The International Consultation on Incontinence Questionnaire Short Form as a Substitute for 1-Hour Pad Weight Testing in the Evaluation of Urinary Incontinence in Patients With Pelvic Organ Prolapse Undergoing Surgery
Article information
Abstract
Purpose
Stress urinary incontinence is a postoperative complication occurring in patients with pelvic organ prolapse (POP). Although the 1-hour pad test measures the degree of urinary incontinence qualitatively and quantitatively, some elderly women undergoing POP surgery do not have the daily activities of living to perform the pad test. Therefore, we examined whether the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) could be used as an alternative tool for pad tests.
Methods
We retrospectively evaluated 132 patients with POP. In our hospital, 57 patients were treated by laparoscopic sacrocolpopexy (LSC), whereas 75 were treated by transvaginal mesh surgery (TVM). We measured the changes in symptoms preand postoperatively using the ICIQ-SF and 1-hour pad weight testing, and investigated the correlation between the total plus component question scores of the ICIQ-SF and 1-hour pad weight.
Results
The preoperative ICIQ total scores in all patients decreased significantly as the amount of leakage on the 1-hour pad weight decreased. The component question scores also decreased significantly with decreasing levels of 1-hour pad weight. The LSC and TVM groups had decreased ICIQ-SF total and component question scores as pad weight decreased. At 12 months postoperatively, the ICIQ total scores in all patients significantly declined as the amount of leakage on the 1-hour pad weight decreased. In the LSC group, the ICIQ-SF total and component question scores also decreased with decreased pad weight, but the differences were not always significant between ICIQ scores and pad weight. In the TVM group, the ICIQ-SF total and component question scores also significantly decreased as the pad weight decreased.
Conclusions
The ICIQ-SF could be an appropriate substitute for the 1-hour pad weight testing in predicting the severity of urinary incontinence. In the future, we hope to predict the level of urine leakage based on the ICIQ-SF score.
INTRODUCTION
Because pelvic organ descent causes urethral kinking, continence is considered to be preserved in cases of advanced pelvic organ prolapse (POP) [1]. In this context, occult stress urinary incontinence (SUI), defined as involuntary urine leaking during coughing, sneezing, or exertion [2,3], may also be defined as leaks upon induction following a repair of advanced POP [4]. SUI commonly occurs after repair surgery for POP [4,5]. A study reported that 8%–40% of patients with POP experience problematic SUI after POP surgery [6]. Surgery is often required to treat severe SUI.
Several evaluation techniques, such as pad weight testing, have been established to identify and quantify urinary incontinence (UI) severity [7-9]. The number of pads used is an easy way for patients to report the amount of urine leakage and 1-hour pad weight testing is the most widely used technique to evaluate UI because it is a simple means to assess its severity [10,11]. Pad weight measurement was considered a standard method because it provides a quantitative and objective evaluation of UI [12]. Some studies performed 24-hour pad weight testing, which was also useful in assessing the extent of incontinence [13,14], but distinguishing SUI from urge urinary incontinence (UUI) is difficult using a 24-hour pad test. Therefore, we applied a 1-hour pad test to measure the extent of SUI.
Conversely, as a patient-reported instrument, questionnaires may influence quality of life (QoL) and should preferably be validated. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is commonly used in outcome research. In this questionnaire, the total score is calculated from 3 component questions: the first and second questions ask patients to rate the subjective frequency and severity of their UI symptoms, respectively, and the third assesses the QoL specific to the condition, measuring the impact of UI with daily living on a scale from 0 (not at all) to 10 (a great deal) [15].
However, many elderly patients cannot perform the pad test because of a decline in activities of daily living. Instead, we also instructed them to fill in questionnaires, such as ICIQ-SF. This study aimed to investigate the correlation and level of agreement in detail between the total and component question scores of the ICIQ-SF and 1-hour pad weight. We also examined whether the ICIQ-SF could be used as an alternative tool for pad weight testing.
MATERIALS AND METHODS
Patients
We collected and evaluated the clinicopathological data from the medical records of 132 patients with POP who underwent laparoscopic sacrocolpopexy (LSC) or transvaginal mesh surgery (TVM) at our hospital between June 2013 and March 2023. We examined patients who underwent either surgery during this period for inclusion in this study but excluded those who did not provide consent forms. This is a retrospective study in which previous medical records were used for analysis. Indications for surgery included vaginal prolapse symptoms, which meant a POP quantification (POP-Q) stage of ≥2 in which pessary treatment was unsuccessful. The median follow-up period after surgery was 12.4 months (interquartile range, 12.2–24.8 months). We recorded age, median body mass index (BMI), POP-Q stage, type of surgery, blood loss, operative time, and major complications intraoperatively (Table 1). Table 2 shows the preoperative and 12-month postoperative ICIQ-SF scores and 1-hour pad weight testing results for the LSC and TVM groups.
Clinical characteristics of the enrolled patients (n=132)
ICIQ-SF score and pad weight of the enrolled patients
Surgical Procedure
Two urologists performed LSC and TVM as described in our previous paper [16].
Assessment Methods for Preoperative and Postoperative Parameters
The ICIQ-SF was used preoperatively and 12 months postoperatively to assess urinary incontinence. ICIQ-SF is available by logging in to the ICIQ Group website and agreeing to the terms and conditions (https://iciq.net/register). Preoperative and postoperative 1-hour pad weight testing were also evaluated. A 1-hour pad weight testing was conducted concurrently with the follow-up survey interview to measure UI objectively. Women were requested to use a preweighed extralong feminine pad. The pad was removed and weighed again after an hour, with the incremental change determined by taking the pad weight after an hour. This approach is frequently used for pre- and postoperative examinations.
The occurrence of postoperative urinary incontinence was defined by a daily life disturbance with urinary incontinence.
Statistical Analysis
The unpaired Student t-test and Mann-Whitney U-test were used to compare the differences in variable data between the LSC and TVM groups. Pearson chi-square test was used to determine the difference in POP-Q stage and 1-hour pad weight between the LSC and TVM groups. The Kruskal-Wallis test was used to evaluate the differences in ICIQ-SF total and component scores for each pad weight. Spearman rank correlation coefficient was used to evaluate the correlation between the ICIQ-SF scores and the 1-hour pad test measures. Statistical analysis was performed using JMP PRO (ver. 17; SAS Institute, Cary, NC, USA). A P-value <0.05 was considered statistically significant.
RESULTS
Patient Parameters
The patients’ median age was 72.4 years in the LSC group and 73.1 years in the TVM group, which showed no significant difference (P=0.545). The mean BMI was 22.4 kg/m2 in the LSC group and 24.9 kg/m2 in the TVM group, which showed a significant difference (P<0.001). Seven patients from the LSC group had stage 4, while 3 from the TVM group had stage 4, which showed a significant difference (P=0.020). The median blood loss was 2 mL in the LSC group and 26 mL in the TVM group, which showed a significant difference (P<0.001). The median operating time was 3.2 hours in the LSC group and 1.2 hours in the TVM group, which showed a significant difference (P<0.001) (Table 1). Major complications during surgeries were also shown in Table 1. Bladder injuries were seen in totally 4 patients; however, no serious postoperative complications were observed. All of them were rated as Clavien-Dindo classification grade 1 [17]. The ICIQ-SF total and component question scores, as well as 1-hour pad weight, did not differ preoperatively and 12 months postoperatively.
Relationship Between ICIQ-SF and 1-Hour Pad Weight Testing
The amount of incontinence was assessed using 1-hour pad weight testing, and the patients were asked to self-assess the degree of daily urine leakage using the ICIQ-SF.
The preoperative ICIQ total scores of all patients tended to decrease significantly as the amount of leakage on the 1-hour pad weight decreased. The median ICIQ total scores were 12, 11.5, and 10 in pad weights of >50, 10–50, and 5–10 g groups (P<0.001, P<0.001, P=0.001, respectively). The component question scores also decreased significantly with decreasing levels of 1-hour pad weight (all P<0.05) (Fig. 1A). In the LSC and TVM groups, the ICIQ-SF total and component question scores also decreased with a decrease in pad weight (Fig. 1B and C).
(A) Box plots show a significant relationship between pad weights of >50, 10–50, 5–10, and <2 g in the ICIQ-SF total score, ICIQ-SF Q1, and Q2 scores preoperatively. Pad weights of >50, 10–50, 5–10, 2–5, and <2 g were significantly associated with in ICIQSF Q3 score preoperatively. (B) In the laparoscopic sacrocolpopexy (LSC) group, box plots show a significant relationship between pad weights of >50, 10–50, and <2 g in the ICIQ-SF total score. Box plots also show a significant relationship between pad weights of >50 and <2 g in the ICIQ-SF Q1 score preoperatively. Pad weights of >50, 10–50, 5–10, and <2 g were significantly associated with the ICIQ-SF Q2 and Q3 scores. (C) In the by transvaginal mesh surgery (TVM) group, box plots show a significant relationship between pad weights of >50, 10–50, 5–10, 2–5, and <2 g in the ICIQ-SF total score. Pad weights of >50, 10–50, 5–10, and <2 g were significantly associated with ICIQ-SF Q1 and Q3 scores. Box plots also showed a significant relationship between pad weights of >50, 10–50, and <2 g in the ICIQ-SF Q2 score preoperatively. ICIQ-SF, International Consultation on Incontinence Questionnaire Short Form. *P<0.05, significantly different (all).
At 12 months postoperatively, the ICIQ total scores of both groups significantly declined as the amount of leakage on the 1-hour pad weight decreased. The median ICIQ total scores were 10, 8, 7, and 6 in pad weights of >50, 10–50, 5–10, and 2–5 g groups (P=0.0002, P<0.001, P=0.0001, P=0.0003, respectively). The component question scores also decreased significantly with decreasing levels of 1-hour pad weight (all P<0.05) (Fig. 2A). In the LSC and TVM groups, the ICIQ-SF total and component question scores also decreased as the pad weight decreased, but the differences were not always significant between ICIQ scores and pad weight in the LSC group (Fig. 2B and C).
(A) Box plots show a significant relationship between pad weights of >50, 10–50, 5–10, 2–5, and <2 g in the ICIQ-SF total, Q1, Q2, and Q3 scores 12 months postoperatively. (B) In the laparoscopic sacrocolpopexy (LSC) group, box plots show a significant relationship between pad weights of 10–50, 2–5, and <2 g in the ICIQ-SF total and Q3 scores. Box plots also showed a significant relationship between pad weights of 10–50 and <2 g in the ICIQ-SF Q1 and Q2 scores 12 months postoperatively. (C) In the by transvaginal mesh surgery (TVM) group, box plots showed a significant relationship between pad weights of >50, 10–50, 5–10, 2–5, and <2 g in the ICIQ-SF total Q1, Q2, and Q3 scores 12 months postoperatively. ICIQ-SF, International Consultation on Incontinence Questionnaire Short Form; POM, postoperative month. *P<0.05, significantly different (all).
Spearman rank correlation coefficient also showed a significant correlation between the ICIQ-SF and the pad test in all patients, LSC and TVM groups, preoperatively and 12 months postoperatively (all P<0.001).
DISCUSSION
In the present study, we found a significant relationship between ICIQ-SF total and component question scores and 1-hour pad weight in all patients preoperatively (Fig. 1A). The significant association between ICIQ-SF total and component question scores and 1-hour pad weight was generally similar before LSC and TVM (Fig. 1B and C). At 12 months postoperatively, the ICIQ total scores in all patients significantly declined as the 1-hour pad weight decreased (Fig. 2A). In the LSC group, the ICIQ-SF total and component question scores tended to decrease as the pad weight decreased, but the differences were not always significant between ICIQ scores and pad weight (Fig. 2B). In the TVM group, the ICIQ-SF total and component question scores also significantly decreased as the pad weight decreased (Fig. 2C). To show that the significant association between the 1-hour pad test and the ICIQ-SF score, we decided to present several graphs before and after the surgery.
The pad test is used to measure the degree of UI and evaluate the treatment response of patients [18]. It can be performed in 1 hour in the office with particular exercises, or 1–3 days at home with regular activities. UI has been categorized as mild, moderate, or severe based on pad test severity [19]. Whether the pad test helps forecast the treatment course is unclear.
The ICIQ-SF, a patient self-reported tool with benefits and drawbacks, is an example of how questionnaires provide validity, reliability, and responsiveness to change [9,15]. It has been used in clinical trials and observational research [20] and validated against the 24-hour pad test and more intrusive urodynamic examinations after radical prostatectomy, wherein UI is one of the major postoperative complications [21-23]. The International Prostate Symptom Score and the overactive bladder symptom score are also questionnaires for measuring the degree of UI but are designed to assess the presence and degree of UUI and were not included in the results of this study.
We usually apply the 1-hour pad weight testing to assess the extent of SUI because it is considered to more likely reflect the degree of SUI than 24-hour pad weight testing. However, patients with POP are generally elderly and often have difficulty performing the 1-hour pad weight testing. Some reports recommended not to use the pad test as a standard method of evaluating UI [24,25]. In certain cases, remote medical facilities do not conduct the pad test. Because time and body movement can affect the results, an appropriate pad test depends on established practices. We investigated a significant correlation between the degree of 1-hour pad weight and ICIQ-SF scores to use the ICIQ-SF as a substitute for the 1-hour pad weight testing. Thus, most ICIQ-SF scores were significantly decreased as the pad weight decreased. Another study also examined the association and level of agreement between ICIQ-SF scores and the number of pads used in 24 hours to determine UI after radical prostatectomy, and they concluded that pad use was significantly associated with ICIQ-SF score at 12 months after radical prostatectomy, although the frequency of continence varied depending on the criteria [14]. We considered that a 24-hour pad test might be suitable for elderly patients who do not have the level of activities of daily living required for the 1-hour pad test; however, we also speculated that the ICIQ-SF would be a better substitute.
UI is a complication that commonly occurs after POP surgery [6]. Simultaneous incontinence surgery can decrease the incidence of postoperative SUI and enhance QoL [6,26]. However, no method has been accepted for forecasting the incidence of postoperative SUI. Consequently, because of its dubious necessity, possible risks, and cost, doctors continue to struggle with whether to perform concurrent incontinence surgery [26]. To prevent overtreatment, the choice should be based on the results of adequate preoperative evaluation. In addition, the foundation of preoperative decision-making should be precise based on individual risk prediction. Some studies suggested that BMI, age, and TVM were predictors for SUI [27-29]. TVM may result in postoperative SUI because of neuronal denervation, urethral supporting abnormalities, and overcorrection of the bladder neck [30-32]. Based on our previous study, the occurrence rate of SUI was higher in the TVM group than in the LSC group. However, we already made a new stencil paper for TVM to reduce the occurrence of postoperative SUI. Our new technique in the previous report could prevent too much mesh tension on the bladder neck [33].
This study has several limitations. First, it was a retrospective study using a limited sample size. A larger, multicenter prospective study could reinforce the generalizability of the results and provide more definitive evidence on the utility of the ICIQ-SF. Moreover, increasing the number of cases in future studies will improve the statistical power and the robustness of the findings. Second, the median follow-up duration following surgery was short. Nonetheless, patients with benign conditions, such as POP, should be observed for >3 months postoperatively. Notwithstanding, extended follow-up periods beyond the 12 months currently studied could offer insights into the longterm reliability and validity of the ICIQ-SF in assessing SUI severity after POP surgery. Third, the LSC group has a slightly less significant correlation between pad weight and ICIQ score than the TVM group. This may be attributed to the smaller number of patients in the LSC group than in the TVM group. However, our findings indicated a correlation between pad weight caused by UI and ICIQ-SF total and component question scores.
In conclusion, the ICIQ-SF could be an appropriate substitute for the 1-hour pad weight testing in predicting the severity of UI to some extent. In the future, we hope to predict the level of urine leakage from the ICIQ-SF score.
Notes
Grant/Fund Support
This study received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Research Ethics
The study protocol was approved by the institutional ethics committee (ID 4219) of National Defense Medical College, (ID 4219), and all patients provided written informed consent forms.
Conflict of Interest
No potential conflict of interest relevant to this article was reported.
AUTHOR CONTRIBUTION STATEMENT
· Conceptualization: KKuroda, KH, KI
· Data curation: KKuroda, KH, KKawamura, AM, HK, AH
· Formal analysis: KKuroda, KH, KKawamura, AM, HK, AH, KI
· Methodology: KKuroda, KH, KKawamura, AM, HK, AH, KI
· Project administration AM, HK, AH, KI
· Writing - original draft: KKuroda
· Writing - review & editing: KH, KKawamura, AM, HK, AH, KI