Sacrospinous ligament fixation versus posterior intravaginal slingplasty for apical pelvic organ prolapse: a prospective randomized controlled trial

Authors

Abstract

Aim To compare the short-term anatomical and functional outcomes of sacrospinous ligament fixation (SSLF) and posterior intravaginal slingplasty (PIVS) in women with apical pelvic organ prolapse (POP).
Materials and Methods This single-center, prospective randomized controlled trial was conducted at Fırat University Faculty of Medicine between September 2007 and October 2008. Forty women with stage II or higher apical POP were randomized to undergo SSLF (n = 20) or PIVS (n = 20). The primary outcome was anatomical success at six weeks, defined as POP-Q stage < II. Secondary outcomes included operative time, blood loss, perioperative complications, postoperative pain (VAS), hospital stay, quality-of-life and sexual function scores (PFDI-20, PFIQ-7, PISQ-12, PQoL), and patient satisfaction. Statistical analysis was performed using Student’s t, Mann–Whitney U, and chi-square tests, with p<0.05 considered significant.
Results Baseline characteristics were comparable between groups. PIVS was associated with a shorter mean hospital stay (2.6 vs. 3.7 days, p = 0.004) and lower postoperative pain scores (2.9 vs. 4.3, p = 0.001). At six weeks, anatomical success was achieved in 80% of SSLF and 85% of PIVS patients (p = 0.71). Functional outcomes and patient satisfaction were comparable, and no early mesh erosion was observed.
Discussion Both SSLF and PIVS provided effective short-term correction of apical prolapse. Considering its mesh-free design and favorable safety profile, SSLF remains the preferred native-tissue vaginal approach. Longer-term studies are warranted to confirm durability and comparative outcomes.

Keywords

Introduction

Pelvic organ prolapse (POP) is a common condition, affecting up to 50% of parous women over 50 years of age on examination, although only 3–6% are symptomatic [1, 2]. Its prevalence increases markedly with advancing age. Among the pelvic compartments, apical prolapse involving the uterus or vaginal vault represents the cornerstone of pelvic floor dysfunction, as inadequate apical support predisposes to recurrence of anterior or posterior defects [3].
Sacrospinous ligament fixation (SSLF) is one of the most established transvaginal procedures, providing satisfactory anatomical and functional outcomes but with potential drawbacks such as buttock pain and anterior compartment recurrence [4]. Posterior intravaginal slingplasty (PIVS) was introduced as a minimally invasive alternative; however, concerns regarding mesh erosion and long-term safety have limited its current use [5]. Long-term data suggest that SSLF yields durable anatomical correction, though recurrence and retreatment remain clinical considerations [6].
Given the ongoing debate over the optimal surgical approach for apical defects and the limited randomized evidence directly comparing SSLF and PIVS, this prospective randomized trial was conducted to evaluate and compare their short-term efficacy and safety in the management of apical POP.

Materials and Methods

Trial Design
This prospective, randomized clinical trial was conducted in the Department of Obstetrics and Gynecology, Fırat University Faculty of Medicine, between September 2007 and October 2008. The study was performed in accordance with the ethical principles of the Declaration of Helsinki and was reported in compliance with the CONSORT 2001 statement [7]. Written informed consent was obtained from all participants prior to enrollment.
Participants and Eligibility Criteria
Women aged 18 years or older who presented with symptomatic apical pelvic organ prolapse (uterine or post-hysterectomy vaginal vault prolapse) of stage II or higher according to the Pelvic Organ Prolapse Quantification (POP-Q) system were included.
Exclusion criteria comprised active pelvic infection, prior apical mesh repair, gynecologic malignancy, pregnancy, severe cardiopulmonary disease that precluded anesthesia, or inability to provide informed consent.
Sample Size, Randomization, and Allocation
Sample size estimation was based on the primary endpoint of anatomical success at six weeks. Assuming success rates of 75% for sacrospinous ligament fixation (SSLF) and 40% for posterior intravaginal slingplasty (PIVS), 18 participants per group were required to achieve 80% power at a two-sided α of 0.05. To compensate for possible attrition, the total sample size was increased to 46, as shown in the CONSORT flow diagram (Figure 1).
Of 67 women screened, 21 were excluded (15 not meeting inclusion criteria, 6 declining participation). The remaining 46 were randomized equally to SSLF (n = 23) or PIVS (n = 23) using a computer-generated sequence with variable block sizes.
Allocation concealment was maintained through sequentially numbered, sealed opaque envelopes prepared and managed by an independent resident not involved in patient recruitment or surgery. Although blinding of surgeons and participants was not feasible, postoperative outcomes were assessed by independent examiners blinded to group assignment.
Preoperative Evaluation
All participants underwent a comprehensive preoperative assessment that included demographic characteristics, detailed obstetric and gynecological history, and general physical as well as pelvic examination. The severity of pelvic organ prolapse was documented according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
Validated questionnaires were administered to evaluate quality of life and sexual function, including the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Prolapse Quality of Life Questionnaire (PQoL). Routine preoperative laboratory investigations and urinalysis were performed for all participants.
Surgical Procedures
All operations were performed by experienced urogynecologic surgeons under spinal or general anesthesia. A single dose of intravenous cefuroxime (1.5 g) was administered 30 minutes before incision.
Sacrospinous Ligament Fixation (SSLF): A posterior midline vaginal incision was made, and the pararectal space was dissected to expose the right sacrospinous ligament. Two delayed-absorbable 0 polydioxanone sutures were placed about 2 cm medial to the ischial spine, and the vaginal apex was attached to the ligament. Concomitant anterior or posterior colporrhaphy was performed as required.
Posterior Intravaginal Slingplasty (PIVS): A midline incision was made in the posterior vaginal fornix. Two trocars were inserted bilaterally through small perineal punctures in the ischiorectal fossae and advanced through the pararectal space toward the vaginal apex. A polypropylene tape (IVS Tunneler, Tyco US Surgical) was introduced to create a neoligament simulating the uterosacral ligaments and adjusted without tension. Additional pelvic floor repairs were performed when indicated.
Postoperative Care and Follow-up
All participants received standardized postoperative management. Intraoperative data, including surgery and anesthesia duration, anesthesia type, concomitant procedures, blood loss, and complications, were recorded. The operating surgeon rated procedural difficulty and postoperative pain on a 0–10 visual analogue scale (VAS).
Patients were monitored for 24–48 hours. Analgesia included nonsteroidal anti-inflammatory drugs and opioids as needed. Prophylactic antibiotics, hydration, and early ambulation were routinely provided. The urinary catheter was removed within 24 hours, and discharge followed adequate voiding and stable recovery.
Follow-up visits were scheduled at weeks 1 and 6. Early complications such as wound infection, hematoma, mesh exposure, nerve injury, or urinary retention were recorded. At six weeks, a blinded examiner performed a POP-Q assessment, with apical descent to stage II or higher defined as recurrence.
Functional outcomes were reassessed at six weeks using the preoperative questionnaires (PFDI-20, PFIQ-7, PISQ-12, PQoL). Postoperative morbidity, recurrence, and satisfaction were analyzed between groups.
Outcome Measures
The primary outcome was anatomical success at six weeks, defined as the absence of apical descent to stage II or higher on the Pelvic Organ Prolapse Quantification (POP-Q) system. Secondary outcomes included intraoperative and postoperative variables reflecting surgical safety and functional recovery. Intraoperative measures comprised operative time, estimated blood loss, anesthesia type, concomitant procedures, and perioperative complications such as bladder, ureteral, or rectal injury. Early postoperative outcomes included hospital stay, pain intensity measured on a 0–10 visual analogue scale (VAS), urinary retention, febrile morbidity, hematoma, and wound complications. Late outcomes encompassed mesh exposure or erosion, prolapse recurrence in any compartment, dyspareunia, buttock or sciatic pain, and voiding dysfunction.
Patient-reported outcomes were evaluated using the same validated questionnaires administered preoperatively (PFDI- 20, PFIQ-7, PISQ-12, PQoL). Changes in scores from baseline reflected improvements in symptoms, quality of life, and sexual function. Overall satisfaction with surgical outcomes was rated on a five-point Likert scale at the six-week follow-up.
Statistical Analysis
Data were analyzed using SPSS software, version 17.0 (IBM Corp., Armonk, NY, USA). The distribution of continuous variables was examined using the Shapiro–Wilk test to assess normality. Continuous data are presented as mean ± standard deviation (SD) or median (range), and categorical variables are summarized as frequencies and percentages. Between- group comparisons were performed using the Student’s t-test or Mann–Whitney U test, as appropriate. Categorical variables were analyzed with the chi-square or Fisher’s exact test. Within- group pre- and postoperative differences were evaluated using the paired t-test or the Wilcoxon signed-rank test. Statistical analyses were performed on a per-protocol basis, excluding participants who were lost to follow-up. An intention-to-treat (ITT) analysis was not conducted due to incomplete outcome data for these participants. All statistical tests were two-sided, and a p-value <0.05 was considered statistically significant.
Ethical Approval
This study was approved by the Ethics Committee of Fırat University Faculty of Medicine (Date: 2007-07-19, No: 2007/63).

Results

A total of 40 women were randomized, with 20 assigned to the SSLF group and 20 to the PIVS group. Baseline demographic and clinical characteristics were similar between groups. The mean age was approximately 58 years, and the mean body mass index was about 27 kg/m² in both. Most participants were postmenopausal; half had undergone hysterectomy, and about one-quarter had previous prolapse repair. Preoperative POP-Q stage III or higher was observed in comparable proportions (Table 1). Intraoperative findings showed no major differences between procedures. The mean operative time was slightly longer for SSLF (≈73 minutes) than for PIVS (≈66 minutes, p = 0.11). Estimated blood loss and the frequencies of concomitant anterior or posterior colporrhaphy were similar. No intraoperative bladder, ureteral, or rectal injury occurred, confirming the technical safety of both techniques (Table 2). During the early postoperative period, recovery was faster after PIVS, with a significantly shorter hospital stay (2.6 vs. 3.7 days, p = 0.004) and lower pain scores (2.9 vs. 4.3, p = 0.001). Urinary retention, febrile morbidity, and other complications were infrequent and comparable between groups (Table 2). At six weeks, anatomical success (POP-Q < stage II) was achieved in 80% of SSLF and 85% of PIVS patients (p = 0.71). Two participants in each group experienced apical recurrence, and other compartment recurrences were rare. No mesh erosion was detected, and transient buttock pain occurred in one SSLF case. Functional and quality-of-life outcomes improved significantly in both groups compared with baseline. Postoperative PFDI-20, PFIQ-7, PISQ-12, and PQoL scores did not differ significantly between SSLF and PIVS. Overall satisfaction was high, with approximately 85–90% of participants rating their outcomes as satisfied or very satisfied (Likert ≥ 4) at follow-up (Table 3).

Discussion

Pelvic organ prolapse (POP) is a common gynecologic disorder, affecting up to 50% of parous women over the age of 50 when assessed by physical examination, although only 3–6% report symptomatic descent [1]. As life expectancy continues to increase, the global burden of POP is expected to rise correspondingly, which highlights the need for effective and durable reconstructive options [2]. Among the various types of prolapse, apical compartment involvement holds particular importance, as it often represents the central defect in pelvic floor dysfunction. Inadequate restoration of apical support may lead to secondary recurrence in the anterior or posterior compartments [8, 9, 10]. Thus, surgical techniques designed to reestablish durable apical suspension have become a focal point of contemporary urogynecologic practice.
In this randomized controlled trial, we compared sacrospinous ligament fixation (SSLF) and posterior intravaginal slingplasty (PIVS) for the management of apical prolapse. At six-week follow-up, both procedures achieved comparable short-term anatomical success and improvements in quality of life, aligning with previous evidence indicating equivalent efficacy of SSLF and PIVS in restoring apical support during the early postoperative period [11]. Notably, PIVS was associated with a shorter hospital stay and lower early postoperative pain scores, findings that concur with earlier studies reporting faster recovery with this minimally invasive technique [12]. These short-term advantages, however, should be interpreted within the broader context of potential mesh-related risks associated with synthetic materials.
Long-term data in the literature tend to favor SSLF over PIVS in terms of durability and safety. In a 10-year follow-up study, Vigna et al. reported prolapse recurrence in more than half of women treated with SSLF, most commonly involving the anterior compartment; however, the majority of patients still experienced sustained improvement in quality of life [13]. Similarly, Ren et al. observed in a prospective 3-year cohort that SSLF provided satisfactory long-term outcomes, with an overall patient satisfaction rate of 81%, despite the occurrence of de novo dyspareunia and urinary dysfunction in some cases [14]. Recent meta-analyses, including the 2023 Cochrane Review on surgical management of apical prolapse, further support the long-term efficacy of mesh-free vaginal suspension techniques such as SSLF, emphasizing their favorable safety profile compared with mesh-based procedures [15]. Collectively, these findings suggest that while SSLF ensures durable apical suspension, anterior compartment recurrence remains a persistent limitation, which is likely related to the posterior vector of fixation that alters the vaginal axis. In our trial, no anterior compartment recurrence was observed, but extended follow-up is warranted to determine whether such defects may develop over time.
In contrast, the clinical utilization of PIVS has markedly diminished following multiple reports of mesh-related complications. Nyyssönen et al. documented vaginal mesh erosion in approximately 25% of women treated with PIVS, concluding that the procedure could not be regarded as a safe long-term option [15]. These concerns are consistent with international regulatory actions that have imposed restrictions on transvaginal mesh use, leading to a significant decline in the adoption of PIVS in modern urogynecologic practice. In our study, no early mesh complications were observed; however, this finding should be interpreted with caution, as erosion typically becomes apparent during longer follow-up periods.
Emerging minimally invasive approaches have sought to refine SSLF by reducing operative morbidity and recovery time. Neuman et al. recently reported encouraging outcomes with the EnPlace® device, noting low recurrence rates, high patient satisfaction, and short operative times among women with recurrent apical POP [16]. These findings indicate that minimally invasive SSLF techniques represent a promising direction for future research, as they may mitigate the limitations of traditional SSLF by minimizing dissection and postoperative pain. Comparative studies between SSLF and uterosacral ligament suspension (ULS) have generally shown comparable success rates, although ULS may offer advantages regarding postoperative pelvic pain and retreatment frequency [17]. This has been further supported by a large multicenter cohort demonstrating that sacrospinous hysteropexy provides satisfaction rates equivalent to vaginal hysterectomy with ULS, supporting its value as a feasible uterine-sparing option [18]. From a clinical perspective, our findings emphasize the importance of individualized patient counseling. Both SSLF and PIVS offered short-term anatomical correction and symptomatic improvement. However, the accumulating evidence supports SSLF as the preferred technique in contemporary practice because of its favorable safety profile and avoidance of mesh- related complications. Patients should be counseled regarding potential postoperative buttock or sciatic pain and the risk of anterior compartment recurrence during long-term follow- up. Conversely, the use of PIVS should be considered with caution due to the substantial risk of mesh erosion and the existing regulatory restrictions surrounding transvaginal mesh procedures.
This study has several noteworthy strengths. It is among the few randomized controlled trials directly comparing SSLF and PIVS, incorporating standardized outcome measures and validated quality-of-life instruments. The prospective design and random allocation further reduce selection bias relative to retrospective series.

Limitations

This study has several limitations. The relatively small sample size and single-center design may restrict the statistical power and generalizability of the findings. The short follow-up period did not allow for the assessment of long-term outcomes and recurrence, which are crucial in apical prolapse repair. Moreover, the results may reflect the learning curve and surgical expertise specific to a tertiary center, particularly for procedures requiring meticulous anatomical dissection such as SSLF.
Future research should focus on well-designed, multicenter randomized trials that compare SSLF with other current apical suspension techniques, including uterosacral ligament suspension and minimally invasive approaches such as laparoscopic sacrocolpopexy or transvaginal EnPlace fixation. Including patient-centered outcomes, particularly sexual function and quality of life, alongside anatomical measures, will provide a more meaningful understanding of overall surgical effectiveness. As surgical technology continues to evolve and the use of transvaginal mesh remains limited, robust long-term data will be essential to guide the selection of the safest and most effective approach for apical prolapse management.

Conclusion

Both SSLF and PIVS demonstrated effective short-term correction of apical pelvic organ prolapse. However, the accumulated evidence favors SSLF as a safer and more sustainable native-tissue option due to its mesh-free design and consistent safety profile. Despite its potential for anterior compartment recurrence, SSLF continues to represent the cornerstone of vaginal apical suspension. The refinement of minimally invasive SSLF techniques holds promise for improving surgical outcomes, and extended long-term follow-up will be essential to confirm their durability and clinical superiority.

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