Results of surgical treatment of urinary incontinence in women with pelvic organ prolapse

Introduction

Currently, women's demands for a high quality of life are growing, which motivates them to seek timely diagnosis and treatment of pelvic organ prolapse (POP) and urinary incontinence (UI). This problem worries not only urologists but also obstetricians and gynecologists. Therefore, specialized societies have been organized around the world including the ICS (International Continence Society), IUGA (International Urogynecological Association), and many other communities that take on the responsibility of organizing assistance to women with POP and UI [1]. The incidence of POP ranges from 2.9 to 53%, and 47% of them accrue to women of working age [2]. According to the epidemiological data presented by the ICS, UI is widespread in the United States and European countries, where 34 to 38% of women suffer from this disease. In developed countries, the number of those patients amounts to about 30%, while in Russia, this indicator is no more than 10%. In addition, UI and POP are conditions with negative dynamics. On average, 4 to 11% of new cases of the disease emerge every year. Nevertheless, the number of people seeking help in Russia is low. This fact is stipulated by many reasons including the lack of awareness of patients and outpatient doctors, the lack of information, the intimacy of the problem, and the attitude of patients toward this problem as a natural process of aging^{1 2 3}.

Risk factors for POP involve genetic predisposition, vaginal delivery, connective tissue dysplasia, high body mass index, smoking, increased intra-abdominal pressure, cough, and estrogen deficiency. Complicated delivery, perineal ruptures, and the birth of large children² increase the risk of developing POP [1]. It should also be remembered that UI is combined with genital prolapse in 75–82% of cases, while 45–50% of patients over 50 years of age have mixed incontinence, when the condition of the tissues is affected by hormonal disorders and various somatic and gynecological diseases. More than 85% of women with UI have had more than 2 births. The average frequency of perineal ruptures during childbirth is 30–40%⁴. In these cases, at accomplishing transvaginal hysterectomy, the patient’s own tissues should be used for urethral plastic surgery. Over the past 150 years, a large number of surgical interventions have been proposed to strengthen the pelvic floor and fix the prolapsed pelvic organs. However, there is a constant search for new methods to optimize surgical intervention for genital prolapse accompanied by incontinence [2,3,4,5]. The wide variety of surgical treatment methods indicates the lack of a unified approach to this issue. The surgical interventions widely used at the present time are far from perfect. A large number of multi-stage, labor-intensive, and complex methods not only do not relieve patients from suffering but in many cases can lead to serious postoperative complications due to the development of significant cicatricial changes in the paravesical zone [5,6]. Concurrently, it is recommended to perform simultaneous correction of POP and UI in patients with both symptoms to increase the treatment efficacy [6,7]. Thus, the development of new effective methods of surgical treatment of UI in women, especially with genital prolapse, is an urgent task of modern gynecology.

The purpose of the study is to assess the long-term results of surgical treatment of mixed UI in women with POP using the Kelly method in our own modification.

Materials and methods

We assessed the efficacy of using the Kelly operation in our modification in combination with the classical technique of vaginal hysterectomy, anterior and posterior colporrhaphy, and levatorplasty in women with a mixed form of UI; the main group (MG) of the study included 95 women. The comparison group (CG) consisted of women of the same population, age, and genital prolapse with incontinence and included 87 patients, who underwent the classical surgery by the Kelly technique^{5 6 7}. Our modification consisted of the following issues: a flap was cut out from the anterior vaginal wall, retreating 1–1.5 cm from the external opening of the urethra to the area where the anterior vaginal fornix transitions to the cervix. After a typically accomplished vaginal hysterectomy, a rectangular purse-string suture was applied in the area of the vesicoureteral segment, the longitudinal line of which was 6 cm, and the transverse line was up to 2 cm. The fascia was captured in the stitch. The remaining part of the urinary bladder was immersed with a circular purse-string suture. The edges of the vaginal mucosa, which have come together, are sutured with interrupted vicryl sutures, picking up the underlying tissue. This method enables to form the urethral keel of the vagina and the return of the main functions of the urinary tract: to retain urine in the bladder and ensure its release to the outside. This method is protected by a patent of the Russian Federation⁸. All women operated in the clinic were aged 48 to 82 years, therefore, to reliably assess the efficacy of the proposed method and exclude the influence of the age factor on the resulting quality of treatment, one of the main selection criteria was age; the studied groups included women aged 52 to 60 years (average age – 57.02 ± 0.54). The selection criteria were also: POP combined with mixed UI, absence of severe extragenital and oncological diseases, as well as absence of decubital ulcers on the tissues of prolapsed organs. In addition to the general clinical study conducted in accordance with existing recommendations², we used special methods to identify and evaluate incontinence⁹. The degree of POP, as well as the function and strength of the pelvic floor muscles in the examined patients, were assessed according to the classification by Baden and Walker² [7,8]. Information on the quality of life of patients was assessed by the PFDI-20 questionnaire, using the UDI-6 subscale, which correlates well with the main one and can be used to assess surgical treatment of UI¹⁰ [9]. The follow-up period when we assessed the results of the method was on average 3 years after the operation.

The statistical significance of differences in the frequency of occurrence of signs in the groups before and after the operation was assessed using the Pearson chi-square criterion. Differences between the groups were considered significant at a significance level of p < 0.05. Taking into account the overall size of the totality of coverage and its components, we calculated the extensive coefficient in terms of the POP degree to determine the statistical significance of the efficacy of the operation.

Results

All the examined women had a history of pregnancies, which ended in childbirth and abortions (Table 1). Childbirth by cesarean section was an exclusion criterion. The high parity in the studied groups was related to the high frequency of medical abortions amounting to 64 (67.4%) and 63 (72.4%) in the MG and CG, respectively. Most patients gave birth through the natural birth canal twice (53.7% and 55.2%, respectively). Considering that a significant factor in the development of POP is the birth trauma of the mother, we analyzed this indicator. It turned out that grade 1–2 perineal rupture was revealed in 24 (25.2%) patients of the MG and 20 (22.9%) of the CG, which exceeded the average statistical data in the population by 2 times (10–12%), a similar trend was found in terms of grade 3–4 perineal trauma (6.4% and 4.6% in the MG and CG groups, respectively) against the population level of 0.2–1.8%¹¹. Currently, the frequency of operative vaginal deliveries in the world varies from 2.1% to 19.2%. The frequency of obstetric forceps is about 1.1% of the total number of deliveries through the natural birth canal. There is a wide range of using obstetric forceps both by geographic regions and within them, from 0.1% to 6.3%. Vacuum extraction is used much more often and it amounts to about 4.5%. In the Russian Federation, the frequency of vacuum extraction of the fetus is 1.23%, and for obstetric forceps, the indicator value is 0.05%¹². Overall, according to our data, vaginal deliveries using instruments were performed in 15 (8.24%) patients, obstetric forceps were used in 6 (3.29%) patients, and vacuum extraction of the fetus in 9 (4.95%) women in both groups. Considering that operative vaginal deliveries are complicated by vaginal rupture in 10–20% of cases, grade 3–4 perineal rupture in 1.4–8%, and often by urinary and fecal incontinence¹², it should be assumed that these manipulations were predictors of POP and UI in the examined patients.

All women were postmenopausal; the average age at menopause was 47±1.7 years in the MG and 46±1.5 in the CG. The calculation of statistical indicators in Table 1 showed that all differences between the compared groups were statistically insignificant, indicating the congruence of the groups.

The degree of POP was determined according to the classification of Baden and Walker² [8]. Before the operation, POP of grade IV was more often revealed among the examined women both in the MG and in the CG (Table 2). Meanwhile, 3 years after the surgical treatment, only grade II POP was found, and these were patients who had grade III–IV prolapse before the operation. The extensive coefficient in terms of grade II POP before the operation was 8.24%, while after the operation, it was 4.95%; that was 1.7 times less than before the operation and went along with the absence of prolapse of another degree. This indicates that hysterectomy accompanied by vaginoplasty, levatorplasty, and perineoplasty remains a fairly effective method of surgical treatment.

Indications for hysterectomy in cases of POP of degrees II and III of prolapse were the combination of POP with various gynecological pathologies (Table 3).

The severity of POP did not determine the presence and severity of the main clinical symptoms, which bothered patients in both groups of the examined women with comparable frequency (Table 4).

The data in Table 4 attest that POP primarily caused discomfort in the genital area, a sensation of a foreign body in the vagina, and pain (30.52% and 29.89% in the MG and CG, respectively). Sometimes pain and discomfort were felt in the lower abdomen and lumbar area. Episodes of fecal incontinence, gas, and constipation were quite often manifested (28.42% and 28.74%). Concurrently, there was a need to reposition the uterus and apply pressure to the back wall of the vagina to completely empty the rectal ampulla. The most frequent complaints in women of both groups with POP were involuntary urine leakage (55.79% and 55.17%, respectively); weak, intermittent, or splashing stream during urination (33.68% and 32.18%); and difficult urination (53.68% and 52.87%). Many patients had to push back and hold the anterior vaginal wall at pronounced cystocele. Sexually active women reported sexual dysfunction (41.05% and 40.23%). First of all, dissatisfaction with the vaginal tone was expressed by sexual partners; the women themselves indicated a decrease in sensitivity and tone of the vagina during sexual intercourse, as well as dryness of the mucous membrane. Accomplished surgical treatment relieved our patients from many complaints, however, in the CG, some complaints remained, and they were associated with urination. This indicates that the Kelly urethral plastic technique in our modification is effective only in terms of urination. Concurrently, frequent urination and episodes of urgency were noted in 3 (3.16%) patients of the MG, difficult urination was noted in 2 (2.10%) women in 3 years after the operation, while in the CG, problems with urination were noted by 26 (29.89%) patients, which was almost 6 times higher (p < 0.05).

Analyzing the severity of UI (Table 5) before surgery, we found that 53 (55.79%) patients in the MG and 48 (55.17%) patients in the CG did not hold urine. These patients more often manifested moderate UI (58.49% and 60.42%, respectively). Three years after surgery, there were no cases of urinary incontinence in the MG, while in the CG, they were noted by 5 (5.74%) patients. This confirms the effectiveness of the Kelly urethral plastic technique in our modification.

Discussion

Since POP is a disease that does not pose a threat to a woman’s life at a certain stage of monitoring, the main subject of assessing the efficacy of treatment is the impact of its symptoms on the quality of life. The main method for determining the quality of life is a standardized survey with specialized questionnaires. The results of a specific questionnaire in terms of UI symptoms UDI-6 (Urinary Distress Inventory), which is a subscale of PFDI-20 (Pelvic Floor Distress Inventory), are presented in Table 6. The scale is used to determine the number of symptoms and their frequency over time and is a tool for assessing the efficacy of treatment, reflecting the symptoms observed over the past 3 months and their impact on the women’s quality of life. The maximum number of points on this subscale can vary from 0 to 100. Before surgery, the indicators in the examined women did not differ statistically between the two groups (83.3±3.7 and 87.7±2.5, respectively). In 3 years after surgery, women in the MG had no symptoms of UI, while in the CG, patients scored 20.8±0.7, which confirms the efficacy of the surgical treatment.

The conducted functional tests made it possible to reveal that 72 (75.79%) patients of the MG and 42 (48.28%) of the CG had the ability to spontaneously interrupt the act of urination in 3 years after the operation (p<0.05). POP and UI significantly reduce the quality of life, especially in women of working age, and lead to persistent social maladjustment. The identified depressive states in 21 (22.10%) patients of the MG and 22 (25.29%) of the CG, as well as communication disorders (16 (16.84%) and 17 (19.54%)), decreased working capacity (19 (20.0%) and 18 (20.69%)), and chronic fatigue syndrome (23 (24.21%) and 21 (24.14%)), were associated primarily with the disintegration of the entire complex of organs that form the pelvic floor. The conducted studies have shown that the use of the proposed technique in combination with the classical technique of vaginal hysterectomy, anterior and posterior colporrhaphy, and levatorplasty in women with mixed UI improved the outcomes of surgical treatment during the next 3 years of life. First of all, satisfaction with the results of treatment in the first 3 years after surgery was noted by 87 (91.58%) women in the MG and 62 (71.26%) patients in the CG. This fact is very important, since before surgery, 81 (85.26%) patients in the MG and 75 (86.20%) women in the CG had degree IV POP (Table 2), which determined the course of the disease and the low quality of life of the examined women.

Birth trauma, which, according to established data, occurred in 62 (65.26%) patients of the MG and 54 (62.07%) of the CG, was a predisposing factor in the development of genital prolapse. This dictates the need for constant monitoring of careful management of labor and, probably, earlier correction of disorders of the anatomical location of the pelvic organs.

According to clinical guidelines¹¹, episiotomy and perineotomy are not recommended for the prevention of perineal ruptures. Limiting the use of routine episiotomy reduces third- and fourth-degree ruptures. Episiotomy has no short-term or long-term effects in preventing the severity of perineal rupture, dysfunction of the pelvic floor organs, or POP. However, this method of surgical protection of the perineum was used only in 33 (18.13%) patients, which is 3.5 times less than the number of injuries sustained during childbirth (116 (63.73%)). We believe that the timeliness of assessing the risk of perineal rupture during childbirth is important, as are its surgical protection, episiotomy and peritomy technique, and the natural anatomy of tissue recovery.

The positive consequence is the fact that during the surgical treatment, we used the woman’s own tissues from the genital tract, which also promotes preventing various complications and is an economically advantageous method of treatment. It is worth citing the cost of only one UroSling-1 mesh endoprosthesis for surgical reconstruction of the pelvic floor (31,000 rubles) to assess the economic efficiency of accomplished hysterectomy, Kelly urethral plastic surgery, levatorplasty, and colpopyreneoplasty.

To confirm the practical implementation of the proposed method and its high efficacy, examples from clinical practice are presented.

Example 1. Patient L. (MG), 54 years old, came to the clinic complaining of UI during exertion (coughing, sneezing, walking, etc.), prolapse of the vaginal walls and uterus. The postmenopause lasted 4 years, there were 2 births in the anamnesis, the weight of the children was more than 3800 g, during both deliveries there was a perineal rupture. After a complete clinical, laboratory, and instrumental examination, the diagnosis was “Genital prolapse. Incomplete prolapse of the uterus and vagina. Cystocele. Rectocele. Cicatricial deformation and elongation of the cervix. Mixed urinary incontinence”. The planned operation under neuraxial anesthesia was accomplished: vaginal hysterectomy without uterine appendages, anterior and posterior colporrhaphy, urethroplasty in our own modification, and levatorplasty. The course of the operation was typical; blood loss was 120 ml. The course of the postoperative period was uneventful; the patient was discharged on the 5th day in a satisfactory condition. After 2 months, 1 year and 3 years, the patient was examined; the quality of life and the functional state of the bladder were assessed. The pelvic floor was considered competent, with the ability to retain urine in the bladder at rest and under load. The patient was satisfied with the results of the operation; she was able to work and took an active life position.

Example 2. Patient D. (CG), 52 years old, came to the clinic complaining of UI during exertion (coughing, sneezing, walking, etc.), prolapse of the vaginal walls and uterus. The postmenopause lasted 1 year; there was a history of 1 birth; child weight was 4200; vacuum extraction of the fetus, episiotomy, and episiorrhaphy were used. After a complete clinical, laboratory, and instrumental examination, the diagnosis was “Genital prolapse. Incomplete prolapse of the uterus and vagina. Cystocele. Rectocele. Cicatricial deformation of the perineum. Complex urinary incontinence”. The operation was performed under neuraxial anesthesia as planned: vaginal hysterectomy without uterine appendages, anterior and posterior colporrhaphy, urethroplasty using the classical Kelly method, and levatorplasty. The course of the operation was typical; blood loss was 150 ml. The postoperative period was uneventful; the patient was discharged on the 5th day in a satisfactory condition. After 2 months, 1 and 3 years, the patient was examined; a questionnaire was conducted to assess the quality of life, as well as a functional assessment of the bladder was accomplished. The pelvic floor was considered competent, with the ability to retain urine in the bladder at rest and under load over 3 years. In three years after the operation, symptoms of incontinence appeared during prolonged physical exertion but when they were removed, the instability of urination was relieved.

Examples of clinical observations and the results of the analysis of all cases of accomplished operations indicate that the proposed method of surgical treatment of UI in women is more effective than the classical Kelly method. Efficacy is achieved by lengthening the incision to 6 cm and wider tissue separation (up to 2 cm); upon tightening the purse-string vicryl suture, this creates a urethral keel of the vagina, which promotes a longer period of retention of urine in the bladder and timely urination.

Conclusion

The use of the Kelly method in our own modification along with a combination of vaginal hysterectomy, anterior and posterior colporrhaphy, and levatorplasty in women with mixed forms of UI is a pathogenetically justified method for restoring adequate urination, as it reduces the risk of disease relapse and returns the main functions of the urinary tract including retention of urine in the bladder and ensuring its release to the outside that increases the efficacy of surgical treatment and the duration of the positive effect. Conducting surgical treatment of POP and UI improves the quality of life of women, eliminates sexual dysfunction, and normalizes bowel functioning. The results of this study demonstrate the efficacy and validity of the considered method of treating POP and UI using one's own tissues upon vaginal access.