The recurrence rate of conventional procedures for severe pelvic organ prolapses (POP) is high, with the anterior vaginal wall being the most common site of recurrence, with 60% of prolapses recurring at the initial site and approximately 1/3 requiring reoperation. Since patients with severe POP often have defects in their own tissues, clinicians are increasingly resorting to synthetic materials to reinforce the supporting tissues of the pelvic floor as a way to improve the outcome of pelvic floor reconstruction. Reconstructive pelvic surgery (RPS) with transvaginal polypropylene mesh is one of the main procedures used in these patients. It is well known that patients with severe POP have different degrees of pelvic floor dysfunction (PFD), which can have a serious impact on their quality of life, and the relief of PFD symptoms and improvement of quality of life are one of the important clinical criteria to measure the success of such surgery. Whether transvaginal polypropylene mesh pelvic floor reconstruction surgery is effective in relieving PFD symptoms and improving patients’ quality of life while enhancing pelvic floor support is a common concern for both doctors and patients. In this regard, the Department of Obstetrics and Gynecology of the First Affiliated Hospital of the PLA General Hospital conducted a prospective study of PFD symptoms and quality of life in patients who underwent transvaginal polypropylene mesh RPS for severe POP between May 2004 and March 2011, and is reported below.
1 Data and methods
1.1 Study population
A total of 114 patients with severe POP were treated with polypropylene mesh RPS at our hospital from May 2004 to March 2011. 114 patients had a mean age of (64±8) years, a mean body mass index (BMI) of (24.6±2.7) kg/m2 , a mean number of deliveries (2.8±1.5), a mean time to menopause (14±8) years, and no history of sex hormone therapy. Of the 114 patients, 65 (57%) had more than one medical comorbidity, including 47 cases of hypertension, 11 cases of coronary artery disease and postoperative cardiac disease, 17 cases of diabetes mellitus, 4 cases of cerebrovascular disease, 9 cases of chronic bronchitis, 2 cases of chronic obstructive pulmonary disease, and 1 case of non-Hodgkin’s lymphoma with systemic lupus erythematosus. 114 patients were staged in stages III-IV according to the POP quantitative grading (POP-Q) method, of which 84 (74%) were in stage III. All 114 patients were staged from stage III to stage IV according to the POP-Q method, including 84 cases (74%) in stage III and 30 cases (26%) in stage IV. There were 6 cases of recurrence after simple repair of the anterior and posterior vaginal walls and 5 cases of fornix prolapse after hysterectomy. The objective criterion for successful surgery was POP-Q stage ≤ stage I. Stage I was considered as failure or recurrence.
1.2 Methods
1.2.1 Questionnaire
The classic international questionnaire for evaluating PFD symptoms and their impact on quality of life in the field of female PFD research was used: the Pelvic Floor Distress Inventory short form PFDI-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire short form PFIQ-7 (pelvic floor The PFDI-20 consists of 20 POP symptom questions and includes 3 subscales: pelvic organ prolapse distress inventory (POPDI-6), colorectal distress inventory (POPDI-6), and pelvic floor impact questionnaire (PFIQ-7) [1]. The PFDI-20 scale consists of three subscales: pelvic organ prolapse distress inventory (POPDI-6), colorectal-anal distress inventory (CRADI-8), and urinary distress inventory (UDI-6). The score of PFDI-20 is 0 for no symptoms, 1 for no effect on quality of life, 2 for mild effect, 3 for moderate effect and 4 for severe effect. The score of each question of the subscale was summed ÷ the corresponding number of questions × 25 as the subscale score, and the score range was 0 to 100. The total scale score is the sum of the 3 subscale scores, ranging from 0 to 300. The PFIQ-7 is also divided into three scales: pelvic organ prolapse impact questionnaire (POPIQ-7); colorectal-anal impact questionnaire (CRAIQ-7); and pelvic prolapse impact questionnaire (CRAIQ-7). (CRAIQ-7); and urinary impact questionnaire (UIQ-7). Each scale consists of 7 questions related to daily life, which are used to evaluate the impact of PFD symptoms on quality of life. Scoring criteria: no impact on quality of life 0, mild impact 1, moderate impact 2, severe impact 3. The score of each question of the subscale was summed up ÷ the number of corresponding questions × 100 ÷ 3 as the subscale score, which ranged from 0 to 100. The sum of the 3 subscale scores was the total scale score, which ranged from 0 to 300. The higher the score, the greater the impact of PFD symptoms on patients’ quality of life.
1.2.2 Questionnaire implementation method
The questionnaire was administered exclusively by non-surgical staff and completed with the patient. The preoperative questionnaire was completed before the surgery was performed after admission, and the postoperative questionnaire was completed at the 2-month, 6-month, and 1-year postoperative outpatient follow-up visits. All patients who completed the questionnaires were conscious and could answer the questions independently.
1.3 Statistical methods
SPSS 10.0 software was used for statistical analysis. t-test or rank sum test was used for quantitative data, Pearson c2 test was used for categorical data, and P < 0.05 was considered as statistically significant difference.
2 Results
2.1 Surgical situation
Transvaginal polypropylene mesh RPS was performed in 114 patients, including 97 (85.1%) anterior pelvic polypropylene mesh RPS and 17 (14.9%) total pelvic polypropylene mesh RPS. Intraoperative transvaginal hysterectomy was also performed in 102 cases (89.5%), high sacral ligament vaginal suspension in 95 cases (83.3%), tension-free urethral sling suspension in 44 cases (38.6%), perineal body and anal levator suture in 95 cases (83.3%), cystoscopy in 95 cases (83.3%), external anal sphincter repair in 1 case, and abdominal wall hernia repair in 1 case. The mean operative time was (180±52) min (90-405 min), and the mean bleeding was (248±142) ml (50-800 ml). The bladder was damaged by intraoperative needle puncture in 2 cases, which healed spontaneously after 1 week of indwelling urinary catheter. In another case, a hematoma of about 6 cm in diameter on the left side of the bladder was found by ultrasound examination due to persistent postoperative lower abdominal pain, which improved after hemostasis and local physiotherapy, and the hematoma disappeared by ultrasound on outpatient review 2 months after surgery. There were 3 cases of urinary tract infection, 1 case of pulmonary infection with type II respiratory failure and 1 case of perineal body infection within one week after surgery, all of which were cured after anti-infection treatment, with a postoperative disease rate of 4.4% (5/114).
2.2 General postoperative follow-up
The follow-up rates were 84% (96/114), 75% (85/114) and 68% (77/114) at 2 months, 6 months and 1 year postoperatively, respectively. The POP-Q stage was ≤ stage I in all follow-ups up to 1 year postoperatively, and the objective success rate of surgery was 100%. Vaginal mesh exposure was found in a total of 19 cases (19.8%, 19/96) with a mean diameter of (0.64±0.55) cm (0.1-2 cm) at 2 months postoperatively; 13 cases (15.3%, 13/85) with a mean diameter of (0.40±0.30 cm) (0.1-1 cm) at 6 months postoperatively; and 6 cases (7.8%, 6/77) at 1 year postoperatively. 7.8%, 6/77) with a mean diameter (0.43±0.26 cm) (0.1 to 1 cm); 6 cases ( 7.8%, 6/77) were found to have mesh exposure at 1 year postoperatively. The management of mesh exposure was based on the method recommended by Muffly and Barber, which included regular observation, topical estrogen ointment and metronidazole suppositories, and outpatient or inpatient cutting of exposed mesh [2]. Most exposures were treated by this method and gradually improved and healed, with no case progressing. One patient was hospitalized 11 months after surgery to have the exposed mesh removed because she did not want to tolerate long-term abnormal vaginal discharge, and a review 2 months after surgery showed that the exposed area had healed.
2.3 Postoperative follow-up of patients with PFD symptoms and quality of life
Most of the preoperative vaginal or pelvic symptoms, urinary distress symptoms, and bowel obstruction symptoms were significantly relieved at 2 months postoperatively and maintained until 1 year postoperatively; most of the fecal incontinence-related symptoms improved, and none of them worsened (Table 1). Accordingly, postoperative PFDI-20 and PFIQ-7 scores and their subscales were significantly lower than before surgery (Table 2).
Table 1 Distribution of PFD symptoms in patients before and after polypropylene RPS surgery (n, %)
PFD symptoms
Preoperative
(n=114)
2 months postoperatively
(n=96)
6 months postoperatively
(n=85)
12 months postoperatively
(n=77)
Vaginal or pelvic symptoms
Lower abdominal pain
17 (14.9)
10 (10.4)
5 (5.9)
0 (0)*
Pelvic cramping sensation
57 (50)
16 (16.7)*
3 (3.5)*
1 (1.3)*
Feeling of walking friction
44 (38.6)
0 (0)*
0 (0)*
0 (0)*
Sensation of swelling prolapse
107 (93.9)
0(0)*
0 (0)*
0 (0)*
Urinary distress symptoms
Difficulty in urination
51 (44.7)
8 (8.3)*
5 (5.9)*
4 (5.2)*
Feeling of incomplete urination
57 (50)
11 (11.5)*
12 (12.5)*
8 (10.4)*
Stress urinary incontinence
46 (40.4)
17 (17.7)*
12 (12.5)*
10 (13)*
Urge incontinence
26 (22.8)
7 (7.3)*
7 (8.3)*
7 (9.1)**
Hand-assisted urination
23 (20.2)
0 (0)*
0 (0)*
0 (0)*
Frequent urination
37 (32.5)
10 (10.4)*
6 (7.1)*
6 (7.8)*
Urinary urgency
29 (25.4)
9 (9.4)*
7 (8.2)*
6 (7.8)*
Defecation distress symptoms
Urgency of stool
6 (5.3)
1 (1)
1 (1.2)
3 (3.9)
Dry stool incontinence
2 (1.8)
1 (1)
1 (1.2)
1 (1.3)
Scanty stool incontinence
6 (5.3)
2 (2.1)
1 (1.2)
1 (1.3)
Gas incontinence
7 (6.1)
1 (1)
0 (0)
1 (1.3)
Difficulty in defecation
36 (31.6)
14 (14.6)*
5 (5.9)*
8 (10.4)*
Feeling of incomplete bowel movement
27 (23.7)
7 (7.3)*
5 (5.9)*
5 (6.5)*
Hand-assisted defecation
11 (9.6)
0 (0)*
0 (0)**
0 (0)*
Note: Comparison with preoperative: * indicates P < 0.01, ** indicates P < 0.05
Table 2 PFDI-20, PFIQ-7 and subscale scores before and after polypropylene mesh RPS surgery (`x±s )
Questionnaire
Preoperative
(n=114)
2 months after surgery
(n=96)
6 months postoperatively
(n=85)
12 months postoperatively
(n=77)
PFDI-20
62.40±43.70
13.70±7.95*
9.76±14.81*
5.89±12.13*
POPDI-6
29.58±18.37
2.86±5.62*
1.84±4.17*
0.81±2.24*
UDI-6
24.92±21.76
8.21±13.39*
6.85±11.12*
3.41±7.02*
CARDI-8
8.27±12.49
2.54±6.94*
1.10±3.76*
1.66±6.05*
PFIQ-7
79.90±55.81
14.65±5.84*
9.45±21.23*
6.35±18.04*
POPIQ-7
39.81±24.95
3.82±6.83*
3.47±11.88*
1.11±3.70*
UIQ-7
32.01±28.93
8.23±19.15*
5.43±12.65*
3.46±10.41*
CARIQ-7
8.04±20.64
3.08±13.07**
0.55±3.28*
1.72±7.35*
Note: Comparison with preoperative: * indicates P < 0.01, ** indicates P < 0.05
3 Discussion
Compared with sacrovaginal fixation for the treatment of severe POP, transvaginal polypropylene RPS has similar objective efficacy and the advantages of less trauma, less difficulty, faster recovery and lower complications, and has become one of the mainstream procedures for the treatment of severe POP. However, unlike the positive efficacy of sacrovaginal fixation supported by Class I level evidence [3], the efficacy and safety of polypropylene mesh in transvaginal RPS has not been validated in sufficient randomized controlled trials. Complications such as mesh exposure, infection, painful intercourse, organ perforation, and vascular nerve injury have been reported, affecting patients’ quality of life in mild cases and even life threatening in severe cases [4]. However, regardless of the surgical approach, effective relief of PFD symptoms and improvement of quality of life while restoring pelvic floor anatomy remain a common concern for both patients and physicians. The results of this study showed that transvaginal polypropylene mesh RPS effectively relieved most of the PFD symptoms and significantly improved patients’ quality of life, which is similar to the results of concurrent studies in China and abroad [5-9]. Usually, efficacy in clinical studies is judged mainly by whether there is a statistically significant difference in the change of study results, but being statistically significant is not necessarily clinically meaningful in practice. The minimal clinically important difference (MCID) is the minimum threshold used to determine whether a change in efficacy is clinically significant, and a change that meets or exceeds the MCID is considered clinically significant [10]. and PFIQ-7 had MCID scores of 45 and 36, respectively [11]. In the present study, the pre- and post-operative changes of PFDI-20 and PFIQ-7 were 48.7 and 62.3 points, respectively, which were higher than their MCIDs, further demonstrating that polypropylene mesh RPS is indeed effective in relieving PFD symptoms and improving quality of life, which is clinically relevant.
From Table 1, it is easy to find that vaginal or pelvic distress symptoms and urinary distress symptoms are the main PFD symptom groups in this group of patients, with the former being particularly important; this is also indicated by the relatively high scores of PODDI-6, UDI-6 and POPIQ-7 and UIQ-7. The study by Mouritsen et al. on the distribution of PFD symptoms in POP patients also found that vaginal or pelvic mechanical Vaginal or pelvic symptoms, such as vaginal mass prolapse, pelvic swelling, and walking friction, are mainly caused by the mechanical effects of POP. The symptoms of urinary obstruction (dyspareunia, dyspareunia, hand-assisted voiding) and the symptoms of instability of the forced urinary muscles (frequency, urgency, urge incontinence) secondary to urinary obstruction were mostly caused by the small angle of the vesicourethra due to the severe bulging of the anterior vaginal wall. The significant postoperative relief of these PFD symptoms in our patients is apparently closely related to the effective restoration of pelvic floor anatomy by transvaginal polypropylene mesh RPS. Feiner et al. reviewed 30 studies of 2653 cases of transvaginal polypropylene mesh RPS with a mean follow-up of 3 to 30 months and showed that the objective success rate of this procedure was 87% to 95% [13]. The present study also showed that none of the cases had POP-Q stage > stage I at 1 year after surgery and the objective success rate was 100%, which is slightly higher than the results of foreign literature. The reasons for this analysis may be as follows: 1) the small number of cases and the still short follow-up period; 2) the high percentage of high sacral ligament vaginal stump suspensions (83.3%). The enhancement of apical vaginal support may further synergize the effect of polypropylene mesh on the anterior vaginal wall support, thus reducing the POP recurrence rate.