RU2843884C1 - Method of treating vaginal prolapsed accompanied by isolated cystocele - Google Patents

Abstract

FIELD: medical science.

SUBSTANCE: invention refers to medicine, namely to surgical gynaecology. Two-staged treatment of vaginal prolapsed accompanied by cystocele is carried out. Surgical stage and a stage of paraurethral introduction of the hyaluronic acid filler. First stage involves a straight longitudinal incision along an anterior vaginal wall under general anaesthesia with underlying suprafascial and subfascial tissue hydrodissection. Performing the subfascial space dissection from the vaginal walls in the lateral directions from the incision, separating the Halban pubic-cervical fascia, existing fascial defect is verified and eliminated by suturing a fascia by separate vicryl U-sutures. Then performing the medial portion of Halban fascia contralateral displacement until the defect is closed and plicated by applying separate U-sutures from vicryl, thus forming the Halban fascia double plication, excess mucosa of posterior vaginal wall is resected not more than 5 mm from incision edge, followed by restoring the anatomical integrity of the vaginal mucosa. At the second stage, the preparation of hyaluronic acid in amount of 1 ml on all vectors is introduced into a paraurethral region in the lateral and from below the external urethral opening along three vectors – on the III, IX and VI o’clock of the clock face into soft tissues. After the introduction of the preparation, the contours of a paraurethral region are palpated.

EFFECT: method enables reducing intraoperative injuries, probability of recurrence and urinary incontinence, as well as improving the functional therapeutic effect.

3 cl, 2 dwg, 1 tbl, 2 ex

Description

Field of technology

The invention relates to the field of medicine, namely to surgical gynecology, and can be used for reconstructive plastic surgery in women with prolapse of the anterior vaginal wall, accompanied by cystocele.

State of the art

A recent systematic review of articles on the epidemiology of pelvic organ prolapse (POP) found that prevalence varies widely (1–65%) depending on whether its presence is confirmed by symptoms (1–31%), perineological examination (10–50%), or both (20–65%) [1–3]. Anterior vaginal wall prolapse (AVWP), also known as cystocele, is one of the common forms of POP that significantly impacts women’s quality of life [4, 5]. Despite its significant impact on health, treatment of AVP remains challenging due to the high recurrence rate after surgery.

Surgical correction is the mainstay of treatment for symptomatic OP, but recurrence rates are significant [6, 7]. The use of synthetic mesh in surgical correction reduces recurrence rates compared with native tissue repair but is associated with an increased risk of infection [8, 9]. Furthermore, perioperative vaginal estrogen has not improved surgical success rates [4]. Factors influencing morbidity and recurrence include age, parity, body mass index, genetic predisposition, and history of gynecologic surgery [10–12]. These factors must be considered when choosing a treatment strategy for each patient.

Thus, there is a need to develop new methods of surgical treatment of OPV aimed at reducing the frequency of relapses and improving the quality of life of patients.

A method of surgical treatment of cystocele is known, which includes an incision and separation of the vaginal mucosa from the external opening of the urethra to the external os of the cervix, isolation of the urinary bladder with the urethra with exposure of the urogenital diaphragm, dissection of the vesicouterine ligaments, suturing of the diaphragm tissue with the capture of the posterior wall of the urinary bladder to the right and left of the urethra with separate stitches, resection of the vaginal wall and suturing of the wound with a Reverdin suture (RU2012129632 A, 2014.01.20).

The disadvantages of this method are:

• Lack of clear visualization and correction of fascial defects, which can lead to recurrence of cystocele.

• Traumatic nature of the method associated with extensive tissue dissection and dissection of the ligamentous apparatus.

• Risk of developing postoperative complications such as hematomas, infections, and urinary disorders.

• Lack of additional urethral support, which may not provide optimal functional results, especially in patients with concomitant mild urinary incontinence.

• Insufficient assessment of the long-term anatomical and functional results of this method.

A method is known for surgical reconstruction of the vesicovaginal septum in case of prolapse and prolapse of the anterior vaginal wall and cystocele, which includes suturing the urethrovesical segment, the bottom of the bladder and the vesicovaginal fascia, applying a purse-string suture to the overstretched posterior wall and bottom of the bladder with simultaneous movement of the bottom of the bladder to the area of the urovesical sphincter, installation and fixation of a mesh made of titanium nickelide thread between the reconstructed posterior wall of the urethra, the bladder and the vesicovaginal fascia (RU Patent No. 2262314, 2004.03.01).

The disadvantages of this method are:

• Use of synthetic material (titanium nickelide mesh), which can lead to the development of erosions, infectious complications, pain syndrome and dyspareunia in the postoperative period.

• Complexity of the technique of installing and modeling the mesh, which requires high qualifications of the surgeon and increases the duration of the operation.

• Insufficient correction of fascial defects, since the main emphasis is on the installation of a mesh implant, and not on the restoration of the patient’s own tissues.

• Lack of additional support for the middle third of the urethra, which may not provide optimal functional results in patients with concomitant mild urinary incontinence.

• Insufficient assessment of long-term anatomical and functional results, as well as the quality of life of patients after this operation.

A method for surgical correction of uterine prolapse and anterior vaginal wall (cystocele) by vaginal access is known, including anterior colporrhaphy by transverse access, separation of the vaginal walls to the internal obturator muscle and iliac spine on both sides, isolation of the sacrospinous ligaments on both sides (RU Patent 2688433, 2017.12.11). An implant made of titanium "silk" is used, the anterior central part of which is fixed to the vaginal wall in the area of the border with the neck of the bladder with two sutures at 11 and 13 o'clock, and the lower edge is fixed to the cervix with two sutures at 5 and 7 o'clock.

The disadvantages of this method are:

• Use of synthetic material (titanium “silk” implant), which can lead to the development of erosions, infectious complications, pain syndrome and dyspareunia in the postoperative period, despite the reduction in the risk of these complications stated in the patent.

• Complexity of the technique of installation and fixation of the implant, requiring highly qualified surgeons, special instruments (Serapro) and increasing the duration of the operation.

• Insufficient correction of fascial defects, since the main emphasis is on the installation of a mesh implant, and not on the restoration of the patient’s own tissues.

• Risk of developing pain syndrome and urination disorders due to tension of the implant and its fixation to the sacrospinal ligaments and obturator muscle.

• Lack of additional support for the middle third of the urethra, which may not provide optimal functional results in patients with concomitant mild urinary incontinence.

The technical problem solved by the claimed invention is the need to overcome the shortcomings inherent in analogues and the prototype by creating a method of surgical treatment of cystocele with a low recurrence rate and high functional results.

Disclosure of invention

The technical result of the claimed method consists in reducing the trauma of the operation, confirmed by a decrease in the PFDI-20 indicator, characterizing distress from pelvic floor dysfunction, by 3.6 times when using the claimed method compared to 1.2 times when using classical methods one year after treatment (p < 0.001); a decrease in the severity of urinary incontinence symptoms, confirmed by a decrease in the PFIQ-7 indicator, reflecting the impact of pelvic floor dysfunction on quality of life, by 6.1 times when using the claimed method compared to 1.5 times when using classical methods one year after treatment (p < 0.001); improved functional results confirmed by a 2.9-fold decrease in the ICIQ-SF score assessing the severity of urinary incontinence symptoms when using the claimed method compared to 1.3-fold when using classical methods one year after treatment (p < 0.001) and a 5.2-fold decrease in the recurrence rate of cystocele (31.2 versus 6.0%, p < 0.001). Thus, the proposed method provides a statistically significant improvement in the measured parameters (PFDI-20, PFIQ-7, ICIQ-SF) characterizing a decrease in the trauma of the operation, a decrease in the likelihood of recurrence and severity of urinary incontinence symptoms, as well as an improvement in functional results compared to classical methods.

The specified technical result is achieved by a method for treating vaginal prolapse accompanied by cystocele, which includes two stages: a surgical stage and a stage of paraurethral injection of a filler based on hyaluronic acid, wherein

The surgical stage includes:

performing under general anesthesia against the background of suprafascial and subfascial tissue hydrodissection with 0.9% NaCl2 solution - 20.0 ml + lidocaine 1%-2.0 of a longitudinal straight incision along the anterior vaginal wall. Then, a methodical wide dissection of the subfascial space from the vaginal walls in lateral directions from the incision is performed in order to isolate the anatomy of the pubocervical fascia of Galban. After intraoperative verification of the fascial defect, it is eliminated by applying U-shaped vicryl sutures. Then, a contralateral displacement of the medial portion of the fascia is performed until the defect is completely closed and its plication is also performed by applying at least two separate U-shaped vicryl sutures (the interval for each step is 2-3 mm), thus forming a double plication of the Galban fascia. After incomplete resection of excess mucous of the anterior vaginal wall no more than 5 mm from the edge of the longitudinal incision, it is sutured with a continuous suture. Layer-by-layer restoration of the anatomical integrity of the vaginal mucosa is performed. Hemostasis control was carried out based on visual assessment of signs of bleeding and hematoma formation.

The stage of paraurethral injection of a hyaluronic acid filler includes:

the needle is inserted laterally and from below the external opening of the urethra in the longitudinal direction into the paraurethral region along three soft tissue vectors at III, IX and VI o'clock positions on the conventional clock face. A preparation based on high-molecular sodium hyaluronate 21 mg/ml is injected linearly-retrograde along the lateral vectors in a volume of 0.3 ml, and from below in a volume of 0.4 ml, a total of 1 ml for all vectors, the introduction is performed slowly (one injection for at least 2 minutes) with constant hemostasis monitoring, after the implant is inserted, the contours of the paraurethral region are modeled by palpation, the patient's condition is monitored throughout the procedure, and the absence of bleeding is monitored. Hemostasis was monitored based on a visual assessment of signs of bleeding and hematoma formation.

Performing suprafascial and subfascial tissue hydrodissection reduces the risk of injury to the urethra, bladder and blood vessels, as well as reduces tissue bleeding.

Double plication reduces the likelihood of recurrence and the severity of urinary incontinence, as well as improves functional results.

The proposed method for treating anterior vaginal wall prolapse accompanied by cystocele includes double plication of the Galban fascia to strengthen the supporting structures and eliminate the fascial defect, as well as paraurethral injection of hyaluronic acid-based volume-forming gels (sodium hyaluronate 21 mg/ml) for additional urethral support and improved functional results. The combination of these methods allows for optimal anatomical correction and improved quality of life in patients with anterior prolapse.

High molecular weight sodium hyaluronate 21 mg/ml (for example, DELIGHT® G) can be used as a hyaluronic acid-based preparation.

Brief description of the drawings.

The invention is illustrated by the following illustrative material.

Fig. 1 shows a schematic representation of the stages of the operation (A-G): wide dissection of the subfascial space from the vaginal walls in lateral directions from the incision in order to isolate the anatomy of the Galban pubocervical fascia; U-shaped sutures to eliminate the fascial defect, second plication of the fascia with U-shaped sutures, suturing of the mucosa.

Fig. 2 shows a schematic representation of the stage of paraurethral injection of a hyaluronic acid-based filler. Black lines indicate the vectors of injection of high-molecular sodium hyaluronate 21 mg/ml into the paraurethral region laterally and below the external opening of the urethra: at 9 and 6 o'clock on the conventional clock face. 0.3 ml of the preparation is injected linearly-retrograde along the lateral vector at 9 o'clock, a similar injection of 0.3 ml is performed along the lateral vector at 3 o'clock (not shown in the figure). 0.4 ml of the filler is injected along the lower vector at 6 o'clock.

Implementation of the invention

The method of treating vaginal prolapse accompanied by cystocele includes two stages: a surgical stage and a stage of paraurethral injection of a hyaluronic acid-based filler.

At the first, surgical stage:

Under general anesthesia, against the background of suprafascial and subfascial tissue hydrodissection with 0.9% NaCl2 solution - 20.0 ml + lidocaine 1%-2.0, a longitudinal straight incision is made along the anterior wall of the vagina. Then, a methodical wide dissection of the subfascial space is performed from the vaginal walls in lateral directions [13] from the incision in order to isolate the anatomy of the pubocervical fascia of Galban. After intraoperative verification of the fascial defect, it is eliminated by applying U-shaped vicryl sutures. Then, a contralateral displacement of the medial portion of the fascia is performed until the defect is completely closed and its plication is also performed by applying at least two separate U-shaped vicryl sutures (the interval for each step is 2-3 mm), thus forming a double plication of the Galban fascia. After incomplete resection of excess mucous of the anterior vaginal wall no more than 5 mm from the edge of the longitudinal incision, it is sutured with a continuous suture. Layer-by-layer restoration of the anatomical integrity of the vaginal mucosa is performed [13]. Hemostasis control was performed based on visual assessment of signs of bleeding and hematoma formation.

Stage of paraurethral injection of hyaluronic acid filler:

At the second stage, a needle is inserted laterally and below the external urethral opening in the longitudinal direction into the paraurethral region along three soft tissue vectors at III, IX and VI o'clock positions on the conventional clock face. A preparation based on high-molecular sodium hyaluronate 21 mg/ml is injected linearly-retrograde along the lateral vectors in a volume of 0.3 ml, and from below in a volume of 0.4 ml, a total of 1 ml for all vectors, the introduction is performed slowly (one injection for at least 2 minutes) with constant hemostasis monitoring, after the implant is inserted, the contours of the paraurethral region are modeled by palpation, the patient's condition is monitored throughout the procedure, and the absence of bleeding is monitored. Hemostasis was monitored based on a visual assessment of signs of bleeding and hematoma formation.

According to the conducted study, the developed method of surgical treatment of vaginal prolapse accompanied by cystocele is characterized by technical simplicity, good anatomical effect and low frequency of adverse events in the early and late postoperative periods, low frequency of relapses and high functional results.

The present study included 98 women aged 34 to 44 years (mean age 40.6±3 years) with a clinically verified diagnosis of pelvic floor muscle failure, prolapse of the anterior vaginal wall with cystocele formation (ICD10 codes - N81.1). All patients had a detailed medical history, complaints were assessed, and a comprehensive perineological examination was performed. The severity of urinary incontinence was assessed using the ICIQ-SF questionnaire. The PFDI-20 and PFIQ-7 questionnaires were used to determine the number of symptoms and their frequency over time.

The patients were randomly assigned to one of two equal groups: group I (according to the declared method, the essence of which is anterior colporrhaphy with double plication of Galbanum in combination with paraurethral administration of volume-forming gels based on hyaluronic acid, n=50) and group II (standard anterior colporrhaphy, n=48).

The operation by the claimed method was performed on patients of group I. A distinctive feature of this method is suprafascial and subfascial tissue hydrodissection, which helps to reduce the risk of injury to the bladder, urethra and blood vessels and reduce tissue bleeding, double plication of the fascia by applying two rows of U-shaped sutures and contralateral displacement of the medial leaflet to correct the fascia defect, a longitudinal incision on the mucosa and the absence of excessive excision of the vaginal mucosa, as well as paraurethral administration of a filler based on high-molecular sodium hyaluronate 21 mg / ml in a volume of 1 ml along three vectors at III, VI and IX o'clock on the conventional dial, which helps to reduce the likelihood of relapses and the severity of urinary incontinence, as well as improve functional results.

In group II, patients underwent standard anterior colporrhaphy with excision of the vaginal wall with an oval flap, mobilization of the bladder and application of a purse-string suture.

Early and late postoperative complications were not observed in both study groups. The frequency of recurrence of vaginal wall prolapse with cystocele formation in Group II was observed in 10 patients (20.8%) after a year, and in 15 patients (31.2%) after 2 years. The frequency of recurrences in Group I was 4% after a year after the intervention, 6.0% after 2 years.

Thus, the proposed, developed and implemented new method for treating vaginal prolapse accompanied by isolated cystocele is characterized by technical simplicity and a good anatomical effect (a 5.2-fold reduction in the recurrence rate of cystocele, 31.2 versus 6.0%, p<0.001).

When comparing the results between the groups before treatment, no statistically significant differences were found in the PFDI-20 (p = 0.554), PFIQ-7 (p = 0.383) and ICIQ-SF (p = 0.958) indices, indicating that the initial state of the patients in both groups was comparable. However, one year after the operation, statistically significant differences were found between the groups in all three indices (p < 0.001). The patients in Group I, who underwent the operation using the claimed method, demonstrated a more pronounced improvement compared to the patients in Group II, who underwent standard anterior colporrhaphy with perineolevatorplasty. The average values of the indicators one year after the operation in Group I were 3.1 times lower for PFDI-20 (15.58 vs 47.75), 4.0 times lower for PFIQ-7 (3.42 vs 13.69) and 2.2 times lower for ICIQ-SF (2.04 vs 4.46) compared to Group II. The treatment results are shown in Table 1.

Table 1. Postoperative improvement of symptoms in patients of both groups.

Group Indicator Before treatment In a year p Group I (n=50) PFDI-20 (M±SD (95% CI) 56.34 ± 5.79 (54.69 - 57.99) 15.58 ± 6.90 (13.62 - 17.54) < 0.001* Group II (n=48) PFDI-20 (M±SD (95% CI) 55.67 ± 5.41 (54.10 - 57.24) 47.75 ± 4.50 (46.44 - 49.06) < 0.001* p (between groups) PFDI-20 0.554 < 0.001* - Group I (n=50) PFIQ-7 (M±SD (95% CI) 20.76 ± 5.25 (19.27 - 22.25) 3.42 ± 1.74 (2.93 - 3.91) < 0.001* Group II (n=48) PFIQ-7 (M±SD (95% CI) 19.88 ± 4.72 (18.50 - 21.25) 13.69 ± 3.59 (12.65 - 14.73) < 0.001* p (between groups) PFIQ-7 0.383 < 0.001* - Group I (n=50) ICIQ-SF (M±SD (95% CI) 5.98 ± 1.91 (5.44 - 6.52) 2.04 ± 0.81 (1.81 - 2.27) < 0.001* Group II (n=48) ICIQ-SF (M±SD (95% CI) 5.96 ± 2.14 (5.34 - 6.58) 4.46 ± 1.75 (3.95 - 4.97) < 0.001* p (between groups) ICIQ-SF 0.958 < 0.001* - * - differences in indicators are statistically significant (p < 0.05)

The obtained data indicate that the proposed method of surgical treatment of isolated cystocele, including double plication of the Galban fascia in combination with paraurethral administration of hyaluronic acid-based volume-forming gels, provides significantly better results in terms of improving the symptoms of pelvic organ prolapse, quality of life and urinary incontinence compared with the standard technique of anterior colporrhaphy, which is confirmed by multiple differences in the average values of the indicators one year after surgery.

Clinical example 1.

Patient B., 45 years old, with a history of 3 vaginal births, has been suffering from prolapse of the anterior vaginal wall, accompanied by cystocele, for 6 years. She complained of frequent urination, a feeling of incomplete emptying of the bladder, and discomfort in the vagina.

St. localis: The external genitalia are developed correctly, according to the female type. When straining, the genital slit gapes, the anterior wall of the vagina protrudes 4 cm from the introitus vaginae. Signs of a grade III cystocele have been established.

The patient underwent surgery according to the stated method. The course of the surgery:

Under general anesthesia, against the background of suprafascial and subfascial tissue hydrodissection with 0.9% NaCl2 solution - 20.0 ml + lidocaine 1%-2.0, a longitudinal straight incision was made along the anterior vaginal wall. Methodical wide dissection of the subfascial space from the vaginal walls in lateral directions from the incision was performed in order to isolate the anatomy of Galban's fascia. After intraoperative verification of the fascial defect, it was eliminated by applying 4 separate U-shaped vicryl sutures. Contralateral displacement of the medial portion of the fascia and its double plication were performed by applying 3 separate U-shaped sutures. Incomplete resection of excess mucous membrane of the anterior vaginal wall was performed at a distance of 3 mm from the edge of the longitudinal incision. Layer-by-layer restoration of the anatomical integrity of the vaginal mucosa was performed.

The second stage involved paraurethral injection of a filler based on high-molecular sodium hyaluronate 21 mg/ml (DELIGHT® G) in a volume of 1 ml along three vectors at III, VI and IX o'clock on the conventional clock face for 6 minutes (each injection for at least 2 minutes). After the injection, the contours of the paraurethral region were modeled. The patient's condition was monitored and hemostasis was controlled.

Total blood loss: 70.0 ml.

Urine released by catheter - light, 200 ml

In the postoperative period, she was activated from the first day. She received a single antibacterial therapy and symptomatic treatment. The postoperative period is uneventful. The sutures on the mucous membrane are in satisfactory condition, without edema and hematomas, urination is independent, painless, the wound heals by primary intention. She was discharged in satisfactory condition for further outpatient observation by a doctor at the women's clinic (polyclinic) at her place of residence.

A follow-up examination of the patient was performed after 3 months. The condition was satisfactory. No complaints. The genital slit was closed, the vaginal walls were intact when straining, the vagina was passable for 2 transverse fingers, a dense painless postoperative scar was palpated along the anterior wall of the vagina. Urination was free and painless.

A follow-up examination of the patient was performed after 1 year. The condition was satisfactory. No complaints. When straining, the genital slit did not gape, the vagina was passable for 2 transverse fingers, a dense painless postoperative scar was palpated along the anterior wall of the vagina. Urinary incontinence and a feeling of incomplete emptying of the bladder were not noted. According to the questionnaires using the PFDI-20, PFIQ-7 and ICIQ-SF questionnaires, a significant improvement in the quality of life and a decrease in the severity of symptoms compared to the preoperative level were noted.

Clinical example 2.

Patient V., 52 years old, with a history of 2 vaginal births and 1 cesarean section, has been suffering from prolapse of the anterior vaginal wall, accompanied by cystocele, for 8 years. She complained of difficulty urinating, a feeling of incomplete emptying of the bladder, and discomfort in the vagina.

St. localis: The external genitalia are developed correctly, according to the female type. When straining, the genital slit gapes, the anterior wall of the vagina protrudes 5 cm from the introitus vaginae. Signs of a grade IV cystocele have been established.

The patient underwent surgery according to the stated method. The course of the surgery:

Under general anesthesia, against the background of suprafascial and subfascial tissue hydrodissection with 0.9% NaCl2 solution - 20.0 ml + lidocaine 1%-2.0, a longitudinal straight incision was made along the anterior vaginal wall. Methodical wide dissection of the subfascial space from the vaginal walls in lateral directions from the incision was performed in order to isolate the anatomy of Galban's fascia. After intraoperative verification of multiple fascial defects, they were eliminated by applying separate 3 U-shaped vicryl sutures. Contralateral displacement of the medial portion of the fascia and its double plication were performed by applying 3 separate U-shaped sutures. Incomplete resection of excess mucous membrane of the anterior vaginal wall was performed at a distance of 3 mm from the edge of the longitudinal incision. Layer-by-layer restoration of the anatomical integrity of the vaginal mucosa was performed.

The second stage involved paraurethral injection of a filler based on high-molecular sodium hyaluronate 21 mg/ml (DELIGHT® G) in a volume of 1 ml along three vectors at III, VI and IX o'clock on the conventional clock face for 7 minutes (one injection for at least 2 minutes). After the injection, the contours of the paraurethral region were modeled. The patient's condition was monitored and hemostasis was controlled.

Total blood loss: 90.0 ml.

Urine released by catheter - light, 250 ml

In the postoperative period, she was activated from the second day. She received a course of antibacterial therapy and symptomatic treatment. The postoperative period was uneventful. The sutures on the mucous membrane are in satisfactory condition, without edema and hematomas, urination is independent, painless, the wound heals by primary intention. She was discharged in satisfactory condition for further outpatient observation by a doctor at the women's clinic (polyclinic) at her place of residence.

The patient was examined 6 months later. Her condition was satisfactory. No complaints. The genital slit was closed, the vaginal walls were intact when straining, the vagina was passable for 2 transverse fingers, a dense painless postoperative scar was palpated along the anterior vaginal wall. Urination was free, painless, no episodes of urinary incontinence were noted.

A follow-up examination of the patient was performed after 1.5 years. The condition was satisfactory. No complaints. The genital slit did not gape during straining, the vagina was passable for 2 transverse fingers, a dense painless postoperative scar was palpated along the anterior wall of the vagina. Urinary incontinence and a feeling of incomplete emptying of the bladder were not noted. According to the questionnaire data using the PFDI-20, PFIQ-7 and ICIQ-SF questionnaires, a significant improvement in the quality of life and a decrease in the severity of symptoms compared to the preoperative level were noted. The patient noted an increase in sexual activity and satisfaction due to the elimination of anatomical and functional disorders.

Bibliography:

1. Orazov M. R., Toktar L. R., Lologaeva M. S., et al. Modern methods of treating pelvic organ prolapse: anterior and posterior compartment // Obstetrics and Gynecology: News. Opinions. Training. 2021.

2. Zuchelo LTS, Bezerra IMP, Da Silva ATM, et al. Questionnaires to evaluate pelvic floor dysfunction in the postpartum period: a systematic review. Int J Womens Health . 2018;10:409-24. DOI:10.2147/IJWH.S164266

3. Gong R, Xia Z. Collagen changes in pelvic support tissues in women with pelvic organ prolapse. Eur J Obstet Gynecol Reprod Biol . 2019;234:185-9. DOI:10.1016/j.ejogrb.2019.01.012

4. Rahn DD, Richter HE, Sung VW, Pruszynski JE, Hynan LS. Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial. JAMA. 2023 Aug 15;330(7):615-625. doi: 10.1001/jama.2023.12317. PMID: 37581673; PMCID: PMC10427941.

5. Lang P, Whiteside JL. Anterior compartment prolapse: what's new? Curr Opin Obstet Gynecol. 2017 Oct;29(5):337-342. doi: 10.1097/GCO.0000000000000392. PMID: 28759459.

6. Kastelein AW, Diedrich CM, de Waal L, Ince C, Roovers JWR. The vaginal microcirculation after prolapse surgery. Neurourol Urodyn. 2020 Jan;39(1):331-338. doi: 10.1002/nau.24203. Epub 2019 Nov 5. PMID: 31691336; PMCID: PMC7004127.

7. So JB, Palmer MT, Shellito PC. Postoperative perineal hernia. Dis Colon Rectum. 1997 Aug;40(8):954-7. doi: 10.1007/BF02051204. PMID: 9269813.

8. Notten KJB, Vergeldt TFM, van Kuijk SMJ, Weemhoff M, Roovers JWR. Diagnostic Accuracy and Clinical Implications of Translabial Ultrasound for the Assessment of Levator Ani Defects and Levator Ani Biometry in Women With Pelvic Organ Prolapse: A Systematic Review. Female Pelvic Med Reconstr Surg. 2017 Nov/Dec;23(6):420-428. doi: 10.1097/SPV.0000000000000402. PMID: 28134704.

9. Kohli N, Sze EH, Roat TW, Karram MM. Incidence of recurrent cystocele after anterior colporrhaphy with and without concomitant transvaginal needle suspension. Am J Obstet Gynecol. 1996 Dec;175(6):1476-80; discussion 1480-2. doi: 10.1016/s0002-9378(96)70093-5. PMID: 8987928.

10. Häggström C, Hagberg O, Gårdmark T, Aljabery F, Ströck V, Hosseini A, Sherif A, Malmström PU, Söderkvist K, Ullén A, Jerlström T, Jahnson S, Liedberg F, Holmberg L. Cohort profile: Bladder Cancer Data Base Sweden (BladderBaSe) 2.0. BMJ Open. 2022 Dec 20;12(12):e064898. doi: 10.1136/bmjopen-2022-064898. PMID: 36600418; PMCID: PMC9772662.

11. Feng D, Wang Z, Yang Y, Li D, Wei W, Li L. Incidence and risk factors of parastomal hernia after radical cystectomy and ileal conduit diversion: a systematic review and meta-analysis. Transl Cancer Res. 2021 Mar;10(3):1389-1398. doi: 10.21037/tcr-20-3349. PMID: 35116464; PMCID: PMC8798402.

12. Guyomard A, Delorme E. Transvaginal treatment of anterior or central urogenital prolapse using six tension-free straps and light mesh. Int J Gynaecol Obstet. 2016 Jun;133(3):365-9. doi: 10.1016/j.ijgo.2015.10.016. Epub 2016 Feb 16. PMID: 26971260.

13. Amin K, Lee U. Surgery for Anterior Compartment Vaginal Prolapse: Suture-Based Repair. Urol Clin North Am. 2019 Feb;46(1):61-70. doi: 10.1016/j.ucl.2018.08.008. PMID: 30466703.

Claims (3)

1. A method for treating vaginal prolapse accompanied by cystocele, which includes two stages: a surgical stage and a stage of paraurethral injection of a hyaluronic acid-based filler, wherein at the first stage, under general anesthesia against the background of suprafascial and subfascial hydrodissection of tissues, a longitudinal straight incision is made along the anterior wall of the vagina, the subfascial space is dissected from the vaginal walls in lateral directions from the incision, the pubocervical fascia of Galban is isolated, the existing fascial defect is verified and its elimination is performed, for which the fascia is sutured with separate U-shaped vicryl sutures, then a contralateral displacement of the medial portion of the Galban fascia is performed until the defect is closed and it is plicated by applying separate U-shaped vicryl sutures, thus forming a double plication of the Galban fascia, resection of the excess mucous membrane of the posterior the vaginal walls are no more than 5 mm from the edge of the incision, after which the anatomical integrity of the vaginal mucosa is restored; at the second stage, laterally and from below in relation to the external opening of the urethra, a preparation based on hyaluronic acid is introduced into the paraurethral region along three vectors - at III, IX and VI o'clock on the conventional clock face into the soft tissues in a volume of 1 ml for all vectors, after the introduction of the preparation, the contours of the paraurethral region are modeled by palpation. 2. The method according to paragraph 1, characterized in that the administration of the drug is performed with constant monitoring of hemostasis. 3. The method according to item 1, characterized in that the method is carried out with constant monitoring of the patient’s condition and control of the absence of bleeding.