; mean [SD], 74.8 [16.5]). Although there were no significant differences between women who performed self-care and women who returned to office care, women who reported considering surgery reported significantly lower levels of social support (t[54] = 2.61, P = 0.01). Seventy-five percent of the women (n = 55) had CES-D scores of less than 16, which is the cutoff for risk for depression. Women with the highest scores on the CES-D reported a history of depression on the comorbidity index. There were no differences in CES-D scores between pessary care groups or women considering surgery. The CES-D scores correlated with overall QOL as well as pelvic floor symptoms as measured by the PFDI-20. Women with low levels of depressive symptoms reported higher levels of QOL (r = −0.52, P < 0.001) and fewer pelvic floor distress symptoms (r = 0.47, P < 0.001).20
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Most of the women did not report any complications from their pessary (n = 39, 71%). Seventeen (29%) women reported complications from pessary use. There was no association between frequency of pessary change and complications (χ2 [3, n = 56] = 2.9, P = 0.39). In the open-ended response section, the most commonly reported complication was vaginal irritation and/or bleeding (n = 14, 25%). Several women who reported complications provided additional information, noting that these complications resolved with removal of the pessary and the use of vaginal estrogen. Many women commented on their long-term use of pessaries in the open-ended responses. Sample responses are included in Table 3. Almost half (n = 25, 42%) were considering a surgical repair of their pelvic floor dysfunction in the future. Six women reported a plan to have a surgical repair within the next 12 months, whereas the remainder of the women selected “considering surgery in the future.” Women considering surgery did not differ by age, whether the pessary was used for incontinence or prolapse, how long the pessary was used, whether they cared for the pessary at home, or returned for office care. Women who reported complications from their pessary were more likely to be considering surgery (P = 0.04) than women without complications. Although total PFDI-20 scores were not statistically different between women who were considering surgery and those who were not; women who were considering surgery reported more bother in the POP subscale (POPDI) than those not considering surgery (33.9 vs 24.7, P = 0.03). Women with lower social support were more likely to consider surgery (P = 0.01) than women who reported more social support.
DISCUSSION Pessaries are considered a first-line treatment for women with POP/UI; however, there are no clear guidelines on frequency of follow-up or management of complications. Our results suggest that either of 2 common treatment options—self-care or regular pessary office follow-up every 3 months—result in significant improvement in pelvic floor symptoms and health-related QOL with few complications. These findings are important for older women and women who have comorbidities, who may be unable to change the pessary independently. Although other studies have reported a high complication rate which often resulted in discontinuation of pessary use,12,23 only a small subset of women in this sample reported complications from their pessary use. However, consistent with these studies, the women who reported complications were more likely to consider surgery. The women in our study have used a pessary for longer than 12 months, and likely excluded women who discontinued pessary use from early complications. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
An important strength in our study is the inclusion of the Health-Related Quality of Life Model, which encouraged the inclusion of health-related QoL, depressive symptoms, and general health perceptions in addition to pelvic floor symptom concerns. Although pelvic floor symptoms may cause women to seek care, additional factors such as mental health and social support measures are important for clinicians to consider when addressing the care needs of their pelvic floor patients. Although depressive symptoms in our study were low, women with pelvic floor symptoms reported more depressive symptoms. Mental health concerns need to be assessed clinically, and appropriate referrals made as necessary to help women deal with chronic health issues. Additionally, women with low social support were more likely to consider surgery, as it may be challenging to coordinate travel to and from the office for pessary care. Perhaps, clinicians should screen for social support and discuss this as part of shared decision making when counseling patients about treatment options. Our study had several limitations. This is a small convenience sample of women who were willing to participate. We did not complete a power analysis. Although we evaluated differences between self-care and provider directed care, the study was not powered to adequately detect statistical differences. In addition to the small sample size, women in this study were able to select to participate. This may have biased our sample. Additionally, women who continue to use the pessary beyond the 1-year period have proven successful with pessary use and are likely different from women who discontinue use within the first year. This is a relatively healthy sample of women and few women had multiple comorbidities. Our comorbidity index was not a validated measure. It is possible that the women who elected not to participate had greater complications with pessary use and poorer outcomes. Baseline information before pessary use on QoL measures were not available for this sample, making inference on how the pessary impacted QoL beyond the scope of this study. Our results are generalizable to older, white women with UI and/or POP who selected longterm pessary management for their PFD. The findings from this study may not be generalizable beyond this population. In general, long-term pessary users are happy with pessaries and symptoms control; not surprisingly, women with more pelvic floor symptoms are more likely to consider surgery. REFERENCES 1. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311–1316. 2. Wu JM, Hundley AF, Fulton RG, et al. Forecasting the prevalence of pelvic floor disorders in U.S. women: 2010 to 2050. Obstet Gynecol. 2009; 114(6):1278–1283. 3. Richter HE, Burgio KL, Brubaker L, et al. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010;115(3):609–617. 4. Kenton K, Barber M, Wang L, et al. Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence. Female Pelvic Med Reconstr Surg. 2012;18(2):118–121.
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QoL of Long-term Pessary Users
5. Cundiff GW, Amundsen CL, Bent AE, et al. The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol. 2007;196(4):405–407. 6. Barber MD, Walters MD, Cundiff GW. Responsiveness of the pelvic floor distress inventory (PFDI-20) and pelvic floor impact questionnaire (PFIQ-7) in women undergoing vaginal surgery and pessary treatment for pelvic organ prolapse. Am J Obstet Gynecol. 2006;194(5):1492–1498. 7. Jones K, Yang L, Lowder JL, et al. Effect of pessary use on genital hiatus measurements in women with pelvic organ prolapse. Obstet Gynecol. 2008;112(3):630–636. 8. Komesu YM, Rogers RG, Rode MA, et al. Patient-selected goal attainment for pessary wearers: what is the clinical relevance? Am J Obstet Gynecol. 2008;198(5):577.e1–577.e5. 9. Komesu YM, Rogers RG, Rode MA, et al. Pelvic floor symptom changes in pessary users. Am J Obstet Gynecol. 2007;197(6):620. e1–620.e6. 10. Lone F, Thakar R, Sultan AH, et al. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011; 114(1):56–59. 11. Nemeth Z, Nagy S, Ott J. The cube pessary: an underestimated treatment option for pelvic organ prolapse? Subjective 1-year outcomes. Int Urogynecol J. 2013;24(10):1695–1701. 12. Sarma S, Ying T, Moore KH. Long-term vaginal ring pessary use: discontinuation rates and adverse events. BJOG. 2009;116(13):1715–1721. 13. Friedman S, Sandhu KS, Wang C, et al. Factors influencing long-term pessary use. Int Urogynecol J. 2010;21(6):673–678. 14. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995; 273(1):59–65. 15. Ferrans CE, Zerwic JJ, Wilbur JE, et al. Conceptual model of health-related quality of life. J Nurs Scholarsh. 2005;37(4):336–342. 16. Bakas T, McLennon SM, Carpenter JS, et al. Systematic review of health-related quality of life models. Health Qual Life Outcomes. 2012;10:134. 17. Groll DL, To T, Bombardier C, et al. The development of a comorbidity index with physical function as the outcome. J Clin Epidemiol. 2005; 58(6):595–602. 18. Wren PA, Janz NK, Brubaker L, et al. Reliability of health-related quality-of-life measures 1 year after surgical procedures for pelvic floor disorders. Am J Obstet Gynecol. 2005;192(3):780–788. 19. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1:385–401. 20. Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705–714. 21. Rannestad T, Skjeldestad FE. Ferrans and Powers' quality of life index applied in urinary incontinence research—a pilot study. Scand J Caring Sci. 2011;25(2):410–416. 22. Ferrans CE, Powers MJ. Psychometric assessment of the quality of life index. Res Nurs Health. 1992;15(1):29–38. 23. Alperin M, Khan A, Dubina E, et al. Patterns of pessary care and outcomes for medicare beneficiaries with pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2013;19(3):142–147.
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Quality of Life in Women Who Use Pessaries for Longer Than 12 Months Sandi Tenfelde, PhD, RN, APN,* Dina Tell, PhD,* Tonya Nicole Thomas, MD,† and Kimberly Kenton, MD, MS‡ Objectives: Pessaries are an effective treatment for pelvic organ prolapse and urinary incontinence; however, few data exist describing long-term pessary use. Our aim was to describe symptom bother and quality of life (QoL) in women using pessaries for urinary incontinence and/or prolapse for at least 12 months. Methods: Consecutive women who met inclusion criteria were approached for this observational cross-sectional study. Wilson and Cleary's HealthRelated Quality of Life Model guided the inclusion of biologic, functional, and individual factors that impact the health-related QoL. Consenting participants completed a generalized QoL index, the Center for Epidemiologic Depression Symptoms, Medical Outcomes Study Social Support Survey, and condition-specific measures; the Pelvic Floor Distress Inventory (PFDI20-SF) and the Pelvic Floor Impact Questionnaire. Results: Fifty-six women, mean age 74.4 years (range, 47–89 years), completed the survey. Mean length of time for pessary use was 4.5 years (1–15 years). Most of the women (n = 31, 55.4%) returned to the clinic for pessary care every 3 months. There was no difference in generalized QoL nor condition-specific total PFDI-20 in women performing self-care versus routine follow-up. Almost one third (29%) of participants reported complications related to pessary use (eg, vaginal erosion), and 41%were considering surgical repair in the near future. Women who were considering surgery had higher PFDI-20 scores relating to more bothersome prolapse symptoms than those not considering surgery (Pelvic Organ Prolapse Distress Inventory 6, 33.91 vs 24.73, P = 0.03). Conclusions: Pessaries can be used to control pelvic floor symptoms for extended periods. Complication rates in this study were lower than previously reported, even in women not doing self-care. Not surprisingly, women considering surgical intervention reported greater symptom bother despite pessary use. Key Words: pessary, quality of life (Female Pelvic Med Reconstr Surg 2015;21: 146–149)
A
pproximately a third of premenopausal women and up to 45% of postmenopausal women will experience pelvic organ prolapse (POP) and/or urinary incontinence (UI)1,2 with estimates increasing as the US population continues to age.2 Although surgery is effective and many women elect to have surgical repair for UI and/or POP, some women may be poor surgical candidates, whereas others prefer nonsurgical treatment options. Nonsurgical treatment options include behavioral therapy with pelvic floor From the *Loyola University Chicago, Marcella Niehoff School of Nursing; †Department of Obstetrics and Gynecology, Loyola University Chicago, Stritch School of Medicine, Maywood; and ‡Department of Obstetrics and Gynecology and Urology, Northwestern University Feinberg School of Medicine, Chicago, IL. Reprints: Sandi Tenfelde, PhD, RN, APN, Loyola University Chicago, Marcella Niehoff School of Nursing, 2160 South First Ave, 105-2840, Maywood, IL 60153. E-mail: [email protected]. The authors have declared they have no conflicts of interest. Supported by Loyola University Chicago School of Nursing Research Stimulation Fund through the Palmer Foundation and research assistance from Sarah DePassa and Jacqueline Garreau. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/SPV.0000000000000154
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muscle training and pessaries. A pessary is a nonsurgical device that when inserted into the vagina can significantly improve symptoms of POP/UI in some women.3–5 Women who use pessaries for 3 to 12 months report high satisfaction rates and significant improvements in quality of life (QoL).6–9 However, most of pessary outcomes research focuses on short-term pessary use with limited data on longer term satisfaction or treatment continuation rates. Women are most likely to discontinue pessary use within the first few months of treatment.10,11 A retrospective chart review of pessary users found that most women (56%) had complications from their pessary that lead to high discontinuation rates.12 Vaginal bleeding, extrusion, severe discomfort, and worsening UI symptoms were complications reported that led to pessary discontinuation. Additional retrospective data noted that women who used a pessary for more than 1 year were more likely to be older at the age of first insertion, whereas prior hysterectomy, POP surgery, and stress incontinence were associated with pessary discontinuation.13 No current studies prospectively examine biologic, functional, and individual factors that impact the health-related QoL in women for whom this nonsurgical treatment for POP is successful. The aim of this study was to examine QoL for women with long-term (greater than 12 months) use of a vaginal pessary for the treatment of POP/UI.
MATERIALS AND METHODS This study was funded by the Palmer Foundation and approved by the Institutional Review Board at Loyola University. Adult women presenting to the Female Pelvic Medicine and Reconstructive Surgery clinic at a tertiary care academic medical center, who had used a pessary for at least 12 months and were able to read English were invited to participate. Consenting participants completed a series of condition-specific and general healthrelated concerns and QoL questionnaires. The questionnaires took approximately 45 to 60 minutes to complete, and participants were compensated $25 for study participation. Participants either completed the questionnaires during their clinic visit or at home and returned them in a stamped envelope via postal mail. Selected components from the Wilson and Cleary's HealthRelated Quality of Life Model14,15 were used to guide the study. This model suggests that the characteristics of the individual as well as the characteristics of the environment can have an impact on health-related outcomes. The model has been used extensively in clinical research16 as it lends itself to the assessment of 5 major patient factors related to health-related outcomes: (1) biological, (2) functional status, (3) symptoms, (4) general health perceptions, and (5) QoL. Our intent was not to test the model; rather it was used as a heuristic framework to guide the selection of variables for analysis. Biologic and individual factors related to pessary use including age, race/ethnicity, marital status, length of time for using a pessary, use of pessary for either UI or prolapse or both, stage of pelvic floor support were obtained from the medical record. Participants also completed a comorbidities index to assess additional health-related concerns that may not have been captured in the
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
Copyright © 2015 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
QoL of Long-term Pessary Users
TABLE 1. Demographic and Clinical Characteristics Sample Characteristics Age, mean (SD), y White, % BMI, kg/m2 Married, % Reason for pessary use UI POP Both Years of pessary use, mean (SD) Comorbidities, mean (SD) Complications, n = yes (%) Considering surgery, n = yes (%)
All Women
Self-Care (n = 25)
74.5 (9.0) 88 26.5 37
68.88 (8.61) 88 26.1 75
12 33 11 4.5 (3.6) 2.5 (1.9) 16 (28) 23 (41)
5 17 9 5.3 (4.20) 1.96 (1.79) 9 (36) 13 (52)
clinic record.17 A comorbidity composite score was computed by calculating the sum of the reported health conditions. We grouped participants according to whether they inserted and removed their pessary in between annual clinic visits (selfcare) or if they only returned to the office for pessary care. In our clinic, women who return for office care are scheduled for visits every 3 months. Women in the self-care group were asked to quantify how often they removed and reinserted their pessary. All women were queried regarding complications from the pessary, and if they were considering surgical repair of their pelvic floor in the future. For women who indicated complications for pessary use, they were asked to provide comments in an openended response section. Validated questionnaires were used to assess pelvic floor symptom concerns and health-related QoL, depressive symptoms, and general health perceptions. Participants completed 2 condition-specific health-related QoL measures: the short forms of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire- short form 7 (PFIQ-7).6 The PFDI-20 is a 20-item instrument that addresses specific pelvic floor symptoms and the degree to which they are bothersome to the individual. The PFIQ-7-SF assesses urinary, bowel, and vaginal symptoms in terms of the impact that they have relative to 7 specific daily activities (eg, household chores and travel). Each questionnaire contains subscales for urinary, prolapse, and colorectal anal symptoms. Higher scores indicate more dysfunction. These measures have had psychometric evaluation for validity, reliability, and responsiveness.6,18 Women with chronic conditions often experience depressive symptoms. The Center for Epidemiologic Depression Symptoms (CES-D) measures “depressive symptoms” and their severity (0, none to 3, most of the time). Higher scores indicate more
Significance, P
Office Care (n = 31) 78.94 (6.48) 87 27.0 35
0.001 0.93 0.56 0.01
7 16 2 3.81 (2.85) 2.94 (1.94) 7 (22.6) 10 (32.3)
0.12 0.06 0.27 0.16
depressive symptoms; scores greater than 16 indicate risk for depressive disorder.19 To assess social support, we used the Medical Outcomes Study (MOS) Social Support Survey.20 This is a 19-item tool used to measure 4 specific areas of support (emotional/informational, tangible, positive interaction, and affection). Scores range from a minimum of 19 to a high score of 95, higher scores indicate more social support. Reliability of the overall tool and its subscales is high. Validity by factor analysis as well as significant correlations with health measures have been reported.20 The QoL index was used to assess QoL, particularly life satisfaction.15,21 This tool consists of 34 items that measure satisfaction (1, very dissatisfied to 6, very satisfied) and importance (1, very unimportant to 6, very important) in 4 areas of life (health and functioning, social and economic, psychological/spiritual, and family) that impact QoL for persons. Higher scores indicate higher QoL. Reliability and validity of the QoL index is well established.22 Demographic and clinical characteristics were analyzed using descriptive statistics, with measures of central tendencies and frequencies. The open-ended responses were analyzed as content analysis. Group differences were analyzed using the independent samples t test for continuous data and Mann-Whitney U for nonparametric data. Pearson correlation coefficients were computed to examine bivariate relationships between variables. All statistical analysis was conducted using SPSS, version 20.0 (Chicago, IL).
RESULTS Fifty-six women consented to participate in this descriptive study; participant characteristics can be found in Table 1. In
TABLE 2. Selected Measures Measures, Mean (SD)
All Women
Self-Care (n = 25)
Office Care (n = 31)
Significance, P
Pelvic Floor Distress Inventory Urinary Distress Inventory Colorectal Distress Inventory POP Distress Inventory Pelvic Floor Impact Questionnaire QoL index Center for Epidemiologic Depression Symptoms (CES-D) MOS Social Support Survey
70.5 (58.5) 30.3 (26.9) 22.2 (21.7) 18.1 (19.7) 35.2 (53.9) 24.5 (4.0) 11.0 (7.9) 74.8 (16.5)
64.3 (49.3) 25.7 (23.1) 21.6 (22.7) 17.0 (14.5) 26.5 (37.7) 25.2 (4.4) 10.6 (9.1) 72.9 (15.1)
75.7 (65.5) 34.2 (29.6) 22.6 (21.1) 19.0 (23.3) 42.5 (64.1) 23.8 (3.6) 11.4 (6.9) 77.1 (18.2)
0.46 0.24 0.86 0.72 0.28 0.19 0.73 0.37
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Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
Tenfelde et al
TABLE 3. Sample Open-Ended Responses No complications Complications resolved
“For me it's wonderful! The prolapse I had was miserable, but this has brought me back to a normal life!” “It took a little while at first used to get to it” “On vacation two years ago, I didn't remove my pessary for two weeks. The vagina became very irritated. Estrogen cream repaired any damage.” “At one time I became irritated and my doctor told me to keep it out 3 to 4 weeks until everything was healed. That was approximately 5 years ago.” “I was leaving my pessary inserted more than 2 months, which was not a good thing. Because it cause me to have (an) infection. I got treated with medicine and I was fine. I do not have any complications now.” “I've had some bleeding and now granulated tissue (polyp). However the use of it far outweighs the complications” “I wore the pessary every day, but irritation developed. I found it is only necessary to wear the pessary during strenuous activity, playing tennis 3 times week, gardening, on long walks (2–3 miles). Therefore, I only remove and clean the pessary 3 times a week at minimum. I have worn it most of the day, but that is not the norm for me.”
general, the sample consisted primarily of older (mean age, 75 years; range, 49–85 years), white (84%) women. The average duration of pessary use was 4.5 years (1–15 years). Most of the women used a pessary for POP (n = 30, 51%) or POP and UI symptoms (n = 11, 19%). The remainder used their pessary for UI only. Many women reported additional health issues, the most frequently occurring comorbidities include arthritis (n = 27, 48%), osteoporosis (n = 18, 32%), and gastrointestinal concerns like ulcers and hernias (n = 19, 34%). Less than 10% reported comorbidities like asthma, cardiovascular disease, or stroke. The study population was closely divided between women performing self-care (n = 25, 44%), and those returning to the clinic for their health care provider to remove and reinsert the pessary at regularly scheduled appointments (n = 31, 56%). Women who returned to the office for pessary care were significantly older (79 v. 69 years; t = 4.96, P = 0.001) and had significantly more health problems with an average of 4 comorbid conditions compared to 2 health conditions for women in the self-care group (P = 0.03). Most women who performed self-care removed their pessary daily (n = 20, 40%) or a few times per week (n = 20, 40%), with fewer women removing their pessary monthly or greater (n = 6, 20%). There were no significant differences in pelvic floor symptom concerns and health-related QoL, depressive symptoms, and general health perceptions between women who performed self-care and women who returned to clinic for pessary care. The PFDI-20, PFIQ-7, health-related QOL, CESD, MOS scores are listed in Table 2 for the entire cohort and by care group. Overall, women reported high levels of QOL. Health-related QoL scores correlated negatively with PFDI-20 scores (ρ = −0.55, P = 0.001). Women with higher QoL reported fewer pelvic floor symptoms for each of the subscales (urinary, colorectal, and prolapse). Findings from the MOS Social Support Survey indicate that women reported a range of social support (range, 32–95; mean [SD], 74.8 [16.5]). Although there were no significant differences between women who performed self-care and women who returned to office care, women who reported considering surgery reported significantly lower levels of social support (t[54] = 2.61, P = 0.01). Seventy-five percent of the women (n = 55) had CES-D scores of less than 16, which is the cutoff for risk for depression. Women with the highest scores on the CES-D reported a history of depression on the comorbidity index. There were no differences in CES-D scores between pessary care groups or women considering surgery. The CES-D scores correlated with overall QOL as well as pelvic floor symptoms as measured by the PFDI-20. Women with low levels of depressive symptoms reported higher levels of QOL (r = −0.52, P < 0.001) and fewer pelvic floor distress symptoms (r = 0.47, P < 0.001).20
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Most of the women did not report any complications from their pessary (n = 39, 71%). Seventeen (29%) women reported complications from pessary use. There was no association between frequency of pessary change and complications (χ2 [3, n = 56] = 2.9, P = 0.39). In the open-ended response section, the most commonly reported complication was vaginal irritation and/or bleeding (n = 14, 25%). Several women who reported complications provided additional information, noting that these complications resolved with removal of the pessary and the use of vaginal estrogen. Many women commented on their long-term use of pessaries in the open-ended responses. Sample responses are included in Table 3. Almost half (n = 25, 42%) were considering a surgical repair of their pelvic floor dysfunction in the future. Six women reported a plan to have a surgical repair within the next 12 months, whereas the remainder of the women selected “considering surgery in the future.” Women considering surgery did not differ by age, whether the pessary was used for incontinence or prolapse, how long the pessary was used, whether they cared for the pessary at home, or returned for office care. Women who reported complications from their pessary were more likely to be considering surgery (P = 0.04) than women without complications. Although total PFDI-20 scores were not statistically different between women who were considering surgery and those who were not; women who were considering surgery reported more bother in the POP subscale (POPDI) than those not considering surgery (33.9 vs 24.7, P = 0.03). Women with lower social support were more likely to consider surgery (P = 0.01) than women who reported more social support.
DISCUSSION Pessaries are considered a first-line treatment for women with POP/UI; however, there are no clear guidelines on frequency of follow-up or management of complications. Our results suggest that either of 2 common treatment options—self-care or regular pessary office follow-up every 3 months—result in significant improvement in pelvic floor symptoms and health-related QOL with few complications. These findings are important for older women and women who have comorbidities, who may be unable to change the pessary independently. Although other studies have reported a high complication rate which often resulted in discontinuation of pessary use,12,23 only a small subset of women in this sample reported complications from their pessary use. However, consistent with these studies, the women who reported complications were more likely to consider surgery. The women in our study have used a pessary for longer than 12 months, and likely excluded women who discontinued pessary use from early complications. © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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Female Pelvic Medicine & Reconstructive Surgery • Volume 21, Number 3, May/June 2015
An important strength in our study is the inclusion of the Health-Related Quality of Life Model, which encouraged the inclusion of health-related QoL, depressive symptoms, and general health perceptions in addition to pelvic floor symptom concerns. Although pelvic floor symptoms may cause women to seek care, additional factors such as mental health and social support measures are important for clinicians to consider when addressing the care needs of their pelvic floor patients. Although depressive symptoms in our study were low, women with pelvic floor symptoms reported more depressive symptoms. Mental health concerns need to be assessed clinically, and appropriate referrals made as necessary to help women deal with chronic health issues. Additionally, women with low social support were more likely to consider surgery, as it may be challenging to coordinate travel to and from the office for pessary care. Perhaps, clinicians should screen for social support and discuss this as part of shared decision making when counseling patients about treatment options. Our study had several limitations. This is a small convenience sample of women who were willing to participate. We did not complete a power analysis. Although we evaluated differences between self-care and provider directed care, the study was not powered to adequately detect statistical differences. In addition to the small sample size, women in this study were able to select to participate. This may have biased our sample. Additionally, women who continue to use the pessary beyond the 1-year period have proven successful with pessary use and are likely different from women who discontinue use within the first year. This is a relatively healthy sample of women and few women had multiple comorbidities. Our comorbidity index was not a validated measure. It is possible that the women who elected not to participate had greater complications with pessary use and poorer outcomes. Baseline information before pessary use on QoL measures were not available for this sample, making inference on how the pessary impacted QoL beyond the scope of this study. Our results are generalizable to older, white women with UI and/or POP who selected longterm pessary management for their PFD. The findings from this study may not be generalizable beyond this population. In general, long-term pessary users are happy with pessaries and symptoms control; not surprisingly, women with more pelvic floor symptoms are more likely to consider surgery. REFERENCES 1. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311–1316. 2. Wu JM, Hundley AF, Fulton RG, et al. Forecasting the prevalence of pelvic floor disorders in U.S. women: 2010 to 2050. Obstet Gynecol. 2009; 114(6):1278–1283. 3. Richter HE, Burgio KL, Brubaker L, et al. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010;115(3):609–617. 4. Kenton K, Barber M, Wang L, et al. Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence. Female Pelvic Med Reconstr Surg. 2012;18(2):118–121.
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QoL of Long-term Pessary Users
5. Cundiff GW, Amundsen CL, Bent AE, et al. The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol. 2007;196(4):405–407. 6. Barber MD, Walters MD, Cundiff GW. Responsiveness of the pelvic floor distress inventory (PFDI-20) and pelvic floor impact questionnaire (PFIQ-7) in women undergoing vaginal surgery and pessary treatment for pelvic organ prolapse. Am J Obstet Gynecol. 2006;194(5):1492–1498. 7. Jones K, Yang L, Lowder JL, et al. Effect of pessary use on genital hiatus measurements in women with pelvic organ prolapse. Obstet Gynecol. 2008;112(3):630–636. 8. Komesu YM, Rogers RG, Rode MA, et al. Patient-selected goal attainment for pessary wearers: what is the clinical relevance? Am J Obstet Gynecol. 2008;198(5):577.e1–577.e5. 9. Komesu YM, Rogers RG, Rode MA, et al. Pelvic floor symptom changes in pessary users. Am J Obstet Gynecol. 2007;197(6):620. e1–620.e6. 10. Lone F, Thakar R, Sultan AH, et al. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011; 114(1):56–59. 11. Nemeth Z, Nagy S, Ott J. The cube pessary: an underestimated treatment option for pelvic organ prolapse? Subjective 1-year outcomes. Int Urogynecol J. 2013;24(10):1695–1701. 12. Sarma S, Ying T, Moore KH. Long-term vaginal ring pessary use: discontinuation rates and adverse events. BJOG. 2009;116(13):1715–1721. 13. Friedman S, Sandhu KS, Wang C, et al. Factors influencing long-term pessary use. Int Urogynecol J. 2010;21(6):673–678. 14. Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA. 1995; 273(1):59–65. 15. Ferrans CE, Zerwic JJ, Wilbur JE, et al. Conceptual model of health-related quality of life. J Nurs Scholarsh. 2005;37(4):336–342. 16. Bakas T, McLennon SM, Carpenter JS, et al. Systematic review of health-related quality of life models. Health Qual Life Outcomes. 2012;10:134. 17. Groll DL, To T, Bombardier C, et al. The development of a comorbidity index with physical function as the outcome. J Clin Epidemiol. 2005; 58(6):595–602. 18. Wren PA, Janz NK, Brubaker L, et al. Reliability of health-related quality-of-life measures 1 year after surgical procedures for pelvic floor disorders. Am J Obstet Gynecol. 2005;192(3):780–788. 19. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1:385–401. 20. Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705–714. 21. Rannestad T, Skjeldestad FE. Ferrans and Powers' quality of life index applied in urinary incontinence research—a pilot study. Scand J Caring Sci. 2011;25(2):410–416. 22. Ferrans CE, Powers MJ. Psychometric assessment of the quality of life index. Res Nurs Health. 1992;15(1):29–38. 23. Alperin M, Khan A, Dubina E, et al. Patterns of pessary care and outcomes for medicare beneficiaries with pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2013;19(3):142–147.
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