Should sacrouterine plication be added to lateral suspension surgery? A prospective study

Laparoscopic lateral suspension is a novel approach for repairing anterior and apical pelvic organ prolapse (POP). According to integral theory, urinary symptoms and pelvic pain are believed to originate from suspensory ligaments. We aimed to investigate the objective and subjective outcomes of adding sacroterine plication to apical prolapse surgery.


INTRODUCTION
Pelvic organ prolapse (POP) is a significant pathology affecting the quality of life in women, with a prevalence of up to 40%. 1 The lifetime risk for POP surgery is reported to be 12.6%, and the annual risk is 4.3 per 1000 women. 2 In some cases, the grade of prolapse is associated with symptoms such as urinary dysfunction, a sensation of vaginal bulging, sexual dysfunction, constipation, or chronic back pain, leading to a decrease in quality of life.However, in certain cases, the grade may not align with these symptoms, and life quality may not be significantly affected, as expected. 3Various surgical approaches should be planned based on factors such as the patient's age, POP stage, and the anatomical compartment where the defect is present (e.g., cystocele, rectocele, enterocele, uterine prolapse, and post-hysterectomy vaginal vault prolapse).Previous surgeries, comorbid conditions, the patient's personal expectations, and even sexual considerations should be taken into account. 4acrocolpopexy is the current gold standard in the treatment of apical prolapse, but it can become surgically complicated, especially in the advanced age group, due to comorbidities or patient-related factors, such as obesity and anatomical variations.Furthermore, minimally invasive sacrocolpopexy requires surgical expertise and is associated with a higher perioperative complication risk compared to vaginal surgery. 5There is a strong association between apical prolapse and defects in the anterior vaginal wall.Especially in cases where the endopelvic fascia is detached from the apex of the cervix, apical support should generally accompany anterior prolapse repair. 6In recent years, the lateral suspension described by Dubisson in POP surgery has contributed to the repair of apical defects and the simultaneous correction of anterior prolapse. 7However, based on integral theory, shortening and reinforcing uterosacral ligaments have been proven to reduce overactive bladder symptoms, nocturia, and frequent urination symptoms in pelvic organ prolapse. 8e aimed to investigate whether adding sacrouterine plication to the surgical procedure for patients with existing prolapse should be included as routine practice.In line with this hypothesis, our goal is to compare the postoperative objective and subjective surgical outcomes of patients undergoing laparoscopic lateral suspension and sacrouterine plication with those undergoing only lateral suspension reconstruction.

METHODS
We included 60 patients with Grade 2 or higher symptomatic apical POP who visited our hospital between 2021 and 2022.Patients who preferred other POP surgical techniques or pessaries, those who had undergone hysterectomy, and patients with suspected gynecological malignancy or premalignant lesions were excluded from the study.

Preoperative assessment
The preoperative assessment of the patients included transvaginal and perineal ultrasound, physical examination, demographic data collection, and a standard evaluation incorporating the Pelvic Organ Prolapse Quantification (POP-Q) scale.Stress urinary incontinence (SUI) was diagnosed by clinical examination, which included the cough-stress test in the supine and standing positions with a 300-mL saline-filled bladder and changes over 30 in the Q-tip test after a maximum Valsalva maneuver and cough.The clinician assessed the severity of existing nocturia, dyspareunia, and constipation using a non-validated Likert-type scale (0 -3).Nocturia was scored as follows: 0 = no episodes, 1 = one episode, 2 = two to three episodes, and 3 = four or more episodes.
Validated versions of the Pelvic Organ Prolapse Symptom Score (POP-SS), PISQ-12 questionnaire, and Urogenital Distress Inventory-6 (UDI-6) were used to assess subjective improvements (preoperative, postoperative 6-12th months).The POP-SS was used to evaluate the severity of the prolapse symptoms.The POP-SS includes seven questions with scores from 0 to 28.Higher scores are indicative of more bothersome symptoms. 9he Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire was used to evaluate sexual function in the trial.PISQ-12 is a validated, objective, and self-administered questionnaire used for evaluating sexual function based on 12 questions, which identifies three distinct and separate domains of sexual function: behavioral emotive domain (Questions 1-4), physical domain (Questions 5-9), and partner-related domain (Questions 10-12).The scores were calculated by totaling the scores for each question with 0 = never and 4 = always.Reverse scoring was used for Questions 1-4.The total score (0-48) for a specific participant was used to evaluate her sexual function, with a lower score indicating better sexual function. 10UDI-6 is a short version of a condition-specific quality-of-life instrument, UDI, which was introduced in 1994. 11Presently, due to its feasibility, UDI-6 is used much more often than its longer version.The UDI-6 level of validation according to ICI grades is A. 12 The instrument consists of 6 items: 1-frequent urination, 2-leakage related to feeling of urgency, 3-leakage related to activity, 4-coughing, or sneezing small amounts of leakage (drops), 5-difficulty emptying the bladder, and 6pain or discomfort in the lower abdominal or genital area.Higher scores on UDI-6 indicate a higher disability.The total score ranges from 0 to 100.The Patient Global Impression of Improvement (PGI-I) questionnaire was used at the last postoperative visit to evaluate the patients' postoperative improvement.The PGI-I questionnaire is a 7-point Likert scale that enables clinicians to evaluate the extent of improvement or deterioration in a patient's condition relative to a baseline state established at the onset of treatment, using the following rates: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. 13Complications of surgery were assessed using the Clavien-Dindo classification. 14

Postoperative evaluation
Systematic postoperative clinical and symptomatic evaluation was conducted at 6 months and 1 year by an independent urogynecologist who was not involved in the surgical group.The primary outcome measures included anatomical and subjective cures, assessed during the last follow-up visit.Anatomical cure was defined separately for the apical and anterior compartments, with POP-Q scores for sites C and Ba less than À1 cm, respectively.The subjective cure was defined as the absence of bulge symptoms, with the patient answering "Never" to Question 1 (A feeling of something coming down from or in your vagina?) of the POP-SS scale.Secondary outcome measures included scores from the POP-SS, UDI-6, and PISQ-12.Patient satisfaction was assessed using the PGI-I at the last follow-up and considered satisfactory when the PGI-I was answered with "much better" or "very much better." Hysteropexy was the initial choice for women with descensus and no other organic gynecological problems.Patients who underwent only lateral suspension were categorized as Group 1, while those who underwent lateral suspension and sacrouterine plication were categorized as Group 2. Patients requiring additional surgical interventions were informed preoperatively (myomectomy, prophylactic salpingectomy, etc.).In all cases, titanium-coated macroporous polypropylene mesh was used.All surgeries were performed by the same surgical team.

Surgical procedure: Lateral suspension
After placing a 10-mm supraumbilical port, two 5-mm lateral ports were inserted 3 cm above each anterior superior iliac spine.On the right side, an additional 5 mm port was placed.A V-shaped polypropylene mesh, 20 cm in length with a 4-Â 4-cm base, was prepared, and using a 10-mm trocar, it was inserted into the abdominal cavity.With dissection of the vesicouterine peritoneum, the cervicovaginal fascia was exposed.The V-mesh was then placed and secured on the anterior part of the cervix using a delayed absorbable tacker device (Absorba Tack™ Covidien, Mansfield, MA, USA).The mesh was tacked to the cervix six times.Additionally, the base of the mesh in the isthmus uteri region was fixed with intracorporeal sutures (2-0 prolene) (Figure 1).Adequate fixation was achieved by spreading the anterior strip of the mesh.Subsequently, the trocars were removed from the modified port sites, and using graspers, the mesh was advanced through the subperitoneal tunnel, reaching the cervical area beneath the round ligament.The arms of the mesh were pulled symmetrically through the tunnels until the external cervical ostium was suspended just above the level of the ischial spine.The vesicouterine peritoneum was closed with 2-0 Vicryl sutures (Figure 2).The bilateral ends of the mesh were cut at the skin level, leaving both lateral suspensions tension-free.

Sacrouterine plication
Following the lateral suspension procedure, anteriorsuperior traction was applied to the uterus, and bilateral uterosacral ligaments were identified posteriorly to the cervix.The bilateral ureteral courses were observed transperitoneally, and sacrouterine ligaments were plicated in a helical fashion at 0.5 cm intervals with non-absorbable ethibond sutures covering one-third of the total length.Bilateral ureters were checked for kinking and obstruction (Figure 3).
The study, based on the work conducted by Yassa and colleagues, determined a sample size of 30 for each group, with an 80% confidence interval and a 5% margin of error ( 2).
This single-center, prospective study received ethical approval from the Prof.Dr. Cemil Tascıoglu City Hospital Ethics Committee with approval number 77 on May 04, 2022.Every participant granted their informed approval.This study was performed in line with the principles of the Declaration of Helsinki.
F I G U R E 1 Fixing the mesh to the pubocervicovaginal fascia with the help of an absorbable tacker.

Statistical analysis
The descriptive statistics for continuous data included mean, standard deviation, median, and 25th-75th percentiles (IQR).For categorical data, the number and percentage values were provided.The normality of the data distribution was assessed using the Shapiro-Wilk test.The Mann-Whitney U test was employed to compare continuous data and scale scores between the two groups.Chi-square and Fisher's exact tests were used for group comparisons of nominal variables (in cross-tabulations).The Friedman test was utilized for comparing scale scores across preoperative, postoperative 6 months, and postoperative 1 year.In cases where differences were found, the Friedman multiple comparison test was used to determine the specific time points contributing to the differences.IBM SPSS for Windows 20.0 (SPSS Inc., Chicago, IL) was used for data analysis, and a significance level of p <0.05 was accepted.

RESULTS
There were no significant differences in the demographic data of the patients.In Group 1, one patient showed a 7cm hematoma in the superiolateral part of the pubocervicovaginal fascia postoperatively.Observation of this patient revealed spontaneous resolution of the hematoma one week later, requiring no additional intervention.In Group 1, another patient exhibited postoperative sterile pyuria, which resolved with antibiotic therapy.In Group 2, during the sacrouterine plication procedure, ureteral kinking was observed in two patients during the operation; sutures were released, and ureter dissection was performed retroperitoneally between the broad ligament and the infundibulopelvic ligament in these patients.No major postoperative complications were observed in any patient (Clavien-Dindo grade ≥3a).
During postoperative follow-ups, a de novo overactive bladder was seen in four patients in Group 1 and three patients in Group 2. Patients were initially recommended for behavioral therapy (lifestyle changes and bladder training) following ICS guidelines.Significant improvements in symptoms were observed, and in two individuals with persistent symptoms, short-term (3 months) antimuscarinic therapy resulted in complete symptom resolution.Both groups showed improvements in nocturia symptoms at the postoperative 1-year mark, especially in the group that underwent sacrouterine plication, where nocturia scores were lower (p = 0.021).There were no significant changes in the postoperative scores for dyspareunia or constipation.The findings are summarized in Table 1.

Primary outcome
During postoperative follow-ups, patients in both groups showed improvement, particularly in apical and anterior prolapses.Anatomic cure for apical prolapse and anterior prolapse was observed at 100% and 70%, respectively, in Group 1 ( p < 0.001).In Group 2, the rates were 100% and 73.3% for apical and anterior prolapse, respectively (p < 0.001).However, there was no improvement in the posterior compartments and anatomical Bp points (p = 0.312, p: 0.258).In total, two patients, one from each group, underwent colpography at 6 months postoperatively due to symptomatic cystocele and rectocele.The findings are summarized in Table 2.
Out of 60 patients, 58 answered "Never" to the question "A feeling of something coming down from or in your vagina?" indicating the absence of bulge symptoms.The subjective cure was 96.6%, and there was no significant difference between the groups.

Secondary outcomes
Significant improvements were observed in the POP-Q, UDI-6, and PISQ-12 scores of patients in both Group 1 and Group 2 ( p <0.001).In Group 2, which underwent sacrouterine plication, the improvements in scores at the 1-year mark were greater than those in Group 1 (p <0.001).The patient satisfaction rates were 100% (PGI-I ≥2) for both groups.The findings are summarized in Table 3.

DISCUSSION
In this study, we observed the success of the laparoscopic lateral suspension technique, which has been frequently applied in recent years for apical prolapse reconstruction.The reduction of anterior prolapse in addition to apical restoration is considered an additional advantage provided by the surgical technique.Petros's integral theory paradigm aligns well with ICS definitions.According to this paradigm, bladder symptoms are thought to arise not from the bladder itself but primarily from damage to the suspensory ligaments and/or fascia.In parallel with this paradigm, strengthening the uterosacral ligaments has been suggested to reduce symptoms such as urgency, frequency, and nocturia and to alleviate chronic pelvic pain in women. 15Studies suggest that laparoscopic lateral suspension mimics the cardinal ligament, supporting the apical compartment.Further, the plication of the sacrouterine ligament, performed in line with the theory in this study, surgically shortened the existing uterosacral ligaments, thereby reinforcing the ligaments.In particular, the group that underwent sacrouterine plication showed significant improvements in nocturia symptoms.Both groups of patients in our study showed significant improvements in urinary function and sexual life during the one-year follow-up period.However, the improvements in scores were more pronounced in the group that underwent sacrouterine plication.Some previous studies added mesh placement to apical repair and lateral suspension in the rectovaginal space in the treatment of apical and posterior compartment defects.However, this may increase the risk of posterior mesh erosion. 16Furthermore, lateral suspension does not provide a solution for posterior prolapse, and there is a persistent hypothesis that when applied to patients without high rectocele, lateral suspension of the apex may facilitate the later development of enterocele or descent of the upper part of the rectum. 17Recent Cochrane reviews have shown that vaginal repair is considered a alternative and a practical treatment for posterior compartment defects. 18In our study, no significant changes were observed in the posterior compartments in either group.However, regarding symptomatic rectocele or enterocele-like posterior compartment defects, we share the same opinion in favor of vaginal repair.
Laparoscopic lateral suspension is perfectly suitable for preserving the uterus, which is a crucial factor for many women, in line with the requirements of the era.Moreover, avoiding hysterectomy speeds up the procedure and limits potential complication risks. 19Consistent with this idea, in a lateral suspension surgical series involving 417 patients in the first year, the anatomical success rate was found to be 93.6% for the apical compartment 91.6% for the anterior compartment, and the subjective cure rate was 78.4%.Furthermore, more than 85% of patients evaluated their conditions as improved, and they reported that this satisfaction was associated with the absence of a simultaneous hysterectomy. 20In another series with a smaller patient cohort, a study involving 39 patients in the lateral suspension surgical series showed an anatomical success rate of 82% at a 13.5-month follow-up. 4Similarly, in another study with a 17.5-month follow-up, an anatomical success rate of 82.2% and a new recurrence rate of 8.2% in the first year postoperatively were observed. 21Overall, our surgical results are comparable to the literature, with a 100% anatomical cure rate for apical prolapse and a 96.6% subjective cure rate.
Alternative surgical methods to the gold standard sacrocolpopexy are increasingly emerging in the restoration of apical prolapse. 22Superior hypogastric plexus lesions and spondylodiscitis sacral fixation are wellknown complications of sacrocolpopexy, with numerous cases described in the literature. 23The advantages of lateral suspension, particularly in preventing complications related to promontory dissection in obese women, are evident.Our sacrouterine plication procedure extends the duration of the existing lateral suspension procedure, particularly due to increased bleeding during dissectionrelated adhesions from previous surgeries.In terms of surgical duration, Groups 1 and 2 had durations of 65 and 115 min, respectively.In the literature, similar to our study, uterine-preserving lateral suspension surgery was reported to last an average of 117 min, and post-hysterectomy vaginal suspension lasted an average of 193 min. 24This can be considered an additional advantage of uterine-preserving surgery.Another advantage of lateral suspension is undoubtedly the addition of sacrouterine plication, which we believe will reduce the frequency of SUI by bringing the vaginal axis to the dorsal axis.According to data from studies, the middle and lower parts of the urethra adhere to the anterior vaginal wall, providing a stable "backing plate" for the middle and lower parts of the urethra.The pubococcygeal muscle contracts to support the anterior vaginal wall and compress the posterior urethral wall, effectively maintaining urethral closure pressure and playing a role in urinary control when abdominal pressure increases. 25This actually supports the hypothesis we stated at the beginning of our study.In recent years, pectopexy surgery, which is frequently performed, is actually one of the alternative new methods to sacrocolpopexy, but there is no study comparing pectopexy surgery with lateral suspension in terms of apical prolapse surgery in the literature.New methods are receiving more attention today due to the difficult anatomy and experience required in minimally invasive surgery for sacrocolpopexy.Furthermore, the pectopexy procedure is being adopted as a novel technique in clinical settings due to its short learning curve and minimal operative complications.In a study by Coson et al., it was discovered that the strength of the iliopubic ligament surpasses that of the sacrospinous ligament, allowing the mesh to be sutured and anchored to the iliopubic ligament. 26Another recent study compared "laparoscopic high uterosacral ligament suspension with hysterectomy" (LHUSLS) and pectopexy groups for treating apical prolapse.The study revealed that laparoscopic pectopexy is more effective than "LHUSLS with hysterectomy" specifically in correcting apical prolapse. 27hus, while the use of mesh in lateral suspension may favor pectopexy, whether sacrouterine plication should routinely be added to pectopexy will be clarified through future research endeavors.
Studies have reported mesh exposure rates of 4.3%-5.5% after laparoscopic lateral suspension. 28Mesh complications were not observed in our 1-year follow-up; however, the short 1-year follow-up period for mesh surgery is one of the limitations of our study.Other limitations include a small patient cohort and the inclusion of only patients with preserved uteri.The evaluation of patients by urogynecologists, independent of the surgical team, strengthened our study.The application of the same surgical team and surgical procedures technically prevented potential bias.The increasing trend in minimally invasive surgery in recent years, along with multicenter studies with larger cohorts, will enable us to better analyze the results.

F
I G U R E 2 Closing the vesicouterine peritoneum.F I G U R E 3 Sacrouterine plication procedure.

T A B L E 1
Demographic and surgical data of Group 1 and Group 2 patients.Group 1 (n = 30) Group 2 (n = 30) Comparison of preoperative, postoperative sixth month, and postoperative first year scale scores in Group 1 and Group 2 patients within and between groups.
T A B L E 3 a Mann-Whitney U test.b Friedman test.