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Genitourinary syndrome of menopause (GSM), formerly known as vulvovaginal atrophy and atrophic vaginitis, includes urinary symptoms (e.g., recurrent urinary tract infections, dysuria, and urgency), sexual symptoms (e.g., impaired function, pain or discomfort, and lack of lubrication), and genital symptoms (e.g., irritation, dryness, and burning; Marino, 2021). Reports suggest this syndrome affects more than 50% of postmenopausal women (Marino, 2021; Nik Hazlina et al., 2022).
Health-related quality of life (HRQoL) is a widely used multidimensional concept that covers the emotional, physical, and social components of specific diseases or treatments and represents the overall health of an individual (Colwell et al., 1998). Assessing HRQoL in women is critical to identifying individuals with poor health and suggesting appropriate intervention options to improve their health status.
Kegel's exercise, a pelvic floor muscle training (PFMT) exercise program, is a noninvasive therapy that improves pelvic floor muscle (PFM) power, endurance, relaxation, and strength (Huang & Chang, 2022). Arnold Henry Kegel was an American gynecologist who invented Kegel's exercise. This exercise has been employed in workout programs based in Chinese Taoism for over 6,000 years and was first used in modern medicine in 1936 (Dumoulin et al., 2018). The results of prior studies have shown Kegel's exercise to be an effective therapy for urinary incontinence (UI) in women. UI symptoms include involuntary urine leakage, urine loss, uncontrollable urges to urinate, frequent urination, and urinating during sleep (Cacciari et al., 2019; Dumoulin et al., 2018; Radzimińska et al., 2018). In addition, PFMT has been shown to improve quality of life (QoL) in women with UI, which is a crucial factor in their mental, physical, and social well-being (Radzimińska et al., 2018). However, the effectiveness of PFMT therapy in mitigating the symptoms of GSM has not been synthesized or shown. To date, no systematic review has been conducted to investigate the effectiveness of Kegel's exercise in postmenopausal women with GSM. In addition, the effectiveness and outcomes of Kegel's exercise in the context of the QoL of these women have not been summarized. Knowing whether this exercise provides an effective approach to reducing GSM severity in this population is important if healthcare provider professionals are to provide an evidence-based therapy option to women with GSM as well as help them reduce the burden of this condition.
ObjectiveThe aim of this study was to systematically review and analyze studies whether Kegel's exercise (I) enhances HRQoL (O) in postmenopausal women with GSM (P).
In this review study, HRQoL was measured using both general and condition-specific tools. As general tools typically do not include questions addressing specific diseases or conditions, specific tools that evaluate specific conditions are preferable. In this study, we included studies that assessed HRQoL using general instruments or specific measurements related to the impact of urinary symptoms, sexual function, and genital symptoms on postmenopausal women with GSM.
Methods Eligibility CriteriaThe inclusion criteria were (a) randomized controlled trial (RCT) format, (b) articles published in English with the full-text version available, (c) targeted postmenopausal women with genitourinary syndrome, (d) applied Kegel's exercise or PFMT, and (e) used HRQoL measurements. Postmenopausal women diagnosed with cancers or cardiometabolic diseases were excluded.
Searching StrategiesWe searched for pertinent studies in six electronic databases, including Embase, MEDLINE, Cochrane, CINAHL, Web of Science, and Scopus, between their respective dates of inception up to November 5, 2021. In addition, we searched for gray literature in ProQuest Dissertations and Theses. In addition, further articles were manually searched and retrieved by screening the references included in previous systematic reviews (Figure 1). Some prespecified search terms such as postmenopause, genitourinary syndrome, vulvovaginal atrophy, atrophic vaginitis, urinary incontinence, lower urinary tract symptoms, Kegel's exercise, PFM training, and quality of life were employed and modified for each database to produce the most precise findings. These terms were searched using the following text string: “postmenopause AND ([genitourinary syndrome] OR [vulvovaginal atrophy] OR [atrophic vaginitis] OR [urinary tract infection] OR [urine incontinence]) AND ([Kegel's exercise] OR [pelvic floor muscle training]) AND (health related quality of life).” We also used terms related to randomized clinical trials and RCT studies.
Figure 1.: Preferred Reporting Items for Systematic Reviews and Meta-Analyses DiagramNote. GSM = genitourinary syndrome of menopause; CG = control group; QoL = quality of life.
Study SelectionTwo researchers screened titles and abstracts independently using the above criteria. The full texts of the selected articles were carefully assessed to fully understand their final conclusions, and any conflicts among the researchers were resolved through discussion and consensus. This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to ensure the quality of the systematic review and meta-analysis report was sufficient (Page et al., 2021).
Data ExtractionAn Excel table was developed to record the extracted data. Data from each article were extracted by two authors independently, and any differences in opinion between them were resolved first through mutual discussion and consensus and, if needed, second through discussions with a senior author who had the authority to make a final determination. Potentially duplicated data were verified using the location of recruitment and the year, with only the largest of the two data sets retained in the final analysis. We extracted all data from graphs, tables, texts, and supplementary materials. For each article, information on intervention characteristics was recorded, including number of sessions, frequency, positions, length of follow-up, and control protocol. The information recorded on study characteristics included the first author's name, title of the article, year of publication, study designs, recruitment time, research location, sample size (in total and per group), and inclusion and exclusion criteria. In addition, data on participant characteristics (age and body mass index [BMI]) and study results were recorded with the name of QoL measurement and QoL scores (baseline and after intervention).
Appraisal of Study Quality and Risk of Bias in the StudiesA quality appraisal was performed using the Cochrane Collaboration “risk-of-bias assessment” tool Version 6.4 (Higgins et al. 2023). Two authors assessed the quality of the included studies independently. The assessed criteria included randomization method, allocation concealment, blinding of participants and investigators, blinding of assessors, incomplete outcome data, and selective outcome reporting. All of the discrepancies were resolved by consensus or through consultation with the senior author.
Summary measures and synthesis of resultsReview Manager Version 5.4 software was used to perform a meta-analysis with a 95% confidence interval (CI). The random-effects model was chosen when heterogeneities were present among the studies (Langan et al., 2019). Total mean and standard deviation (SD) scores were retrieved from the data sets of the included studies for statistical analysis. Chi-square and I2 tests were used to evaluate heterogeneity among the studies, with I2 > 50% indicating significant heterogeneity (Zintzaras & Lau, 2008). Finally, subgroup analysis was performed based on the symptoms identified from responses on the QoL questionnaires.
The effect size of the outcome measures was integrated using standardized mean differences (SMDs) because of the variety of instruments used to measure HRQoL across the included studies. SMD is a measure of effect size that is determined by dividing the difference in mean values by the pooled SDs of groups. Following Andrade (2020), an effect size of 0.2 ≤ SMDs ≤ 0.4 was defined in this study as small, 0.5 ≤ SMDs ≤ 0.7 as moderate, and SMDs ≥ 0.8 as large. The meta-analysis in this study was designed to evaluate precision (CIs), consistency (forest plots and tests for heterogeneity), and strength of association (SMDs). These domains were evaluated qualitatively, and after a discussion between two of the authors, the strength of evidence was rated as insufficient, low, moderate, or high.
Results Characteristics of Included StudiesOne hundred fifty-eight articles were identified in, respectively, the search of the six databases and the additional manual search process. After initial examination, five RCTs were qualified and included in the review. The literature search process is illustrated in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram in Figure 1 (Page et al., 2021). The publication dates of the selected studies ranged from September 2006 to November 2015. Four of the selected studies were conducted in Western countries (three in Brazil and one in Canada), and one was conducted in Asia (Iran; Table 1; Nazarpour et al., 2018).
Table 1. - Characteristics of the Included Studies Author (Year), Country Recruitment Time Sample Size (n) Age, Mean (SD; Years) BMI, Mean (SD) Intervention Protocol Control Protocol Length of Follow-Up Measurement IG CG IG CG IG CG Bertotto et al. (2017), Brazil Jan to Sep 2014 15 14 59.3 (4.9) 57.1 (5.3) 27.7 (3.6) 26.8 (3.6) Sessions: 8Note. IG = intervention group; CG = control group; BMI = body mass index; ICIQ-SF = International Consultation Incontinence Questionnaire-Short Form; FSFI = Female Sexual Function Index; KHQ = King's Health Questionnaire; IIQ = Incontinence Impact Questionnaire.
Two hundred sixty-eight postmenopausal women were enrolled in selected studies, with 136 in the Kegel's exercise groups and 132 in the control groups. Number of participants per group varied from 14 to 50. Three of the studies compared the effectiveness of Kegel's exercise with no intervention (Bertotto et al., 2017; Franco et al., 2021; Pereira et al., 2012), whereas two compared Kegel's exercise withal education programs (Nazarpour et al., 2018; Sran et al., 2016).
The baseline characteristics of the participants such as age and BMI were similar between the exercise and control groups. The mean age of the participants ranged from 53 to 67 years, and their mean BMI ranged from 23.1 to 28.7 kg/m2. This review only considered studies on postmenopausal women. Three studies defined postmenopause as the cessation of a menstrual period for a length of time or as the absence of vaginal bleeding for 12 consecutive months (Franco et al., 2021; Nazarpour et al., 2018; Pereira et al., 2012).
Description of the InterventionsThe Kegel's exercise programs investigated in the selected studies consisted of eight to 12 individual sessions of 20–40 minutes each and held twice a week (Bertotto et al., 2017; Nazarpour et al., 2018; Sran et al., 2016). Before beginning the exercise, the participants were required to empty their bladders. Exercise contained contraction movements in the PFMs. The women were instructed solely on methods of tightening the PFMs while avoiding contractions of other muscles (e.g., abdomen, thighs, or buttocks; Nazarpour et al., 2018). Most of the intervention sessions were performed standing (Bertotto et al., 2017; Franco et al., 2021; Pereira et al., 2012), sitting (Bertotto et al., 2017; Franco et al., 2021; Pereira et al., 2012), kneeling on all fours (Franco et al., 2021), and lying supine (Bertotto et al., 2017; Franco et al., 2021; Pereira et al., 2012). Ten maximal voluntary and sustained contractions of PFMs for at least 6 seconds were included, followed by five rapid contractions (Franco et al., 2021). A 6-second pause was allowed between contractions. Women pulled their PFMs in and up as strongly as possible and held the contraction for 6 seconds before relaxing entirely (Franco et al., 2021). Those participants unable to maintain a contraction for the requisite time in the first session were instructed to begin with 5-second contractions and gradually increase the duration over a few weeks until the requisite duration was achieved (Nazarpour et al., 2018). Each session consisted of an average of 100 contractions, which included both phasic and tonic contractions, followed by a period of rest (Pereira et al., 2012). The intervention follow-up periods ranged from 4 weeks to 1 year.
Outcomes and Effectiveness of the Kegel's Exercise on Genitourinary SyndromeIn this review, three questionnaires were employed to assess HRQoL: the International Consultation Incontinence Questionnaire-Short Form (ICIQ-SF), the Female Sexual Function Index (FSFI), and the Incontinence Impact Questionnaire (IIQ). In addition, one general QoL questionnaire was used—the King's Health Questionnaire (KHQ). The accuracy, credibility, and psychometric qualities of all the questionnaires were confirmed clinically. The FSFI was used in two studies (Franco et al., 2021; Nazarpour et al., 2018). The 19-item FSFI was created as a multidimensional self-report tool for evaluating the essential aspects of female sexual function (Wiegel et al., 2005) and considers sexual function during the last 4 weeks, generating scores in the six different domains of arousal, desire, orgasm, pain, lubrication, and satisfaction (Wiegel et al., 2005). The ICIQ-SF tool is a questionnaire used in clinical practice and research around the world to assess the impact of urine incontinence frequency and severity on QoL (Tamanini et al., 2004). Three broad domains of the KHQ related to UI were chosen, including general health, incontinence impact, and gravity (Kelleher et al., 1997). The IIQ assesses the impact of UI on QoL in four areas: emotional health, physical activity, social interactions, and travel (Handa & Massof, 2004).
With regard to genitourinary syndrome, the effect of Kegel's exercise on the HRQoL of postmenopausal women with UI was evaluated in three studies (Bertotto et al., 2017; Pereira et al., 2012; Sran et al., 2016), with the remaining two assessing the effect of Kegel's exercise on sexual function (Franco et al., 2021; Nazarpour et al., 2018). Only two of the five studies reassessed HRQoL either 6 weeks or 1 year after the Kegel's intervention (Pereira et al., 2012; Sran et al., 2016). Significant improvements in the HRQoL of postmenopausal women with UI were observed in the experimental group but not in the control group (n = 3; Bertotto et al., 2017; Pereira et al., 2012; Sran et al., 2016). The mean scores for HRQoL measures in the intervention group decreased across all three studies from 11.1 to 4.3 on the ICIQ-SF (Bertotto et al., 2017), from 43.50 to 12.31 on the KHQ (Pereira et al., 2012), and from 54.84 to 11.11 on the IIQ (Sran et al., 2016).
After the interventions, no difference between groups was found in sexual function. However, the intervention groups had higher percentages than the control groups of women without sexual dysfunction (Franco et al., 2021; Nazarpour et al., 2018). The mean scores of the FSFI for sexual function ranged from 22.7 to 24.5 in the intervention groups and from 21.9 to 22.5 in the control groups (Table 2).
Table 2. - Total HRQoL Scores in the Included Studies Author (Year) Measurement Baseline After Intervention (4–12 Weeks) 6 Weeks to 1 Year After the End of Intervention IG CG IG CG IG CG Mean SD Mean SD Mean SD Mean SD Mean SD Mean SD Bertotto et al. (2017) ICIQ-SF 11.1 2.9 11.1 4.5 4.3 3.2 10.0 4.8 – – Franco et al. (2021) FSFI 22.7 4.7 21.9 6.3 24.5 4.6 22.4 5.4 – – Nazarpour et al. (2018) FSFI 23.9 5.8 22.9 6.7 23.5 0.6 22.5 0.5 – – Pereira et al. (2012) KHQ 43.5 29.0 48.9 26.2 21.0 21.8 45.7 24.0 12.3 9.9 – Sran et al. (2016) IIQ 54.8 51.1 50.7 60.7 15.3 28.5 50.3 65.9 11.1 20.8 31.7 54.2Note. HRQoL = health-related quality of life; IG = intervention group; CG = control group; ICIQ-SF = International Consultation Incontinence Questionnaire-Short Form; FSFI = Female Sexual Function Index; KHQ = King's Health Questionnaire; IIQ = Incontinence Impact Questionnaire.
A subgroup analysis comparing the effect of Kegel's exercise on HRQoL in postmenopausal women with urinary symptoms showed Kegel's exercise significantly improved the HRQoL of the participants (three studies, SMD = −0.95, 95% CI [−1.35, −0.54], I2 = 0%; Table 3). Findings from another subgroup analysis of sexual symptoms indicate Kegel's exercise had no effect on the sexual-symptom-related HRQoL in postmenopausal women (two studies, SMD = 1.11, 95% CI [−0.25, 2.47], I2 = 94%; Table 3). Because only five studies were included in this meta-analysis, analyses of publication bias and meta-regression could not be conducted.
Table 3.: Forest Plot
Quality Within StudiesThe risk-of-bias assessment results for the selected studies are summarized in Figure 2. All of the studies used a genuinely random sequence (e.g., computer-generated random assignment or random-number table) to assign subjects to study groups. Four of the studies reported allocation concealment adequately, with the remaining study regarded at a high risk of allocation bias because no information was provided regarding allocation concealment (Nazarpour et al., 2018). All of the studies were rated as unclear in terms of participant and personnel blinding (performance bias), as it is not generally feasible to blind participants or care providers in this type of study. Three of the selected studies reported using blinded outcome evaluation (Franco et al., 2021; Pereira et al., 2012; Sran et al., 2016), whereas two did not report sufficient information to conclude whether the outcome assessments had been blinded (Bertotto et al., 2017; Nazarpour et al., 2018).
Figure 2.: Risk of Bias for the Included Randomized Controlled TrialsNote. 
low risk of bias with sufficient detail; 
unclear risk of bias with inadequate information; 
high risk of bias with sufficient detail.All of the studies reported attrition, dropouts, and losses to follow-up. Four studies reported less than a 10% proportion rate, and three studies reported relatively higher proportions of withdrawal or loss to follow-up in the control group (Bertotto et al., 2017; Pereira et al., 2012; Sran et al., 2016). Only one did not report their trial protocol through a trial registry (Pereira et al., 2012). All of the studies were comparable at baseline for all important outcomes and demographic characteristics that may be predictors of outcomes, such as symptom severity or duration. Three of the studies stated that the primary analysis was by intention-to-treat (Franco et al., 2021; Pereira et al., 2012; Sran et al., 2016). One study reported data only for participants who had reached time points for outcomes (Bertotto et al., 2017). Four of the studies were identified as having a low risk of bias because they reported potential and prespecified outcomes.
DiscussionA comprehensive systematic review and meta-analysis was performed to determine whether Kegel's exercise could enhance the HRQoL of postmenopausal women with GSM. Five studies were retrieved and analyzed. The quality of these studies was assessed, with most found to have a low risk of bias.
The findings of this review indicate Kegel's exercise significantly improves urinary-symptom-related HRQoL in postmenopausal women and that Kegel's exercise can improve urinary symptoms such as urine leakage in this population because its strengthening of the PFMs can reduce UI (Di Benedetto et al., 2008). Kegel's exercise strengthens the PFMs, making the muscles under the uterus stronger and supporting the bladder, which keeps these muscles fit and prevents their sagging into the vagina (Di Benedetto et al., 2008).
Although PFMs play a role in sexual function (Angelini, 2017), no evidence was found that Kegel's exercise affects the sexual symptoms related to HRQoL. Many factors contribute to sexual symptoms during the postmenopausal period, including biological (e.g., decreases in sex hormones), interpersonal (e.g., sexual dysfunction in a sexual partner), psychological (e.g., development of mood symptoms), and sociocultural (e.g., negative stigma around sexuality in older women) processes (Thomas et al., 2019). In particular, lower estrogen levels significantly affect sexual symptoms in postmenopausal women, such as lack of lubrication, discomfort or pain, and impaired sexual function (Shirvani & Heidari, 2016). Therefore, strengthening PFMs using Kegel's exercise alone without addressing the other predisposing factors may not alleviate or reduce these sexual symptoms.
Furthermore, the evidence in support of Kegel's exercise improving genital-symptom-related HRQoL in postmenopausal women was inadequate. Future studies should evaluate the impact of Kegel's exercise on HRQoL in postmenopausal women with genital symptoms (e.g., irritation, dryness, and burning).
Relevance to Clinical PracticeA well-structured standard Kegel's exercise protocol may be designed for postmenopausal women with GSM to maximize the therapeutic use of Kegel's exercise in clinical practice. Patients should perform Kegel's exercise three times a day (morning, afternoon, and night) by first making sure their bladder is empty before starting and then standing, sitting, kneeling, or lying down. PFMs should be held tight for 3–5 seconds and then relaxed before repeating. Patients should repeat the tightening and relaxing routine at least 10 times per session. While doing the exercise, patients should breathe deeply, relax their bodies, and make sure not to tighten their stomach, thighs, buttocks, or chest muscles. For postmenopausal women with GSM, the Kegel's exercise routine is a cost-effective and educational tool for improving HRQoL. Nurses and other healthcare providers should educate patients and their families on how to perform the exercise properly and contract their PFMs correctly.
LimitationsTo our knowledge, this was the first systematic review of HRQoL related to the Kegel's exercise routine in postmenopausal women with genitourinary syndrome. The strengths of this review include its rigorous methodology, systematic search strategy, and predetermined inclusion and exclusion criteria. However, some limitations should be considered. First, only five RCTs were included. Thus, statistical power was inadequate because of the small sample size. Second, we limited our search to publications written in English, which may have resulted in the omission of potential studies in other languages. Third, we reported SMDs rather than mean differences, as various outcome measures were used in the selected studies. However, one important limitation of using SMD is that it is still a statistical concept that may be difficult to interpret clinically, given that the clinical relevance of an SMD depends on the content (Cuijpers, 2021). Furthermore, variations existed in intervention sessions and follow-up periods across the selected studies. The exercise programs in these studies were highly heterogeneous in terms of both follow-up duration and HRQoL outcome measurements.
Because most of the RCTs included in this analysis were short-term studies, we were not able to establish longer-term (> 1-year) effects of the Kegel's exercise. These longer-term effects should be investigated in future research to expand scientific knowledge regarding the overall benefit of the Kegel's exercise on HRQoL in postmenopausal women with GSM-related urinary, sexual, and genital symptoms.
ConclusionsThe results of this systematic review and meta-analysis support that Kegel's exercise reduces HRQoL-related urinary symptoms in postmenopausal women with GSM. However, no evidence was found that this exercise affected HRQoL-related sexual symptoms. The effect of Kegel's exercise on genital symptoms has not been rigorously investigated. In conclusion, we recommend Kegel's exercise as a useful intervention to improve the urinary symptoms affecting HRQoL in postmenopausal women.
AcknowledgmentsThe authors appreciate the staff of Kun-Yen Medical Library, National Cheng Kung University, Tainan, Taiwan, for their valuable literature search advice as well as Dorothy L. Culjat, MS, former lecturer, Medical English, Faculty of Nursing, Duy Tan University, for proofreading assistance.
Author ContributionsStudy conception and design: TTBN, YYH
Data collection: YPS, TTBN
Data analysis and interpretation: TTBN, YYH
Drafting of the article: TTBN, YPS
Critical revision of the article: YYH
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