Pelvic floor dysfunction (PFD) encompasses urinary incontinence, fecal incontinence, pelvic organ prolapse, sexual dysfunction, and other genitourinary symptoms
[1-2]. Which is prevalent among women during pregnancy and postpartum period, often presenting with one or more symptoms. Although PFD is rarely fatal, it can severely influence patients’ quality of life and impede their ability to engage in daily activities
[3].
Pregnancy and childbirth are independent risk factors for PFD
[4]. An epidemiological study
[5] reported that 46.1% of pregnant women experience at least one symptom of PFD. Despite a high prevalence rate, only 25% of patients with PFD in the United States and 9% in China seek medical attention
[6-7]. Given the high prevalence of PFD and low consultation rates, its early screening, assessment, intervention, and rehabilitation are essential.
Clinicians require effective tools to assess the prevalence and severity of PFD symptoms. Questionnaire is practical, efficient, and convenient for initial screening and early detection of PFD during pregnancy and postpartum period
[8]. Several validated questionnaires, such as the Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
[9], are used to assess the frequency and severity of PFD symptoms and their impact on quality of life. However, these tools primarily focus on a broader range of female populations and are not specifically tailored to the unique needs of pregnant women and those in postpartum stage.
The PFDI-20 and PFIQ-7 are comprehensive tools designed for general female populations with PFD symptoms. While they are valuable for assessing various aspects of PFD and its impact, they may not fully capture the specific symptoms and challenges experienced by pregnant and postpartum women. Moreover, these existing questionnaires are not sufficient to address the unique physiological changes and rehabilitation needs associated with pregnancy and the postpartum period. Pregnancy, labor, delivery, and the postpartum period are associated with a high incidence of PFD and rehabilitation needs
[10]. The Pregnant and Postpartum Women, being specifically designed for this population, offers a more targeted assessment of pelvic floor health during these crucial stages, potentially providing more relevant insights for both clinical practice and research.
The German version of the Pelvic Floor Questionnaire for Pregnant and Postpartum Women (PFQPW) is a self-administered female pelvic floor questionnaire, specifically designed for women in the pregnancy and postpartum periods by Metz, et al
[11] in 2017. This questionnaire is used to evaluate the severity and prevalence of PFD symptoms and their impact on individuals’ ability to perform daily life activities. Although the German version of the PFQPW has been translated into several languages, including Italian
[12], Turkish
[13], Swedish
[8], and Portuguese
[14], the cultural context and healthcare system in China present unique challenges and considerations.
Thus, in this study, the PFQPW was translated, cross-culturally adapted, and validated to assess its applicability for Chinese women in pregnancy and postpartum stages, contributing to the availability of effective tools in this field.
1 Materials and methods
1.1 Ethics statement
The study protocol was approved by the Research Ethics Committee of the Third Xiangya Hospital, Central South University (No. 22283). Prior to their participation, all individuals provided informed consent after receiving a comprehensive ethical explanation regarding the potential risks and benefits of this clinical trial. This study was registered with the China Clinical Trial Center (ChiCTR2200066315).
1.2 Questionnaire
1.2.1 Questionnaire introduction
A questionnaire was used based on the validated German Pelvic Floor Questionnaire, which focuses on 4 domains of pelvic floor function in pregnant and postpartum women: Bladder function (16 items), bowel function (11 items), prolapse symptoms (6 items), and sexual function (12 items). In addition, it contains 2 supplementary domains: Risk factors (questions on the family history of associated disorders, lifestyle, and pelvic floor muscle activity) and labor and delivery history (questions on the number and type of previous deliveries, mood assessment, and pain-related aspects). The last question in each domain of the questionnaire is “How much do your bladder/bowel/prolapse/sexual symptoms bother you”. This question assesses the impact of the symptoms on quality of life. The responses “a little” “quite a lot” and “a lot” indicate that the symptoms are bothersome and were dichotomized accordingly in this study. The remaining items were rated on a scale of 0 to 3, with a higher score indicating more severe symptoms.
1.2.2 Questionnaire translation
Translations and cultural revisions were based on the standardized cross-cultural adaptation guidelines. Permission for translation, adaptation, and validation was obtained from the authors of the original questionnaire. First, the original questionnaire was translated into Chinese by a clinician with expertise in pelvic floor rehabilitation and a native Chinese speaker proficient in German. Both translators were unfamiliar with the original questionnaire and performed the translations independently, which resulted in 2 directly translated versions (Q1 and Q2). Subsequently, these 2 translators and the clinical research team integrated, discussed, and modified the 2 direct-translated versions until a consensus was reached, forming the combined Chinese version Q3. An overseas-based medical professor and a graduate medical student, both of whom had passed College English Test Band 6, independently translated the Chinese version of the questionnaire, Q3, into English, resulting in the back-translated versions Q4 and Q5, respectively. These versions were further discussed and modified by the research team to account for cultural differences, resulting in the Chinese version Q6. The original questionnaire and the back-translated version were compared in accordance with the questionnaire’s guidelines for cross-cultural adaptation and reviewed by a panel of 6 experts consisting of professors of obstetrics and gynecology, urology, and pelvic rehabilitation therapy. All experts received the original questionnaire and the Chinese versions Q3 and Q6. The experts evaluated the semantic equivalence, idiomaticity, content of the entries, and cultural variability of the Chinese version Q6 based on their theoretical knowledge and clinical experience. The research team revised each version in accordance with experts’ comments to create the pretest version.
1.2.3 Pretesting
Using the convenience sampling method, 10 patients with PFD who received treatment at the pelvic floor rehabilitation center of the Third Xiangya Hospital between December 2022 and March 2023 were selected. The researcher explained the purpose and significance of the study to the patients before distributing the questionnaires and obtaining their informed consent. Subsequently, the patients were asked to evaluate their perceived level of difficulty in understanding each item and its corresponding answer. In addition, they were asked to identify any items in the questionnaire that they found to be ambiguous or challenging to understand. Based on the feedback received from the patients, final revisions and corrections were made to the questionnaire to produce the final Chinese version of the questionnaire.
1.3 Questionnaire reliability and validity tests
1.3.1 Study population
From December 2022 to June 2023, participants were recruited at the Department of Rehabilitation Medicine, the Third Xiangya Hospital, Central South University, China. Inclusion criteria were as follows: 1) Women aged >18 years; 2) either in late pregnancy or within <6 months postpartum; 3) capable of understanding and independently completing the questionnaire; and 4) voluntary participation in the study. Exclusion criteria were as follows: 1) Presence of neurological diseases; 2) not being a native Chinese speaker; 3) mental illness or severe conditions, such as heart disease; 4) history of pelvic surgery; 5) history of preterm delivery; 6) malignant tumors in the pelvic region or pelvic fracture, genitourinary malformations, or receiving medications for bladder or bowel function; 7) low intellectual ability and inability to comprehend the questionnaires; and 8) unwillingness to participate in the study.
1.3.2 Data collection
According to the sample size calculation method, the sample size should be 10-15 times of the number of dimensions in the questionnaire
[15]. Because the questionnaire in this study comprised 4 dimensions, the sample size for the study was estimated to be 40-60. Considering a 15% loss to follow-up rate, a sample size of 46-69 was deemed to be appropriate. A Chinese online survey software (Wenjuanxing) was used to generate an electronic questionnaire for the survey. Eligible participants who met the inclusion criteria were invited to complete the questionnaire. To prevent duplicate responses, questionnaire responses from each IP address were allowed only once. The completed data were reviewed and analyzed on a regular basis. In case of any errors or inaccuracies, immediate steps were taken to correct them or the information was verified with the patient to ensure the quality and reliability of the final data.
In the first week, 72 participants completed the questionnaire. To examine the retest reliability of the questionnaire, all the participants were asked to complete the questionnaire again one week later, and 37 of the 72 participants completed the second-round questionnaire.
After data collection, the data were exported from the Wenjuanxing software and were reviewed individually by 2 researchers responsible for data organization.
1.3.3 Reliability and validity test of the questionnaire
The reliability of the questionnaire was calculated based on Cronbach’s α coefficients, retest reliability, and folded-half reliability. Cronbach’s α coefficient evaluated the internal consistency and reliability of the total scale and individual dimensions. A Cronbach’s α value greater than 0.7 was considered acceptable, indicating good reliability. The intraclass correlation coefficient (ICC) was calculated to determine retest reliability, with an ICC value greater than 0.7 suggesting good reliability. Folded-half reliability was calculated by dividing the number of items in half and calculating the Spearman-Brown coefficient. A Spearman-Brown coefficient greater than 0.7 was considered acceptable, indicating good reliability.
Six experts were invited to evaluate the questionnaire items, and an item-level content validity index (I-CVI) and a scale-level content validity index (S-CVI) were calculated to determine the content validity of the questionnaire. The I-CVI was calculated on the basis of the proportion of experts who rated the items as 3 (relevant) or 4 (very relevant) on a 4-point Likert scale. The S-CVI was calculated as the average of the I-CVI. The I-CVI≥0.7 and S-CVI≥0.9 are considered to denote good content validity
[16].
Structural validity of the questionnaire was examined to determine its ability to differentiate between women with and without PFD symptoms. The question “How much does your bladder/bowel/prolapse/sexual symptoms bother you” was used to establish a “case group” and a “control group.” The participants who responded with “not applicable, I do not have symptoms” or “not at all” were included in the control group, whereas those who answered with “a little” “quite a lot” or “very much” were included in the case group.
1.4 Statistical analysis
The collected data were analyzed using SPSS 25.0. Continuous data with normal distribution are presented as mean and standard deviation, while non-normally distributed continuous data are presented as median (1st quartile, 3rd quartile). Dichotomous data are presented as the frequency and percentage. Both the reliability and validity of the questionnaires were evaluated.
The Mann-Whitney U test was used to compare median scores for each dimension to distinguish between women with and without symptoms. Normally distributed data were compared between the 2 groups by using independent-samples t test, whereas skewed data were compared using the Mann-Whitney U test to examine between-group variability.
2 Results
2.1 Demographic characteristics
A total of 72 participants completed the questionnaire, including 5 women in late pregnancy and 6 months postpartum, with no missing items. The mean age of the participants was (32.3±3.6) years, and the mean number of deliveries was (1.5±0.8). Furthermore, 17 women with perineal tears were identified, and nearly half (44.4%) of the participants reported to have experienced perineal pain. Three (4.1%) women reported inability to contract the pelvic floor muscles (
Table 1).
2.2 Scale validity tests
2.2.1 Content validity
Six clinical experts were invited to assess the content validity of the questionnaire. The results revealed that the I-CVI for all items in the questionnaire ranged from 0.833 to 1.000 (ICC>0.78), and the S-CVI (S-CVI/Average) for the scale was 0.977 (ICC>0.90).
2.2.2 Structural validity
Analysis of the prevalence of PFD symptoms in the study population showed that sexual and bladder symptoms were the most prevalent (40.3% and 27.8% of the total, respectively), whereas bowel symptoms were the least prevalent (19.5%). The questionnaire effectively differentiated between symptomatic and asymptomatic patients in all the 4 domains of PFD. The scores in all the 4 domains significantly differed between the 2 groups. In terms of bladder, bowel, prolapse, and sexual functions, the median scores of symptomatic patients were at least 1 point higher than those of asymptomatic women (
Table 2).
2.3 Scale reliability tests
2.3.1 Reliability analysis
The Cronbach’s α coefficient of the total scale was 0.891, whereas the Cronbach’s α coefficients of its 4 dimensions ranged from 0.732 to 0.884, indicating that the internal consistency of the questionnaire is satisfactory. The missing data for any item in the questionnaire did not exceed 4% (
Table 3).
2.3.2 Retest and folded-half reliability analyses
Thirty-seven study participants were tested after 1 week. The results revealed that the retest reliability of the total scale was 0.833. The retest reliabilities of bladder, bowel, prolapse, and sexual functions were 0.776, 0.579, 0.732, and 0.645, respectively, consistent with the coefficients of the first test. The folded-half reliability was 0.74.
3 Discussion
This study involved a questionnaire survey to evaluate the symptoms, prevalence, severity, risk factors, and impact of PFD on quality of life of women during pregnancy and postpartum. The results indicate that the questionnaire is reliable and valid for the Chinese population, which aligns with findings from validations in Italy
[12], Turkey
[13], Sweden
[8], and Brazil (in Portuguese)
[14], further supporting the universality of the tool.
While the reliability and validity of the Chinese version of the questionnaire align with previous validations, this study provides new insights by considering the unique cultural and healthcare context of China. The Italian
[12], Turkish
[13], Swedish
[14], and Portuguese
[15] versions of the questionnaire may not fully capture the nuances of PFD among Chinese women due to differences in sociocultural factors, healthcare access, and attitudes toward women’s health between China and other countries. For instance, in China, traditional attitudes toward women’s health may make many women reluctant to seek medical help for pelvic floor issues. This cultural background might explain the relatively low reporting rate (40.3%) of sexual function problems in our study. Compared to Western countries, Chinese women may be more reserved in expressing and discussing sexual health issues, suggesting that more sensitive and open communication approaches must be adopted in clinical evaluations to encourage women to express their true feelings and needs. Our findings not only validate the PFQPW for a new population but also underscore the importance of culturally sensitive approaches in the assessment and management of pelvic floor disorders. This research highlights the value of localized tools in improving the identification and treatment of these disorders across diverse populations.
In this study, the German version of the PFQPW was translated and pretested in accordance with the WHO guidelines for cross-cultural research and Brislin’s translation model. The questionnaire was then revised and adjusted according to the pretest results and experts’ opinion, resulting in a clear and easy-to-understand Chinese version of the PFQPW. Moreover, the questionnaire can be completed in only approximately 5 min, highlighting its brevity, clarity, and user-friendliness.
The results in
Table 2 suggest that about two-fifths (40.3%) of the women had problems with sexual function, consistent with the findings of previous study
[17] that problems with sexual function are present in 50%-83% of women with PFD. Therefore, to gain a clearer understanding of sexuality, it may be necessary to give patients the opportunity to explain and justify themselves in the clinic. Our study found that 19.5% of women reported to have intestinal symptoms, which is consistent with the previous study
[18] (the prevalence of fecal incontinence varies from 2.0% to 20.7%). This result suggests that although PFD manifests differently in patients, attention should be paid to the interrelationships between different symptoms and their overall impact on women’s quality of life. Future research could explore the underlying mechanisms of different types of pelvic floor disorders and the potential role of integrated interventions in improving overall patient’s health.
The reliability test results for the Chinese version of the PFQPW were similar to those of its German version. When analyzing internal consistency, Cronbach’s α coefficients for the dimensions of the Chinese version of the questionnaire ranged from 0.732 to 0.884. These values are consistent with those reported in the original study
[11] and those in studies conducted by Palmieri, et al
[12] and da Silva Vieira, et al
[14]. Cronbach’s α assesses the degree of correlation of each item in the questionnaire with the other items
[19]. Therefore, the results suggested the reliability of the Chinese version of the PFQPW. The retest reliability, which reflects external reliability, was evaluated, and according to Fleiss, et al
[20], ICC was classified as weak (ICC<0.4), moderate (0.4≤ICC≤0.7), and strong (ICC>0.7). The ICC for the total scale was 0.833 in this study, which further supports the questionnaire’s reliability, indicating its consistency and dependability. We anticipate that this instrument will fill the gap in both clinical practice and research by aiding in the history-taking process, documenting symptoms, and evaluating treatment effects for physiotherapists.
Validity mainly refers to the extent to which a particular instrument can actually measure the desired outcome
[21]. In this study, both the content and structural validity of the scale were measured. Content validity refers to the extent to which the entries of a measurement instrument reflect the content of the measurement
[22]. The results of this study revealed that the Chinese version of the scale had an I-CVI of 0.833 to 1.000 (ICC>0.78) and an S-CVI (S-CVI/Average) of 0.977 (ICC>0.90), indicating that the real content of the scale is highly consistent with the content to be measured. Structural validity assesses the overall quality of the questionnaire and its ability to accurately measure the variables of interest
[23]. The results indicated that the median scores of symptomatic patients were all at least 1 point higher than those of asymptomatic patients, indicating that the Chinese version of the scale could effectively differentiate between women with and without PFD symptoms. Therefore, this self-administered questionnaire can help physiotherapists in China in accurately assessing and identifying all aspects of PFD in pregnant and postnatal women.
The limitation of this study should be acknowledged. First, most participants were in the postpartum stage and attending the rehabilitation department; thus, they could pay sufficient attention to PFD and had relevant medical knowledge. This may have introduced a selection bias, leading to biased measurement results. A broader target group with varied background and more basic knowledge of the Chinese language would be desirable. Second, although, the sample size included in this study was small, and only 7% of the participants were in late pregnancy, we applied statistical methods appropriated for small samples to enhance analytical robustness. However, the insufficient sample size might still compromise the reliability and external validity of the findings; therefore, results should be interpreted with caution. Future research should be conducted with a larger sample size to validate the findings of this study and improve the reliability of the results. For women in pregnancy, the early identification, diagnosis, and treatment of PFD can reduce its potential risk. Therefore, future studies should focus on women in late pregnancy to ensure that the findings of such studies benefit more women.
The Chinese version of the PFQPW demonstrated excellent content and structural validity and was well understood by Chinese women in pregnancy and postpartum period. The questionnaire exhibits satisfactory internal consistency and retest reliability for individual questions and total scores across all PFD domains. Furthermore, the questionnaire could effectively differentiate between women with and without PFD. Thus, the Chinese version of the PFQPW is recommended for self-screening and assessment in clinical settings.
the Natural Science Foundation of Hunan Province(2024JJ6626)
the Hunan Provincial Key Laboratory of Regional Hereditary Birth Defects Prevention and Control(HPKL202320)
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