Sacrospinous Ligament Fixation Research Articles

Obesity and Native Tissue Repairs: A Secondary Analysis of the OPTIMAL Trial.

The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial compared sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) surgical outcomes. Increasing body mass index (BMI) is associated with an increased risk of pelvic organ prolapse, and the prevalence of obesity is increasing worldwide. The purpose of this study was to better understand the effect of obesity on the results of native tissue vaginal apical suspension procedures. This was a secondary analysis of the OPTIMAL Trial data set. Subgroup analysis was performed to compare surgical failure rates between SSLF and ULS across BMI subgroups after 2 years. There were 75, 120, 63, and 39 patients in the normal, overweight, class 1 obesity, and class 2 obesity or greater BMI subgroups, respectively. There were no statistically significant differences in surgical failure rates between SSLF and ULS within BMI subgroups; however, failure rates increased in the ULS group between the nonobese and obese groups (normal, 35.9% SSLF vs 30.6% ULS [P = 0.81]; overweight, 38.6% vs 30.2% [P = 0.44]; class 1 obesity, 38.7% vs 40.6% [P = 0.92]; class 2 obesity or greater, 21.1% vs 45% [P = 0.21]). The risk of surgical failure between SSLF and ULS was not significant across BMI subgroups. Additional investigation is required to further elucidate whether SSLF or ULS is a more reliable option for obese patients.

Effect of two different surgical modalities for pelvic organ prolapse on postoperative wound infection in patients: A meta-analysis.

Sacrospinous ligament fixation (SSLF) is widely applied to the treatment of female pelvis organ prolapsed. Contradictory findings have already been reported in the comparison of sacrocolpopexy (SC) with SSLF. The objective of this study is to evaluate the efficacy of SC versus SSLF in treating pelvis organ prolapsed after operation. We conducted a meta-analysis of both operative approaches, including PubMed, Embase, and Cochrane Library. In this research, 822 articles were chosen from three databases, 201 were copied, and 10 were included. Among them, 7248 cases were operated on the prolapsed pelvis. It was found that SSLF surgery could significantly decrease the rate of postoperative wound infection after operation (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.42-0.82; p = 0.001). No statistical significance was found among the SSLF and the SC surgery for the post-operation haemorrhage of the patient (OR, 0.81; 95% CI, 0.23-2.83; p = 0.75). No statistical significance was found among the SSLF and the SC surgery for the postoperative period of the patient's operation (mean difference, -15.46; 95% CI, -52.87 to 21.94; p = 0.42). Applying SSLF surgery to treat pelvic prolapse in women may benefit from a reduction in the number of post-operative wound infections. However, SSLF had no statistical significance with respect to the amount of haemorrhage after operation or operation time.

The Impact of Preoperative Pain on Outcomes After Vaginal Reconstructive Surgery and Perioperative Pelvic Floor Muscle Training

ABSTRACT In the United States, around 9 million women are affected by pelvic pain due to conditions such as interstitial cystitis/bladder syndrome, fibromyalgia, pelvic floor myalgias, chronic opioid use, or irritable bowel syndrome. Treatment options for concurrent pelvic floor disorders and pelvic pain can prove challenging due to the overall desire to avoid exacerbating overall pain while optimizing pelvic floor symptoms. The primary aim of this study was to compare both perioperative pelvic muscle training and vaginal reconstructive surgery among women who experienced or lacked preoperative pain and to inform better approaches to management of women with preoperative pain. The study was a secondary analysis of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) randomized clinical trial, as performed via the Pelvic Floor Disorders network. The main study's design was a 2 × 2 randomized factorial design with a surgical intervention and a perioperative behavioral intervention. The Eunice Kennedy Shriver National Institute of Child Health and Development data and specimen hub provided the data for this study. Included were 374 women undergoing surgery for both stress urinary incontinence and stage 2–4 pelvic organ prolapse from 2008 to 2013. All participants underwent vaginal prolapse repair and midurethral sling, and were randomized to either perioperative pelvic muscle therapy or usual care. The Pain scale, the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Patient Global Impression of Improvement were all completed by patients at baseline and repeated through month 24. The OPTIMAL trial had a primary outcome of surgical success as defined by anatomical success, but the primary outcome of this secondary analysis was a change in pain scale scores over 24 months after surgery. Three hundred seventy-four women participated in the original trial, with 368 in this secondary analysis. One hundred nine of the 368 women reported preoperative pain. Women with pelvic pain were more likely to be Hispanic, but there were no differences in surgical procedures performed, hospital stay, complications (ie, bladder injury, suture exposure, etc), or estimated blood loss in women with and without pelvic pain. Women with preoperative pain experienced greater pain at all time points, but also exhibited greater pain improvement at 24 months after surgery. Women with preoperative pain had worse baseline pelvic floor symptoms than those without pain. Although women with pain and women without pain had improvements in distress symptoms measured with the Pelvic Floor Distress Inventory, women with pain saw a greater improvement after surgery. All distress subscales improved significantly more in women with pain than women without pain. One additional interesting finding was that women randomized to sacrospinous suspension and pelvic muscle therapy had greater improvements in postoperative pain than those randomized to usual care. Notably, rates of surgical anatomic success and extent of Patient Global Impression of Improvement were not different between women with and without pain. Strengths of the study include its design as a secondary analysis of a large prospective multicenter randomized controlled trial. A substantial proportion of participants reported at least moderate pain at baseline but were not selected based on preoperative pain. Women in the trial were randomized to types of vaginal reconstructive surgery and pelvic muscle training, which allowed the authors to draw conclusions in categories of physical therapy treatments and surgeries for women with and without preoperative pain. Limitations of the study include a lack of preoperative pain data, pain diagnoses, and participant medications in the OPTIMAL trial. Furthermore, the study used no validated pain scale and was limited by OPTIMAL trial data collection intervals. Thankfully, data collected at numerous points over 24 months in some regard accounted for pain symptoms over time. The study found that, for patients with preoperative pain, significant improvement in pelvic floor symptoms and pain takes place after vaginal reconstructive surgery. Similar postoperative improvement rates were found. In addition, perioperative pelvic floor muscle training may be beneficial for patients with planned sacrospinous ligament fixation.

Longitudinal Reoperation Risk After Apical Prolapse Procedures in Women Aged 65 Years and Older.

To describe longitudinal reoperation risk among older women undergoing surgery for apical pelvic organ prolapse (POP) and to compare risk of reoperation for prolapse and complications among different surgical approaches. This nationwide, retrospective cohort study evaluated older adult women (aged 65 years and older) within the Centers for Medicare & Medicaid Services' (CMS) 5% LDS (Limited Data Set) who underwent sacrocolpopexy, uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF), or colpocleisis, or their uterine-preserving equivalents, from January 1, 2011, to December 31, 2018, with follow-up through 2019. The primary outcome was overall reoperation, and secondary outcomes included reoperation for POP and for complications. Rates were compared using χ 2 tests for categorical variables, Wilcoxon rank-sum for continuous variables and Kaplan Meier estimates of cumulative incidence. Death and exit from CMS insurance were considered as censoring events. We used cumulative incidence to calculate reoperation risk as a function of time at 1 year or more, 3 years or more, and 7 years or more. This cohort included 4,089 women who underwent surgery to treat apical POP from 2011 to 2018: 1,034 underwent sacrocolpopexy, 717 underwent USLS, 1,529 underwent SSLF, and 809 underwent colpocleisis. Demographics varied among patients for each POP surgery. Patients who underwent the different surgeries had differences in age ( P <.01), Charlson Comorbidity Index score ( P <.01), diabetes ( P <.01), chronic obstructive pulmonary disease ( P <.01), hypertension ( P <.01), chronic pain ( P =.01), congestive heart failure ( P <.01), and concomitant hysterectomy ( P <.01). Reoperation rates were low and increased over time. The overall reoperation risk through 7 years was 7.3% for colpocleisis, 10.4% for USLS, 12.5% for sacrocolpopexy, and 15.0% for SSLF ( P <.01). Reoperation for recurrent POP through 7 years was 2.9% for colpocleisis, 7.3% for sacrocolpopexy, 7.7% for USLS, and 9.9% for SSLF ( P <.01). Reoperation for complications through 7 years was 5.3% for colpocleisis, 8.2% for sacrocolpopexy, 6.4% for USLS, and 8.2% for SSLF ( P <.01). The type of surgical repair is significantly associated with long-term risk of reoperation. Colpocleisis offers the least likelihood of reoperation for prolapse, followed by sacrocolpopexy; colpocleisis followed by USLS has the least risk of long-term reoperation for complication.

Surgical management practice of pelvic organ prolapse among Ethiopian gynecologists, 2021: a descriptive study

IntroductionPelvic Organ Prolapse is the descent of one or more of the anterior vaginal wall, posterior vaginal wall, the uterus, or the apex of the vagina. Surgical intervention addresses both anatomical defect and associated symptoms. The landscape of prolapse surgery has been evolving constantly over years. Emerging evidences either support or challenge existing surgical treatment options, making urogynecology a dynamic field. In Ethiopia, the surgical management of pelvic organ prolapse has transitioned from abdominal to vaginal hysterectomy, supplemented later by McCall’s culdoplasty. Disparities exist in the national uniformity of surgical approaches, linked to the establishment of Urogynecology centers in certain institutions.ObjectivesThis study was done to assess the surgical management practice of Ethiopian gynecologists on pelvic organ prolapse.MethodsA cross-sectional study encompassing all Gynecologists in Ethiopia took place between January to June 2021. Information was gathered through online Google forms crafted in English. Subsequently, the collected data underwent verification, coding, and entry into Epi info 7 before being exported to SPSS version 22 software for descriptive statistical analysis.ResultsWe reached 280 gynecologists out of the 450 practicing in the Ethiopia making 62% response rate. Anterior colporrhaphy (98.6%), vaginal hysterectomy with McCall’s cul-do-plasty (51.8%), and Posterior colporrhaphy (97.5%) were the most commonly performed surgical procedures for anterior vaginal wall prolapse, apical prolapse (uterine/cervical), and posterior vaginal wall prolapse respectively. Only 3.2% and 0.7% of the gynecologists conducted abdominal and vaginal paravaginal repair for anterior vaginal wall prolapse. Sacrospinous ligament fixation and sacrocolpopexy for apical prolapse were carried out by 32.9% and 9.3% of the gynecologists respectively. Site-specific posterior repair for posterior vaginal wall prolapse was performed only by 23.9% of the gynecologists. The main reasons mentioned not to perform paravaginal repair, sacrocolpopexy, sacrospinous ligament fixation, and site-specific posterior repair were lack of skill and lack of appropriate materials.Conclusion and recommendationMost gynecologists in Ethiopian continue to perform vaginal hysterectomy and colporrhaphy procedures for treatment of pelvic organ prolapse due primarily to lack of skill and appropriate materials to perform the alternative procedures. Implementing short term training on alternative surgical treatment options of pelvic organ prolapse with provision of suitable materials and increasing the number of urogynecologists in the country in the long run holds the potential to enhance the standard of care of women with the condition.

The Variation of Chargemaster Price Listings for Urogynecologic Procedures.

A 2018 Executive Order calling for price transparency required hospitals to publicly provide chargemasters, which are detailed lists of standard price listings for billable medical procedures. The objective of this study was to evaluate price listing variations in common urogynecology procedures. This was a cross-sectional study of chargemasters obtained between February and April 2020 from hospitals across 5 states chosen to reflect the diversity of health systems in the United States. Hospital characteristic and quality metric data were obtained from the Homeland Infrastructure Foundation, U.S. Department of Agriculture, and U.S. Centers for Medicare & Medicaid Services websites. Current Procedural Terminology codes and procedure names for 9 urogynecologic procedures were used to search each chargemaster and extract price listings. Price listings were compared with data on quality, population demographics, and hospital characteristics to determine if any significant relationships existed. Eight hundred thirty-four chargemasters were identified. Price listings for most procedures differed significantly across the 5 states, including colpocleisis, cystoscopy with chemodenervation, diagnostic cystoscopy, diverticulectomy, sacral neuromodulation, midurethral sling, and sacrospinous ligament fixation. Price listings were significantly higher in urban hospitals than rural hospitals for 6 procedures. No significant association was seen with price listing and quality measures for most procedures. Listed prices varied for several urogynecologic procedures. Some of this variation is associated with hospital characteristics such as urban setting. However, notably, price listing was not associated with quality. Further investigation of chargemaster price listings with hospital characteristics and quality metrics and with what is actually paid by patients is imperative for patients to navigate charges.

Medium-term outcomes of laparoscopic pubocervical fascia reconstruction and sacrospinous ligament fixation with posterior approach for a pelvic organ prolapse: A retrospective study of 124 cases

ObjectivePelvic organ prolapse (POP) is a common gynecological disease in middle-aged and older women that seriously affects patients' physical health and quality of life, increases the financial burden for patients, and becomes a major public health concern. The aim of this study was to investigate the medium-term outcomes of laparoscopic pubocervical fascia reconstruction and sacrospinous ligament fixation with a posterior approach for patients with severe POP. MethodsPatients with severe POP quantitation stage III–IV who underwent laparoscopic pubocervical fascia reconstruction and sacrospinous ligament fixation with a posterior approach at the Department of Obstetrics and Gynecology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine between September 2016 and December 2020 were enrolled in this study. The results and complications were recorded. Data were retrospectively reviewed. ResultsIn total, 124 patients were analyzed. Patients were followed up for 32.27 ± 12.90 months. The objective cure rate for patients who underwent hysterectomy was 91.7% (100/109), with 7 (6.4%) patients had anterior vaginal wall prolapse and 2 (1.8%) patients had posterior vaginal wall prolapse. The objective cure rate for patients who retained uterus was 66.7% (10/15). All 5 patients with recurrence had uterine prolapse, and 3 (20.0%) of them also had anterior vaginal wall prolapse. ConclusionsLaparoscopic pubocervical fascia reconstruction and sacrospinous ligament fixation with the posterior approach is a safe, minimally invasive, and effective method for patients with severe POP. Long-term follow-up is needed to confirm the clinical effects.

Levator Ani Avulsion in Ultrasound Increases Recurrence in Sacrospinous Fixation.

Pelvic floor translabial ultrasound (TLUS) can identify levator ani muscle (LAM) avulsion and ballooning, which some studies have shown to be possible risk factors for prolapse recurrence. Our group uses TLUS to counsel patients preoperatively. If any of these risk factors exist, we offer sacrocolpopexy over vaginal repair. However, some patients, even though they have these possible risk factors, prefer to undergo vaginal surgery. The objective of this study was to determine if TLUS LAM avulsion and/or ballooning are risk factors for composite outcome recurrence in patients undergoing sacrospinous ligament fixation for pelvic organ prolapse. This was a retrospective observational study. All patients with vaginal apical repair with sacrospinous ligament fixation with preoperative TLUS were included. Demographics, clinical characteristics, and follow-up were analyzed. Multivariable logistic regression analysis was performed for composite outcome that included TLUS risk factors, age, Pelvic Organ Prolapse Quantification System measurements and stage, and variables with P < 0.1 in the univariate analysis. Eighty-two patients were included. All patients had symptomatic vaginal bulge; 65.4% had stage III prolapse. Concomitant hysterectomy was performed in 54.3%. Median follow-up was 20 months (interquartile range, 8-35 months); 19.8% had LAM avulsion, and 43.2% had ballooning. Anatomic recurrence rate was 23.5%, symptomatic was 22.2%, and reoperation was 1.2%. The composite recurrence rate was 29.6%. In the multivariable logistic regression analysis, unilateral/bilateral avulsion in TLUS was found to be a significant risk factor for composite outcome with an odds ratio of 4.33 (confidence interval, 1.219-15.398; P = 0.023). Composite outcome of recurrence in our study was 29.6%. Avulsion on TLUS increased the risk of recurrence of pelvic organ prolapse by fourfold.

Complications during Vaginal Sacrospinous Fixation along with McCall Culdoplasty in Stage III and IV POP

In Bangladesh, about half a million women are suffering from stage III or IV pelvic organ prolapse (POP). With traditional surgical methods, there is a chance of recurrence, especially of apical prolapse. Sacrospinous fixation (SSF) along with MacCall Culdoplasty during vaginal hysterectomy can reduce this recurrence rate enormously. This study was designed to identify, manage as well as to prevent per-/post-operative complications during SSF. The study period was from August 2017 to December 2021 at Kumudini Women’s Medical College and Hospital, Bangladesh. Total 335 stage III and IV utero-vaginal prolapse cases were included in this study. The surgeries performed were vaginal hysterectomy followed by modified McCall Culdoplasty and right-sided vaginal sacrospinous ligament fixation (SSF) along with anterior and posterior fascial closure and perineorrhaphy. A standard data collection sheet was used to record the information. Per-operatively, main complications were hemorrhage (3.57%) due to vessel injury and rectal injury (0.90%). The immediate early postoperative complication was buttock pain (24%). Of these, in 97.53% cases, pain subsided within 6 weeks with analgesic and counselling. Only one patient had recurrence of apical prolapse within 1st week of operation. It should be concluded that with proper knowledge of anatomy and careful surgical technique, most of the complications can be avoided. Bangladesh J Obstet Gynaecol, 2022; Vol. 37(2): 90-97

Anterior sacrospinous ligament fixation by the vaginal route in ten steps

Pelvic organ prolapse (POP) is a common condition affecting women, characterized by the descent of pelvic organs such as the vagina and uterus. While POP may not always cause symptoms, it can significantly impact a woman's quality of life. Diagnosis is typically made through clinical examination, and treatment options range from pelvic-floor physical therapy to surgery.Anterior sacrospinous ligament fixation (ASSLF) has emerged as a viable technique for treating apical prolapse vaginally. This procedure involves attaching the cervix or vaginal vault to the sacrospinous ligament, providing satisfactory results in the short term. Compared to the posterior approach, ASSLF shows similar efficacy, shorter operative time, and potentially fewer complications. Vaginal surgery offers advantages such as lower morbidity and cost, ability to address other pelvic conditions simultaneously, and suitability for managing recurrences.The presented case involves a 72-year-old woman with stage 3 cystocele, stage 3 hysterocele, stage 1 rectocele, and severe voiding dysfunction. After unsuccessful attempts with a pessary, surgical intervention becomes necessary. An instructive video article has been created to standardize the essential steps of ASSLF and facilitate resident education. The video demonstrates ten surgical steps, including installation/exposure, anterior vaginal wall infiltration, median anterior colpotomy, vesico-vaginal dissection, paravesical dissection, sacrospinous ligament suture, cystocele correction, colpotomy and vaginal wall repair, uterine anterior isthmus suture and sacrospinous ligament fixation, and colporrhaphy final closure.In conclusion, POP is a prevalent condition that can be effectively managed through techniques like ASSLF. Vaginal surgery offers several advantages, and proper training and standardization of surgical steps contribute to successful outcomes and resident education.

Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial.

To evaluate the efficacy and outcomes of the surgical treatment for pelvic organ prolapse (POP) in stages III and IV by sacrospinous ligament fixation (SSLF) or uterosacral ligament suspension (USLS) by comparing anatomical and subjective cure rates and quality-of-life parameters (through the version validated for the Portuguese language of the Prolapse Quality of Life [P-QoL] questionnaire) under two definitions: genital prolapse Ba, Bp, and C < -1 (stage I) and Ba, Bp, and C ≤ 0 (stage II). After we obtained approval from the Ethics Committee (under CAAE 0833/06) and registered the study in ClinicalTrials.gov (NCT01347021), 51 patients were randomized into two groups: the USLS group (N = 26) and the SSLF group (N = 25), with follow-up 6 and 12 months after the procedures. There was a significant improvement in the P-QoL score and anatomical measurements of all compartments in both groups after 12 months (p < 0.001). The anatomical cure rates in the USLS and SSLF groups, considering stage 1, were of 34.6% and 40% (anterior) respectively; of 100% both for groups (apical); and of 73.1% and 92% (posterior) respectively. The rates of adverse outcomes were of 42% (N = 11) and 36% (N = 11) for the USLS and SSLF groups respectively (p = 0.654), and those outcomes were excessive bleeding, bladder perforation (intraoperative) or gluteal pain, and urinary infection (postoperative), among others, without differences between the groups. High cure rates in all compartments were observed according to the anatomical criterion (stage I), without differences in P-QoL scores and complications either with USLS or SSLF for the surgical treatment of accentuated POP.

[Effect and safety of Lasso suture hook in transvaginal sacrospinous ligament fixation].

To investigate the feasibility and safety of the Lasso suture hook in transvaginal sacrospinous ligament fixation, a total of 38 patients with vaginal vault prolapse at or above stage Ⅱ, and aged 46-75(62.7±12.5)years, who underwent transvaginal sacrospinous ligament fixation at the Second Affiliated Hospital of Soochow University from January 2018 to January 2021 were retrospectively analyzed. After complete exposure of the right sacrospinous ligament, the cervical/uterosacral ligament was sutured to the sacrospinous ligament using Lasso hook and polypropylene sutures. The completion rate of the operation, intraoperative complications, operation time, blood loss, and postoperative situations were observed, and the objective cure rate and subjective satisfaction were followed up. Transvaginal sacrospinous ligament fixation was successfully performed in all 38 patients using Lasso suture hooks. There were no bladder or rectum injuries during the operations, and no pelvic hematoma occurred. The operation time was 15-40 (24±9.5) min; the intraoperative bleeding was 20-60 (40±12.5) ml; the visual analogue scale(VAS)score was 3-5 (3.2±1.4) points on the first day of postoperative, and 2-4 (2.2±1.8) points on the third day of postoperative. No numbness or pain in buttocks and lower limbs after the operation. The 3-month follow-up results showed that the objective surgical success rate of the postoperative pelvic organ prolapse quantitation (POP-Q) score was 100% (38/38). The 1-year follow-up results showed that the objective surgical cure rate of postoperative POP-Q score was 92.1% (35/38). The score of Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20)was 42-180(120.4±44.9)before operation and 8-75 (28.0±14.3) after operation(t=15.90, P<0.001); The score of Pelvic Floor Function Impact Questionnaire-Short Form7 (PFIQ-7) was 52-214(112.8±44.5)before operation and 5-29 (14.3±6.0) after operation (t=14.40, P<0.001), and the subjective satisfaction rate is 89.5% (34/38) conducted by Patient Global Impression of Improvement (PGI-I). Transvaginal sacrospinous ligament fixation with Lasso suture hook is simple, safe, and feasible.

Laparoscopic Pectopexy versus Vaginal Sacrospinous Ligament Fixation in the Treatment of Apical Prolapse.

To compare the follow-up results of a sacrospinous ligament fixation (SSLF) technique for laparoscopic bilateral fixation of the vagina to the iliopectineal ligament via a PVDF-mesh (laparoscopic pectopexy technique, LP) in terms of cure rate and postoperative complications rate. This prospective study included 160 patients diagnosed with pelvic organ prolapse stage II-IV according to the POP-Q system. Eighty-two patients (51.25%) underwent vaginal sacrospinous ligament fixation and seventy-eight patients (48.75%) underwent the laparoscopic pectopexy procedure. The cure rate was high in both groups, 95.12% of the patients (78 out of 82) in the SSLF group and 93.59% of the patients (73 out of 78) in the LP group were cured post surgery, leading to an overall cure rate of 151 out of 160 patients. Pelvic pain was present in 5.00% of all patients, but was notably more frequent in the SSLF group (7, 8.54%) than in the LP group (1, 1.28%). Dyspareunia occurred in 4.37% of all patients, slightly more frequently in the SSLF group (6, 7.32%) than the LP group (1, 1.28%), but without significant difference. The laparoscopic pectopexy procedure has comparably positive follow-up results with the conventional sacrospinous ligament fixation procedure. Both SSLF and LP are effective in the treatment of pelvic organ prolapse, with favorable anatomical and subjective results, a high cure rate and low rates of serious postoperative complications.

Vaginal hysteropexy compared with vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: A 5-year cost-effectiveness Markov model.

Our objective was to perform a 5-year cost-effectiveness analysis of transvaginal hysteropexy (HP) via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) versus vaginal hysterectomy (VH) with apical suspension via sacrospinous ligament fixation (SS) or uterosacral ligament suspension (US) for the treatment of uterine prolapse. A decision analytic model assessed the cost-effectiveness of the surgical intervention over a 5-year horizon. This model was constructed using TreeAge® software. Healthy women undergoing surgery for uterine prolapse were modeled. A Markov model was constructed to simulate the possible recurrence of prolapse. Recurrence rates, repeat surgery for surgical failures and complication rates were modeled. Base case, sensitivity analyses and probabilistic modeling were performed. The primary outcome was the incremental cost-effectiveness ratio (ICER) of <$100 000 per quality-adjusted life year (QALY). Using the available prolapse recurrence rates and repeat surgery rates in the literature, both HP-SS and HP-US are cost-effective at a willingness-to-pay (WTP) threshold of <$100 000 per QALY. The incremental cost-effectiveness ratio (ICER) for HP-US compared to HP-SS is $90 738.14, while VH-US and VH-SS are both dominated strategies. HP-US is the optimal cost-effective strategy but decays exponentially with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. The cost-effectiveness acceptability curve (CEAC) favors sacrospinous hysteropexy until reaching a WTP threshold between $90 000 and $100 000. Hysteropexy surgical strategies are cost-effective transvaginal surgical approaches for uterine prolapse. Vaginal hysterectomy with apical suspension becomes more cost-effective with increasing probability of prolapse recurrence and need for repeat surgery after failed hysteropexy. Given the variability of prolapse recurrence rates in the literature, more comparative studies are needed to understand the cost-effectiveness relationship between these different surgical approaches.

Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair

Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain. To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair. This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020. The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation). The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events. Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen. Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair. ClinicalTrials.gov Identifier: NCT02431897.

Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension

ABSTRACT Commonly performed at the time of total vaginal hysterectomy to combat uterovaginal prolapse, uterosacral ligament suspension and sacrospinous ligament fixation are native tissue apical suspensions. Because recurrent pelvic organ prolapse increases over time after apical suspensions, nonmodifiable and modifiable risk factors have been explored. It is suggested by numerous studies that 1 risk factor for recurrent prolapse is an enlarged preoperative and postoperative genital hiatus (GH). An enlarged GH may be indicative of a caudal shift in pelvic viscera, increasing stress on vaginal supports. However, short-term follow-up, retrospective design, and lack of patient perspectives on prolapse outcomes limited the overall impact of those findings. The SUPeR trial (Study of Uterine Prolapse Procedures-Randomized) compared vaginal mesh hysteropexy with vaginal hysterectomy with uterosacral ligament suspension in a randomized trial design with long-term follow-up postoperatively. Postoperative assessments included the patient’s assessment of prolapse symptoms. The primary objective of this manuscript was to evaluate the efficacy of the vaginal hysterectomy with uterosacral ligament suspension amidst groups defined by surgical changes in GH size. The hypothesis predicted higher prolapse recurrence proportions for those with persistently enlarged GH size at 4–6 weeks postoperatively, compared with those with smaller preoperative and postoperative GH sizes. SUPeR participants included in this ancillary analysis underwent vaginal hysterectomy with uterosacral ligament suspension and then completed a 2-year follow-up. Based on preoperative to postoperative GH measurement changes, participants were divided into 3 groups. These groups were (1) persistently enlarged GH (“persistently enlarged”), (2) improved GH (“improved”), and (3) stable or normal GH preoperatively and postoperatively (“stably normal”). Prolapse was defined as any compartment with prolapse 1 cm or more beyond the hymen. The primary aim was comparison of composite surgical failure across the GH groups at 24 months, defined by any of the following conditions: anatomic failure, retreatment for prolapse, or symptoms of bothersome vaginal bulge. Secondary outcomes included the composite surgical failure components, postoperative complications, POP-Q measurements, and pain during intercourse. A total of 81 women were included in this secondary analysis. Predominant characteristics included a median age of 65.6 years, with 50 patients in the “improved group,” 14 patients in the “persistently enlarged” group, and 17 patients in the “stably normal” group. Notably, the prevalence of advanced anterior prolapse at baseline was greatest in the persistently enlarged group compared with that of both the improved and stably normal groups. Also, the prevalence of posterior colporrhaphy during the index procedure varied across groups and was more common in the improved group than the stably normal group. The surgery performed for almost all patients was a vaginal hysterectomy with uterosacral ligament suspension. The study found that following vaginal hysterectomy, after adjustment for the prevalence of advanced anterior prolapse, a woman with persistently enlarged GH at 4–6 weeks would not be at higher of composite surgical failure 2 years postsurgery when compared with other groups. The adjusted odds ratio for composite surgical failure in the persistently enlarged group compared with the stably normal group was 6.0 (95% confidence interval, 1.0–37.5; P = 0.06). Ultimately, baseline GH size is not a modifiable risk factor; however, there does appear to be an association between postvaginal hysterectomy and anterior vaginal wall prolapse when performing a presurgical and postsurgical comparison of normal GH measurements. Nonetheless, this study was not able to confirm a significant relationship between risk of recurrent prolapse and patients grouped by GH size in this manner.

Quality-of-life improvements in patients after various surgical treatments for pelvic organ prolapse.

To compare the improvements in quality of life of patients with pelvic organ prolapse (POP) treated using various surgical methods. The PUBMED, MEDLINE and Cochrane Library online databases were searched using the keywords "pelvic organ prolapse", "surgery", "PFDI-20" and "PFIQ-7" for articles published from January 2010 to December 2022 that included quality-of-life scores before and after surgery. Forty-nine articles were include. The mean postoperative PFDI-20 and PFIQ-7 scores decreased by 67.50% and 76.98%, respectively, compared with those before surgery. In 76.9% of patients, this change did not decrease with increased postoperative time. The improvement rate in PFDI-20 scores after colpocleisis did not differ statistically from that after sacrocolpopexy and was significantly higher than that after other procedures. The improvement rate in PFIQ-7 scores after colpocleisis did not statistically differ from that after high uterosacral ligament suspension and was significantly higher than that after other procedures. The improvement rate in PFDI-20 scores after transvaginal mesh-based repair (TVM) did not significantly differ from that after sacrospinous ligament fixation and was significantly lower than that after other procedures except traditional vaginal wall repair. The improvement rate in PFIQ-7 scores after TVM did not significantly differ from that after new procedures and was significantly lower than that after other procedures. Surgical treatment can significantly improve the quality of life of patients with POP. Colpocleisis may offer more advantages than those of other surgical procedures, and improvement was lower after TVM than after other procedures.

The EnPlace® sacrospinous ligament fixation-A novel minimally invasive transvaginal procedure for apical pelvic organ prolapse repair: Safety and short-term outcome results.

The EnPlace® device is a novel minimally invasive tool allowing transvaginal sacrospinous ligament (SSL) fixation of apical pelvic organ prolapse (POP). The study aimed to investigate the safety and short-term efficacy of the EnPlace® SSL fixation for significant apical POP repair. A retrospective cohort study of 123 consecutive patients (mean age 64.4 ± 11.1 years) with stage III or IV apical POP who underwent SSL fixation by the EnPlace® device. Safety and 6-month outcome results were analyzed and compared between 91 (74%) patients with uterine prolapse versus 32 (26%) patients with vaginal vault prolapse. There were no intraoperative or early postoperative complications. The mean (± standard deviation) duration of surgery was 30 ± 6.9 min and mean blood loss was 30.5 ± 18.5 mL. The average position of point C by POP-Quantification measurements before surgery and at 6 months postoperatively was 4.5 ± 2.8 cm and -3.1 ± 3.3 cm, respectively. Of 91 patients with preoperative uterine prolapse, eight (8.8%) patients developed a recurrent uterine prolapse within 6 months postoperatively. Of 32 patients with preoperative vault prolapse, two patients (6.3%) had recurrent vault prolapse. Short-term outcome results of EnPlace® SSL fixation suggest that it is a safe and effective minimally invasive transvaginal procedure for significant apical POP repair.

Clinical Effect of Uterosacral and Cardinal Ligament Fixation versus Sacrospinous Ligament Fixation of Vaginal Vault Prolapse: A Retrospective Analysis.

This study aimed at comparing sacrospinous ligament fixation (SSLF) with uterosacral and cardinal ligament fixation (USCLF) concerning complications and outcomes in patients with pelvic organ prolapse (POP). A retrospective analysis was performed on the clinical data of patients with POP stage III or above uterine prolapse treated at Wenzhou People's Hospital from January 2013 to December 2019. Patients were divided into two groups: USCLF group and SSLF group. The perioperative indicators, postoperative complications, pelvic organ prolapse quantification (POP-Q), Pelvic Floor Distress Inventory-20 (PFDI-20), and POP/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) scores of the groups were analyzed and compared. (1) The operative time and intraoperative blood loss in the USCLF group were lower than those in the SSLF group, with statistical significance (p < 0.05). (2) The incidence of postoperative buttock pain in the SSLF group was 10.7% (6/56), higher than that in the USCLF group (0/56) (Fisher's exact test, p = 0.027). (3) At one year of follow-up, significant improvement in Aa, Ba, C, Ap, and Bp values was observed in both groups (p < 0.05). The values of the Aa and Ba sites in the USCLF group were lower than those in the SSLF group one year after surgery (p < 0.05). (4) The PFDI-20 and PISQ-12 scores of the groups one year after surgery were lower than those before surgery (p < 0.05). Uterosacral and cardinal ligament suture fixation leads to less bleeding and better postoperative quality of life than preoperative and may be better than SSLF at preventing the recurrence of anterior wall prolapse after surgery.

Comparison of Early Postoperative Outcomes for Vaginal Anterior Sacrospinous Ligament Fixation with or without Transvaginal Mesh Insertion.

Pelvic organ prolapse affects one in three women, and cystocele accounts for 80% of the indications for surgery. Following the withdrawal of transvaginal mesh from the market, the objective of the present before-and-after study was to compare of the previous reference technique (UpholdTM (Boston Scientific, Marlborough, MA, USA) mesh insertion) with anterior sacrospinous ligament fixation with suturing in terms of the outcomes 2 months after surgery. We performed a retrospective, observational, before-and-after study at Lille University Medical Center (Lille, France) by including consecutive patients operated on between 2011 and 2018 for UpholdTM mesh insertion and between 2018 to 2020 for anterior sacrospinous ligament fixation. The primary outcome was the early recurrence of prolapse, and the secondary outcomes were the occurrence of early per-operative or post-operative complications and the development of de novo stress urinary incontinence. Here, 466 patients were included in the study (382 in the UpholdTM group and 84 in the anterior sacrospinous ligament fixation group). The failure rate at 2 months was 6.0% (5 out of 84) for anterior sacrospinous ligament fixation and 1.3% (5 out of 382) for UpholdTM (p < 0.01). The prevalence of acute urinary retention was significantly lower in the anterior sacrospinous ligament fixation group (3.6%) than in the UpholdTM group (14.1%; p < 0.01), as was the de novo stress urinary incontinence rate (11.9% vs. 33.8%, respectively; p < 0.01). Anterior sacrospinous ligament fixation appears to be an effective, safe alternative to mesh insertion in the management of cystocele via the vaginal approach; the early complication rate was slightly lower, but the early failure rate was slightly higher.