Blackwell Publishing AsiaMelbourne, AustraliaIJUInternational Journal of Urology0919-81722006 Blackwell Publishing Asia Pty LtdApril 2006134389394Original ArticleQuality of life after surgery in cystocele H Matsuyama et al.
International Journal of Urology (2006) 13, 389–394
Original Article
Follow up of surgical repair of female pelvic floor disorders by a mailed questionnaire HIDEYASU MATSUYAMA,1 HIROSHI HIRATA,1 TAKESHI TOMIMATSU,2 GEN-ICHRO YAMAKAWA,3 MASATO TATSUMURA4 AND KATSUSUKE NAITO1 1 Department of Urology, Yamaguchi University School of Medicine, Ube, 2Section of Gynecology, Nagato General Hospital, Nagato, and Sections of 3Urology and 4Gynecology, Yamaguchi Red Cross Hospital, Yamaguchi, Japan Background: This study was conducted to determine whether surgical repair of pelvic prolapse enhances patients’ quality of life (QOL) in the long term. Methods: A total of 91 patients (median age, 68.0 years) with pelvic prolapse including cystoceles underwent bladder neck suspension with anterior/posterior colporrhaphy between 1997 and 2003. Postoperative QOL was longitudinally assessed by three disease-specific items (sensation of vaginal bulging, obstructive symptoms, urinary incontinence), and one overall health-related QOL (HR-QOL) item. Results: A longitudinal study demonstrated that a significant improvement in these symptoms was sustained at a median follow up of 65.5 months, although poor HR-QOL was significantly higher in patients whose age was more than 70 years at surgery (P = 0.0234, Fisher’s test). Multivariate analysis revealed update urinary incontinence, update obstructive symptoms, and basic comorbidity to be independent prognostic factors for predicting postoperative moderate-to-poor HR-QOL. Conclusions: Longer follow up with adequate assessment of patients’ QOL may be crucial for the management of postoperative patients, in particular those having basic comorbidity and aged 70 years or more at surgery. Key words bladder neck suspension, colporrhaphy, cystocele, pelvic prolapse.
Introduction Pelvic prolapse, including cystocele, may be one of the most serious benign disorders hampering the active lifestyle of women because of the sensation of vaginal bulging, urinary incontinence or obstructive symptoms, leading to severe impairment of quality of life (QOL). Although surgical repair of cystocele is one of the most frequently performed gynecourological procedures, the wide variety of surgical techniques used demonstrates how difficult this condition is to manage due to the substantial recurrence rate as well as postoperative complications. Severe cystocele develops because of weakness of the levator sling and pubocervical fascia, resulting in defects of the vesicopelvic fascia either in a central defect, or a lateral one caused by lateral descent of the tendious arc at the attachment of the fascia.1,2 Recent publications have described the advantage of abdominal sacral colpopexy,3 pubovaginal sling using various materials including cadaver allograft fascia,4 autologous fascia3 and synthetic materials.5 However, the overall
Correspondence: Katsusuke Naito MD PhD, Department of Urology, Yamaguchi University School of Medicine, 1-1-1 Minami-Kogushi, Ube 755-8505, Japan. Email:
[email protected] Received 30 April 2005; accepted 18 August 2005.
incidence of synthetic graft erosion into the vagina was reported to be 9% with up to a 35% removal rate.6 Raz et al. reported excellent results of surgical repair by bladder neck suspension (BNS) procedure for moderate cystocele,7,8 while others reported that the BNS procedure yielded a poorer outcome than simple anterior colporrhaphy probably due to destruction of the pubocervical fascia.9 Although a few reports have evaluated patients’ QOL after surgical repair of pelvic prolapse, the follow-up periods have been short, hampering determination of the long-term durability of the procedure.4,10 This study was undertaken to evaluate the long-term efficacy of surgical repair of patients with pelvic prolapse in terms of patients’ postoperative QOL by means of a longitudinal survey with up to a median 65.5 months of follow up. Materials and methods Subjects
A total of 91 patients with pelvic prolapse including cystoceles underwent bladder neck suspension with anterior/ posterior colporrhaphy between 1997 and 2003. Patient demographics were listed in Table 1. The median age and follow-up period were 68.0 years, and 42 months, respectively. Forty-six patients (51%) had urinary incontinence, including mixed, stress, urge and unknown incontinence in
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Table 1 Patient demographics of the study H
Table 2 Complications and basic comorbidities
Number of patients (%) Cystocele Prolapse uteri Rectocele Obstructive symptoms Incontinence Mixed Stress Urge Unknown Basic disease Urodynamic study Cystocele Grade 2 (mild) Grade 3 (moderate) Grade 4 (severe) Mode of operation BNS + VT + A + P BNS + VT + A BNS + A and/or P A+P Age (years) Parity Post-void residual urine (mL) Follow up (months)
91 (100) 79 (87) 71 (78) 49 (54) 46 (51) 15 25 4 2 27 (30) 39 (43) 30 (33) 34 (37) 27 (30) 65 (71) 16 (18) 9 (10) 1 (1) Median (range) 68.0 (37–83) 2.0 (0–7) 44.0 (0–384) 40.4 (4.8–84.6)
A, anterior colporrhaphy; BNS, bladder neck suspension; P, posterior colporrhaphy; VT, transvaginal hysterectomy.
fifteen, twenty-five, four, and two patients, respectively. The cystocele was graded as mild (grade 2), moderate (grade 3), and severe (grade 4) in 30, 34, and 27, respectively, according to the Baden Walker classification system11 (Table 1). The inclusion criteria of the study was to have moderate to severe sensation of vaginal bulging as well as voiding symptoms. Methods
A two-corner bladder neck suspension (BNS) technique with anterior colporrhaphy was applied with the slight modification that anterior colporrhaphy was performed with stringent trimming of the redundant vaginal wall along the line with 1 cm inside of the introitus.7,10 Concomitant prolapse uteri, and rectocele were treated with transvaginal hysterectomy and posterior colporrhaphy by gynecologists, respectively, with standard techniques. De novo instability was clinically diagnosed when urgency or frequency (more than eight times per day) occurred postoperatively. Obstructive symptoms were defined as symptoms including hesitancy, prolonged voiding time, or difficulty to urinate. Postoperative check up comprised chain urethrocystography at 1 week, physical examination, urinalysis, and estimated post-void residual urine by ultrasonography at 3 months, 6 months, and 1 year after operation. The postoperative QOL was assessed in each patient for a maximum of four times by mailing original QOL ques-
Number of patients (%) Complications Blood loss requiring blood transfusion De novo bladder instability Stone formation due to string migration Pulmonary embolism† Ureteral injury Basic comorbidities No Yes Diabetes Mellitus Cerebrovascular disease Hysterectomy Orthopedic spine disorders Cystocele repair operation Neurogenic bladder dysfunction
4 (4.4) 3 (3.3) 1 (1.1) 1 (1.1) 1 (1.1) 64 (70.3) 27 (29.7) 10 3 3 3 2 2
†Relieved by anticoagulant agent.
tionnaires at a median follow up of 12.4, 27.6, 44.5 and 65.5 months after operation (Table 2). The questionnaires consisted of three disease-specific items (sensation of vaginal bulging, obstructive symptoms, urinary incontinence), and one overall health-related QOL (HR-QOL) item (Appendix I). The baseline values were determined by the patient’s recall at first survey. A visual analog scale with score (0–5 points) was applied to each item.10 Two or more scores were arbitrarily classified as having symptoms for disease-specific questionnaires. Overall HR-QOL was classified as good, moderate, and poor for 0–1, 2–3, and 4–5 points, respectively. Evaluation of the representative QOL for each patient was determined by the latest survey from each patient. All patients were encouraged to attend our outpatient clinic and undergo physical examination to check for recurrence of the cystocele. Statistical assessment
To compare the intra- and intergroup differences in the QOL score between baseline and the four surveys, one-way analysis of variance (ANOVA) was applied. Fisher’s exact probability test or χ2-test, and Student’s t-test were applied for categorical and continuous numerical differences, respectively, in univariate analysis. Logistic regression analysis was applied for multivariate analysis. A P-value less than 0.05 was regarded as significant. Results Overview of the study
Sixty-five patients (71%) underwent transvaginal bladder neck suspension, antero-posterior colporrhaphy, and transvaginal hysterectomy. Sixteen patients were treated by transvaginal bladder neck suspension, anterior colporrhaphy, and transvaginal hysterectomy, while nine had transvaginal bladder neck suspension and anterior and/or posterior colporrhaphy (Table 1). The median operating
Quality of life after surgery in cystocele time and estimated blood loss were 202 min and 302 mL, respectively. The mean posterior urethral vesical angle was 99.4 ± 19.3° after surgery. Forty-nine patients (54%) complained of obstructive symptoms (hesitancy, or difficulty to urinate) before operation, 44 (90%) of whom returned to normal voiding, as defined by no complaint of obstructive symptoms and postvoid residual urine below 50 mL. Regarding complications, blood loss requiring blood transfusion and de novo bladder instability were observed in four and three cases, respectively. Additionally, vesical stone formation due to migration of a suspension suture string, postoperative pulmonary embolism that responded to intravenous anticoagulant administration, and ureteral injury caused by a gynecologist during hysterectomy were observed in one case each. Basic comorbidities or predisposition to recurrence were found in 27 (29.7%) cases, notably diabetes mellitus in 10 (37%; Table 2).
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fourth survey, respectively (Table 3). Evaluations of postoperative status for sensation of vaginal bulging, obstructive symptoms, urinary incontinence, and overall HR-QOL were possible in 82 (90%), 81 (89%), 82 (90%), and 82 (90%), respectively. Figure 1 depicts the reply rate of each item of the questionnaires. The average reply rate of the four items was 97.7% ranging from 96.2 to 98.9%. In total, 11 (13.4%) patients complained of sensation of vaginal bulging, 6 (7.3%) of whom were diagnosed with recurrence of cystocele with a median period from operation to recurrence of 43.0 months, ranging from 32.3 to 59.6 months. No obvious recurrence was noted in the other five cases. Obstructive symptoms and urinary incontinence were noted in 8 (9.9%) and 12 (14.6%) cases, respectively. Overall HR-QOL was categorized as good and not good in 64 and 18 (moderate, 14; poor, 4), respectively (Fig. 1). Figure 2 compares the changes in the mean scores of the three disease-specific QOL items and HR-QOL among the baseline, first, second, third and fourth surveys stratified according to the age of 70 years at operation. There was a significant decrease in the scores, representing improvement of the symptom, for all items at all surveys as compared to the baseline in patients whose age was
Quality of life survey
Regarding the QOL questionnaires, 77 (84.6%) of the 91, 43 (79.6%) of the 54, 39 (72.2%) of the 54 and 26 (78.8%) of the 33 patients responded at a median follow up of 12.4, 27.6, 44.5, and 65.5 months at the first, second, third and
Table 3 Results of quality of life survey Survey Number of patients mailed Number of patients responding (%) Median age at survey (years) Median follow-up period (months)
First
Second
Third
Fourth
91 77 (84.6) 70 12.4
54 43 (79.6) 70 27.6
54 39 (72.2) 72 44.5
33 26 (78.8) 73 65.5
100% 80% 98.4%
96.2 %
98.9 %
97.3 %
60% 40% 20% 0% Incomplete Complete
Fig. 1 Reply rate of three diseasespecific and one overall health-related quality of life questionnaire items.
Number of patients evaluated (%) Number of patients symptoms (%)
Vaginal bulging
Obstructive symptoms
Urinary incontinence
Overall HRQOL
3 180
7 176
2 181
5 178
82 (90.1)
81 (89.0)
82 (90.1)
82 (90.1)
11 (13.4)
8 (9.9)
12 (14.6)
18 (22.0)
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H
Below 70 years 70 years or more
Mean Score
5
a) Vaginal Bulging * P < 0.05
4 3 2
*
1
*
0 Baseline (82)
2nd (41)
3rd (40)
4th (25)
b) Obstructive symptoms
5 Mean Score
1st (82)
4 3 2
Discussion
1
Mean Score
0
5
Baseline
1st
2nd
3rd
4th
(81)
(81)
(42)
(37)
(25)
c) Urinary incontinence ** P < 0.01
4 3 2
** **
1 0
Baseline (82)
1st
2nd
3rd
4th
(82)
(43)
(39)
(26)
d) Overall HR-QOL
5 Mean Score
below 70 years (P < 0.0001, vaginal bulging, obstructive symptoms, overall HR-QOL; P = 0.0023, urinary incontinence; ANOVA). Significant decreases were also noted in patients whose age was 70 years or more except for urinary incontinence (P < 0.0001, vaginal bulging, obstructive symptoms, overall HR-QOL; P = 0.5091, urinary incontinence; ANOVA). Improved QOL was sustained in diseasespecific items as well as HR-QOL regardless of the age at the median follow up of 65.5 months. In contrast, evaluation of the representative QOL for each patient demonstrated that poor HR-QOL was significantly higher in patients whose age was more than 70 years (P = 0.0234, Fisher’s test). Multiple logistic regression analysis revealed most recent urinary incontinence, most recent obstructive symptoms, and basic comorbidity to be independent significant prognostic factors for predicting postoperative moderate-to-poor HR-QOL (Table 4). Concerning questions related to satisfaction with the operations, 77% of the patients answered they would be willing either to undergo the same procedure again, and/or to recommend the procedure to their acquaintances.
* P < 0.05
4 3 2
* *
1 0 Baseline
1st
2nd
3rd
4th
(82)
(82)
(41)
(38)
(26)
Fig. 2 Changes in mean score of three disease-specific quality of life items and one health-related quality of life item stratified according to age of 70 years. Figures in parentheses represent cases responded at each survey.
This QOL survey provided the following insights. Surgeons must consider the patient perceived improvement and satisfaction level against a given therapy. Given the lack of literature regarding QOL in this field, we applied our original QOL questionnaires.10 Regarding quantitative validation of the QOL questionnaire, the percentage of the reply rate in each item was almost satisfied as shown in Figure 1. Patients are likely to remember their baseline HR-QOL as being better than it actually was. Such a tendency is more prominent in older patients probably due to age-related increases in physical or emotional disabilities or comorbidities.12 Our results are in good agreement with such data since poor HR-QOL was significantly found in older patients as compared with younger ones. This suggests several possibilities. One is that this surgical repair technique may not be appropriate for elderly patients, since comorbidity had a significant influence on moderate-topoor HR-QOL. Increased physical disability may result in poor HR-QOL in older patients. The other possibility is that our questionnaire regarding HR-QOL was too vague to evaluate the actual overall health-related QOL. One may need careful interpretation of the study from several reasons. The questionnaire is not well-validated. The baseline values were from patient’s recall at first survey. In this case, the baseline data may be biased by the response shift effect, which is defined as a change in the meaning of one’s self-evaluation of QOL as a result of: (i) change in the respondent’s internal standards of measurement (recalibration); (ii) change in the respondent’s value; or (iii) redefinition of life quality (reconceptualization).13,14 For example, patients may feel their QOL should have improved with treatment and therefore they will place worse baseline scores compared to the actual one.14 The response rate of the surveys was not ideal. Well-validated questionnaires with a prospective survey will be needed for the proper evaluation of patients with pelvic prolapse.
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Table 4 Predictive factors for overall health-related quality of life Univariate variables
Category Good (64)
Most recent urinary incontinence Basic comorbidity Most recent obstructive symptoms Sensation of vaginal bulging Age (years) Complication Cystocele Parity Total operation time (min) Bleeding volume (mL) Multivariate variables Most recent urinary incontinence Basic comorbidity Most recent obstructive symptoms
Yes/no Yes/no Yes/no Yes/no
