OBJECTIVE: Sacrospinous ligament fixation (SSLF) is a popular surgical technique for treating apical prolapse. The use of suture-capturing devices (SCD), or the more recently introduced anchor-based device (ABD), is useful for a posterior approach but essential for an anterior one. The aim of our study was to assess the safety of the ABD, which was recently introduced to our unit, compared to the traditionally used SCD.
METHODS: This was a pilot case-control study of 40 patients who had a SSLF, 20 of these represented all the patients who had the procedure with the aid of the ABD and 20 patients who had the procedure using the SCD over approximately the same duration. The main safety endpoints of this pilot study were patient reported postoperative pain scores and perioperative complications rate.
RESULTS: The population characteristics were similar. The mean postoperative pain scores differed significantly only on postoperative day 1 in favor of the suture capturing device (3.40 [2.60] vs 1.60 [1.64], p = 0.013). The mean highest pain score was similar in both groups. Peri-operative complications rates were low and comparable between both groups. According to POPQ at 6 weeks follow-up the median Ba point was higher in the ABD group and this difference was significant (-3.00 [-3.00; -2.25] vs. -2.00 [-3.00; -1.50]; p = 0.03).
CONCLUSIONS: The anchor-based device for sacrospinal ligament fixation seems to have comparable safety profile to the traditionally used suture capturing devices.

Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System.
An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter).
Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N.
The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.

The study aimed to assess the relationship between urethrovesical junction (UVJ) descent and development of de novo stress urinary incontinence (SUI) and postoperative progression of preexisting SUI following surgery for pelvic organ floor prolapse using the method of sacrospinal fixation (SSF). This was a secondary analysis of the SAME prospective randomized multicentre study (reg. no. NCT03053479) comparing three approaches to surgery for apical defects - sacropexy, SSF and transvaginal mesh.
The subanalysis included 81 patients with apical defects managed by SSF, either right-sided (N = 14, 17.3%) or bilateral (N = 67, 82.7%). Postoperative follow-up was assessed at 3 months (N = 59), 12 months (N = 47) and 24 months (N = 30). UVJ mobility at rest and with maximum effort, the Valsalva manoeuvre was determined using a standardized 3D/ 4D transperineal ultrasound protocol proposed by Dietz et al. De novo SUI and postoperative progression of preexisting SUI were ascertained from history.
Preoperative demographic data (N = 81) were as follows: BMI 27.3 kg/ m2 (16.8-44.5), age 67.0 years (31-85), and parity 2 (1-6). Concomitant anterior repair was performed in 65.4%. Postoperative progression of SUI was 45.8% at 3 months, 21.3% at 12 months, and 23.3% at 24 months. There were significant differences between preoperative and postoperative UVJ descent values at 3, 12 and 24 months (P < 0.0001). Correlations between UVJ descent at 3, 12 and 24 months postoperatively and de novo SUI or progression of preexisting SUI at 3, 12 and 24 months postoperatively were not statistically significant (P = 0.051-0.883). Correlations between differences (preoperative UVJ descent minus UVJ descent at 3, 12 and 24 months postoperatively) and de novo SUI or progression of preexisting SUI at 3, 12 and 24 months postoperatively were not statistically significant (P = 0.691-0.779).
The study showed significant changes in UVJ descent values preoperatively and at 3, 12 and 24 months after SSF. There were no significant correlations between UVJ descent and de novo SUI and postoperative progression of preexisting SUI following surgery for pelvic organ floor prolapse at 3-, 12- and 24-month follow-up. There were no signifi cant correlations between differences (preoperative UVJ descent minus UVJ descent at 3, 12 and 24 months postoperatively and de novo SUI and postoperative progression of preexisting SUI following surgery for pelvic organ floor prolapse at 3-, 12- and 24-month follow-up.

OBJECTIVE: To compare postoperative pain between patients undergoing sacrospinous ligament colpopexy (SSLF) and hysteropexy (SSLH).
METHODS: This was a retrospective cohort study of all patients undergoing native tissue SSLF and SSLH between January 2013 and March 2020. The electronic medical record was queried for demographic and perioperative data until the postoperative visit. The primary outcome was a composite incidence of any of the following: telephone calls, urgent office visits, additional analgesic prescriptions and need for intervention for pain in the buttocks, posterior thigh or perirectal area. Secondary outcomes were the incidence of persistent pain at the postoperative visit and perioperative risk factors associated with reported pain.
RESULTS: A total of 406 patients met inclusion criteria (308 SSLF, 98 SSLH). The composite pain outcome was seen in 99 patients (24.4%; 95% CI 20.5%-28.8%), and there was no statistical difference between cohorts. Persistent pain was seen in 15.6% and 13.3% of SSLF and SSLH patients at 6 weeks (p = 0.58). Twelve patients (3.0%) underwent interventions for pain, including physical therapy (2), trigger point injections (5) and suture release (5). Compared to SSLF patients, SSLH patients were more likely to need interventions (7 [7.1%] vs. 5 [1.6%], p = 0.005) and office visits (14 [14.3%] vs. 13 [4.2%], p = 0.0005) for pain.
CONCLUSIONS: There was no difference in the overall incidence of postoperative pain between patients who underwent SSLF or SSLH. However, patients who underwent hysteropexy were more likely to need intervention and office evaluation for postoperative pain.

OBJECTIVE: We hypothesize that there will be improvement in a novice learners\' confidence and skill level with sacrospinous ligament fixation (SSLF) following a pelvic model-based simulation.
METHODS: We performed a single-blinded randomized controlled trial with obstetrics and gynecology residents who were novices at SSLF. The residents were randomly assigned to two groups. The control group received a lecture on the SSLF procedure and anatomy, whereas the intervention group received the same lecture in addition to a pelvic model-based simulation session taught by urogynecologists. The residents\' knowledge of SSLF anatomy and confidence level with the procedure were measured via assessments administered before and after the educational interventions. Their technical skills were objectively assessed by one of two fellowship-trained urogynecologists who were blinded to their group allocation.
RESULTS: A total of 28 residents were recruited with 14 residents in each group and equal distribution of junior and senior trainees. None of the residents had previously performed the SSLF procedure. There was no difference in anatomical knowledge between the two groups. The intervention group showed a greater increase in their average confidence score compared with the control group: 4.0 ± 1.4 (95% CI 3.1-4.8) versus 2.6 ± 1.6 (95% CI 1.7-3.4) respectively, with p = 0.02. The intervention group also showed better objective scores in specific technical skills, such as instrument handling (p < 0.001), instrument movement/motion (p < 0.001), and speed (p = 0.01).
CONCLUSIONS: Our results demonstrate that inclusion of a pelvic model simulation significantly improves confidence and certain technical skills of novice trainees in performing SSLF.

To investigate the risk of de novo stress urinary incontinence (SUI) occurrence in women who were treated for pelvic organ prolapse (POP) with sacrospinous ligament fixation (SSLF) in addition to vaginal hysterectomy (VAH) and antero-posterior colporrhaphy (CAP) over a 24-month follow-up period.
A prospective randomized study was designed. Women without occult or obvious SUI were randomized into either one of the study groups: Group 1: VAH + CAP, and Group 2: VAH + CAP + SSLF. Postoperatively, the patients were reevaluated for de novo SUI occurrence.
A total of 150 women were analyzed [G1 = VAH + CAP (n: 77) and G2 = VAH + CAP + SSLF (n: 73)]. Mean age, parity, body mass index, menopausal status, and preoperative POP degree, grade 1 and grade 2-3 cystocele and rectocele frequencies were similar between the 2 groups. During follow-up period, de novo SUI developed in 7 patients (9.1%) of Group 1, and in 6 patients (8.2%) of Group 2 (P > 0.05). In Groups 1 and 2, POP recurrence occurred in 5 (6.4%) vs. 1 (1.3%) cases,respectively (P < 0.05).
In patients undergoing surgery for POP, the addition of SSLF did not result in an increased rate of de novo SUI. Careful patient selection, and informing the patients about the risks and benefits of the planned surgical procedure are essential steps in each case of POP.

OBJECTIVE: Innovations in suturing devices have facilitated sacrospinous ligament fixation (SSF) for the correction of vaginal vault prolapse. It is uncertain if outcomes using suturing devices differ from those using a traditional suturing technique. We hypothesize that no difference exists in the efficacy and safety 1 year after SSF for vault prolapse performed with suturing devices or using a traditional technique. The objective was to compare SSF using a suturing device with traditional SSF for the treatment of vault prolapse, regarding symptoms of prolapse recurrence, patient satisfaction, incidence of re-operation, and complications 1 year postoperatively.
METHODS: We carried out a retrospective cohort study using register-based national data from 2006 to 2013. The Swedish Quality Register of Gynecological Surgery includes assessments pre-operatively, at hospital admittance, surgery, discharge, and questionnaires at 8 weeks and 1 year after surgery. Demographic variables and surgical methods were included in multivariate logistic regression analyses.
RESULTS: In the suturing device group (SDG, n = 353), 71.5% were asymptomatic of recurrence after 1 year compared with 78.7% in the traditional SSF group (TSG, n = 195); risk difference - 7.3% (95%CI -15.2%; 0.7%). Adjusted odds ratio (aOR) for being asymptomatic 1 year postoperatively was 0.56 (95%CI 0.31; 1.02, p = 0.057). Patient satisfaction was similar in SDG and TSG (78.1% vs 78.4%). Reoperation occurred in 7.4% in the SDG compared with 3.6% in the TSG, risk difference 3.8% (95%CI 0.0%; 7.5%), aOR 3.55 (95%CI 1.10; 11.44, p = 0.03).
CONCLUSIONS: Patient satisfaction was similar 1 year after SSF, despite symptoms of recurrence being more likely and reoperation more common after using a suturing device compared with a traditional technique. The methods did not differ with regard to surgical complications.

BACKGROUND: Reported rates of gluteal pain after sacrospinous ligament fixation range from 12-55% in the immediate postoperative period and from 4-15% 4-6 weeks postoperatively. The source of gluteal pain often is attributed to injury to the nerve to levator ani or pudendal nerve. The inferior gluteal nerve and other sacral nerve branches have not been examined thoroughly as potential sources of gluteal pain.
OBJECTIVE: The purpose of this study was to further characterize anatomy of the inferior gluteal nerve and other nerves that are associated with the sacrospinous ligament from a combined gluteal and pelvic approach and to correlate findings to sacrospinous ligament fixation.
METHODS: Dissections were performed in female cadavers that had not been embalmed with gluteal and pelvic approaches. From a pelvic perspective, the closest structure to the superior border of the sacrospinous ligament midpoint was noted, and the sacral nerves that perforated the ventral surface of coccygeus muscle were examined. From a gluteal perspective, the closest distances from ischial spine to the pudendal, inferior gluteal, posterior femoral cutaneous, and sciatic nerves were measured. In addition, the closest distance from the midpoint of sacrospinous ligament to the inferior gluteal nerve and the origin of this nerve were documented. The thickness and height of the sacrospinous ligament at its midpoint were measured. Sacral nerve branches that coursed between the sacrospinous and sacrotuberous ligaments were assessed from both a pelvic and a gluteal approach. Descriptive statistics were used for data analysis.
RESULTS: Fourteen cadavers were examined. From a pelvic perspective, the closest structure to the superior border of sacrospinous ligament at its midpoint was the S3 nerve (median distance, 3 mm; range, 0-11 mm). Branches from S3 and/or S4 perforated the ventral surface of coccygeus muscles in 94% specimens. From a gluteal perspective, the closest structure to ischial spine was the pudendal nerve (median distance, 0 mm; range, 0-9 mm). Median closest distance from inferior gluteal nerve to ischial spine and to the midpoint of sacrospinous ligament was 28.5 mm (range, 6-53 mm) and 31.5 mm (range, 10-47 mm), respectively. The inferior gluteal nerve arose from dorsal surface of combined lumbosacral trunk and S1 nerves in all specimens; a contribution from S2 was noted in 46% of hemipelvises. At its midpoint, the sacrospinous ligament median thickness was 5 mm (range, 2-7 mm), and its median height was 14 mm (range, 3-22 mm). In 85% of specimens, 1 to 3 branches from S3 and/or S4 nerves pierced or coursed ventral to the sacrotuberous ligament and perforated the inferior portion of the gluteus maximus muscle.
CONCLUSIONS: Damage to the inferior gluteal nerve during sacrospinous ligament fixation is an unlikely source for postoperative gluteal pain. Rather, branches from S3 and/or S4 that innervate the coccygeus muscles and those coursing between the sacrospinous and sacrotuberous ligaments to supply gluteus maximus muscles are more likely to be implicated. A thorough understanding of the complex anatomy surrounding the sacrospinous ligament, limiting depth of needle penetration into the ligament, and avoiding extension of needle exit or entry point above the upper extent of sacrospinous ligament may reduce nerve entrapment and postoperative gluteal pain.

OBJECTIVE: We sought to evaluate the feasibility and safety of SeraPro(®) (Serag-Wiessner, Germany), an innovative reusable suturing device for vaginal sacrospinous ligament fixation.
METHODS: We reviewed the electronic files of all women who underwent vaginal sacrospinous ligament fixation with SeraPro(®) for apical pelvic floor prolapse, with or without mesh implant, performed between April 2013 and September 2013. Preoperative demographic, clinical, operative and postoperative data were analyzed. The women were interviewed and examined before the procedure, at one month postoperatively and tele-interviewed again after three months.
RESULTS: Overall, 88 women were included in the study. Fifty-three patients (60.2%) had additional anterior mesh placement, 42 (47.7%) had posterior mesh, and 16 (18.2%) had both anterior and posterior mesh insertion. Five patients (5.7%) had no mesh implant. Sixteen patients (18.2%) had an additional mid-urethral sling for the treatment of stress urinary incontinence. No significant technical difficulty was recorded at the procedures. None of the patients had significant long-term morbidity. The mean 3-month follow-up demonstrated significant anatomical and functional improvement.
CONCLUSIONS: The SeraPro(®) reusable suturing device is a feasible and safe tool for sacrospinous ligament fixation during vaginal pelvic floor reconstruction.