A Novel Bilateral Anterior Sacrospinous Hysteropexy Technique for Apical Pelvic Organ Prolapse Repair via the Vaginal Route: a Cohort Study

Abstract

Background

Uterine preserving techniques are becoming increasingly popular in the last decade. This investigation evaluates a novel hysteropexy technique using a mesh in sling-alike configuration [Splentis (Promedon, Argentina)] which is attached anteriorly to the cervix and suspended to the sacrospinous ligaments bilaterally via the vaginal route in women undergoing surgery for uterine prolapse.

Methods

This was a single-center cohort study, evaluating women who underwent transvaginal hysteropexy with Splentis for primary uterine descent. Data has been collected prospectively as part of the quality assurance system. Primary endpoint was treatment success, defined as a combined endpoint including the absence of a vaginal bulge symptom and no retreatment of apical prolapse. A validated questionnaire to evaluate quality-of-life and prolapse symptoms was utilized. Descriptive analysis was applied. Wilcoxon signed-rank test was performed to compare paired samples. The significance level was set at 5%.

Results

A total of 103 women with a median age of 68.0 [IQR 11.5] years with a median apical POP-Q stage of 3 were included. The median surgery time was 22 [IQR 12] minutes and no intraoperative complication occurred. After a median follow-up time of 17 months, treatment success was achieved in 91 (89.2%) patients and quality of life and patient report outcomes improved significantly (p<0.001). Mesh exposure occurred in 3 (2.9%) patients. Of these, two patients required surgical revision, and one patient was treated conservatively. One patient required partial mesh removal due to dyspareunia.

Conclusion

Bilateral sacrospinous hysteropexy with Splentis offers an efficacious and safe alternative for apical compartment repair, incorporating the advantages of pelvic floor reconstruction via the vaginal route.

Trial registration

The trial has been registered at the German Clincial Trials Register (DRKS00018990). 

1. Background

Pelvic organ prolapse (POP) is defined as a downward descent of the pelvic organs that results in protrusion of the vagina, uterus, or both [1]. It is a common condition, with a prevalence of approximately 30 – 40% [2] and a lifetime risk of undergoing surgery for POP of 10 – 20% [3]. Although the uterus plays a passive role in the development of POP and hysterectomy does not necessarily correct the underlying defect in the apical vaginal support structures [4], hysterectomy was formerly most commonly performed during POP repair [5]. However, there is an increasing trend in uterine-preserving surgical techniques [6]. Clinical investigations have demonstrated that 36 – 60% of women prefer preservation of the uterus if surgical repair for symptomatic apical prolapse is required [7]. Reasons for uterine preservation include the belief of the uterus and ovaries have an impact on sexual function and activity or sense of identity and the surgical risks of hysterectomy itself [7]. The surgical risks of hysterectomy include, among others, prolonged surgery, increased blood loss, and the occurrence of enteroceles [7, 8].

There are several hysteropexy techniques that may be differentiated in regard to the route of surgical access (vaginal vs. transabdominal) and the utilization of sutures or a mesh for uterine fixation [4]. Splentis (Promedon, Cordoba, Argentina) is a lightweight, type I polypropylene mesh used in uterine-preserving techniques via the vaginal route for women with apical POP. It is designed in a sling-alike configuration; the mesh is fixed anteriorly to the cervix and suspended to the sacrospinous ligaments (SSLs) bilaterally. Importantly, in comparison to other transvaginal implanted meshes, Splentis is neither attached to, nor it is supporting the anterior vaginal wall directly. The indication for Splentis is uterine descent. The theoretical benefits include preservation of the physiological axis of the vagina. Furthermore, direct fixation to the vaginal wall is avoided, which might preserve mobility of the vagina and thus normal pelvic floor function.

The present study was performed to evaluate the efficacy and safety of vaginal sacrospinous hysteropexy using Splentis in women undergoing primary surgery for uterine descent.

2. Methods

This was a single-centre, single-arm cohort in a community maximum care hospital. The study center is a certified pelvic organ prolapse center and data has been collected prospectively as part of the quality assurance system. The protocol was approved by the ethics committee of the medical association of Thuringia, Germany (vote number: 60750/2020/26), informed consent was obtained by the patients and the trial has been registered at the German Clincial Trials Register (number: DRKS00018990) prior to patient recruitment. The investigation was performed in accordance with the principles of Good Clinical Practice and the current version of the declaration of Helsinki; international and national regulations were complied with. The manuscript was prepared in accordance with the STROBE guideline.

Non-fertile women who underwent primary transvaginal POP repair using Splentis (Promedon, Cordoba, Argentina) for uterine descent between 2017 and 2019 with a minimum follow-up time of 12 months were invited to give consent for data analysis. Non-fertile women were defined as women in menopause or permanently unable to become pregnant due to iatrogenic causes. Surgeons implanting Splentis were experienced in transvaginal pelvic floor reconstruction. The indication for hysteropexy with Splentis were non-fertile women with a symptomatic apical POP-Q≥2 and the absence of indication for hysterectomy. Women received perioperatively local estrogen therapy if not contraindicated. Patients were introduced to avoid avoid heavy lifting, excessive physical exercise and sexual intercourse or other vaginal insertions for at least six weeks after surgery.

The primary endpoint was treatment success. Treatment success was defined as a combined endpoint[10] including the patient reported outcome of absence of a vaginal bulge symptom and no need for surgical or conservative retreatment for apical POP. Emphasizing herby the importance of subjective assessment in POP surgery which has been put into focus in the recommendation of outcome success evaluation for POP surgery.[10, 11] Therefore, this certified study center evaluates systematically treatment success by the utilisation of a validated questionnaire and interview follow-up after 12 months as part of the quality assurance system. Secondary outcomes included the number of adverse events, number of further surgeries required for complications, quality of life (QoL) and estimated exposure-free and anatomical failure-free survival rates.

Demographic information, the results of the perioperative course and any unscheduled follow-up were collected from the medical records. The operative duration was defined as the time from the first incision to the end of wound closure. Complications were reported according to the Clavien-Dindo classification.

The results of a prospectively collected telephone interview and validated questionnaire, which is performed as part of the quality assessment of the study site 12 months after surgery, were included. The interview comprised by the questions regarding subjective treatment success, overall satisfaction with the surgery, the presence of vaginal bulge symptom, the presence of a palpable or visible vaginal bulge, sexual activity and dyspareunia, the occurrence of any adverse events or further surgeries since the last clinical follow-up, the utilization of a pessary, change in prolapse-related symptoms (from very much better to very much worst), pain and the presence and type of urinary incontinence. QoL and prolapse-related symptoms were assessed according to the german Pelvic Organ Prolapse Questionnaire (POP-Q) at baseline and at interview follow-up. The POP-Q is a validated, standardized QoL questionnaire for women with POP, including four domains (bowel, urinary, sexual, and prolapse symptoms) with scores ranging from 0-10 (a higher score indicates a more negative impact), as well as a total score (range, 0-40) combining the results of all domains. Pain was assessed postoperatively and at the follow-up interview using the verbal analogue scale (VAS/VRS) (range, 0-10; a higher score indicates a more negative impact).

3. Results

A total of 103 women with a median age of 68.0 [IQR 11.5] years were included. The median anterior and apical POP-Q stage was 3 at baseline. The complete list of baseline characteristics is presented in Table 1.

POP Pelvic Organ Prolapse, POP-Q Pelvic Organ Prolapse Quantification, COPD Chronic Obstructive Pulmonary Disease

The median surgery time was 22 [IQR 12] minutes, and no blood loss > 200 ml occurred. Additional anterior colporrhaphy was performed in 102 (99.0%) patients, and posterior colporrhaphy was performed in 4 (3.9%) patients. There were no intraoperative complications, particularly no cases of injury to surrounding vessels or organs. The mean postoperative pain score was 0.7 (SD 0.9). There were no postoperative complications except for two (1.9%) cases of residual urine >100 ml; these patients required either intermittent self-catheterization or pharmacotherapy with myocholine. The residual urine was completely resolved in these women at follow-up.

4. Discussion

Treatment success of apical compartment prolapse with bilateral anterior sacrospinous hysteropexy using Splentis was 89.2% after a median follow-up of 17 months. Additionally, QoL and prolapse-related symptoms improved significantly after surgery. There were three (2.9%) patients with mesh exposure of which two (1.9%) required revision surgery and one (1.4%) was treated conservatively. One (1.4%) patient required further surgery due to dyspareunia and the formation of a granulation polyp. No patient required repeat surgery or a pessary due to recurrence of an apical or anterior prolapse.

In comparison to traditional posterior sacrospinous fixation, SSL suspension with Splentis is performed using single-use instruments to place an anchor with attached sutures to each SSL. Uterine suspension is facilitated by placing a mesh in a sling-like configuration anteriorly to the cervix and suspended to the SSL bilaterally using the sutures attached to the anchors. In comparison, there are several hysteropexy techniques that may be differentiated in regard to the surgical route (vaginal vs. abdominal) and the utilization of native tissue or synthetic mesh for uterine fixation[4]. Formerly, several synthetic meshes were available for the use via the vaginal route and indicated for apical POP. These meshes had a larger surface area and were attached to the anterior vaginal wall to address the apical and anterior compartments simultaneously. However, the surface size and the attachment of mesh directly to the vaginal wall has been identified as crucial risk factors for mesh-related morbidity[12] which led to a discreditation of these meshes [13]. Furthermore, apical POP repair by sacrocolpopexy or hysteropexy techniques still often include the utilization of a mesh and these techniques have not been affected by the FDA mesh ban due to the lower risk of mesh-related morbidity. In contrast, Splentis is not attached to the vaginal wall, the mesh surface is significantly smaller and the indication is limited to apical compartment prolapse. Therefore, Splentis does not fall into the scope of mesh-augmented anterior POP repair.

Treatment success was achieved in 89.2% patients in the current investigation. No patient required repeat surgery, which is consistent with the results of other hysteropexy techniques using mesh or sutures via the abdominal or vaginal route. The overall objective treatment success rate of apical compartment repair, including any kind of transabdominal laparoscopic hysteropexy technique, was 85.3% according to a recent meta-analysis [14]. The rate of subjective treatment success has been reported range from 73 – 10%, with repeat surgery performed in 0 – 28% of patients [14]. Taking into consideration only studies that used a synthetic mesh for uterine suspension via the abdominal route, the pooled success rate was 92% [15]. Considering any native tissue repair performed via the vaginal route, the rate of treatment success in the apical compartment was reported to range from 70.2 – 89.8% [16, 17]. In particular, the reported success rate for transvaginal sacrospinous fixation ranges from 51 - 91% [4, 17, 18] with a pooled rate of repeat surgery of 3.4% [18].

In contrast to traditional posterior SSL fixation, the anterior access with Splentis ensures physiological positioning of the cervix, maintaining the possibility of common cancer screening and potentially reducing the risk of subsequent anterior prolapse. The first description of an anterior approach by Winkler et al. [19] demonstrated a restoration of the physiological horizontal axis of the vagina. Another study by Goldberg et al. [20] reported several advantages of using an anterior approach compared to a posterior approach, including a longer average total vaginal length, less anterior vaginal wall relaxation, and a more proximal vaginal apex. Posterior sacrospinous vaginal vault suspension leaves the vagina at a downward and posterior angle and may lead to a significant rate of cystoceles recurrence (22–25%) [21].

In contrast, unilateral sacrospinous hysteropexy may result in unphysiological horizontal positioning of the cervix by deflecting the vaginal axis posteriorly. Thus, the prevention and diagnosis of cervical or vaginal cancer may be reduced or even impossible because the cervix may no longer be accessible [18]. Additionally, deflection is considered to be the cause for the high rate of subsequent anterior prolapse [17] and the success rate of treatment of the anterior compartment is only 65.1% [18]. Furthermore, advanced stages of POP are correlated with increased failure rates of native tissue repair by SSL fixation [17].

However, the majority of women in the current investigation presented with a POP-Q stage of 3, indicating a cohort with a higher risk of failure for traditional transvaginal SSL fixation. Nevertheless, the treatment success rate remained high despite the advanced POP-Q stages in the current study.

Furthermore, the surgery time is reduced by using the vaginal route instead of the transabdominal approach [16, 22]. The mean surgery time via the vaginal route was reported to be 90 minutes including any native tissue repair technique[16] and 54.5 minutes for sacrospinous hysteropexy[18]. In contrast, the mean duration for laparoscopic mesh sacrohysteropexy was 174 minutes [23].

In summary, treatment success of this clinical investigation is consistent with previously reported results in the literature. Furthermore, bilateral anterior sacrospinous hysteropexy with Splentis ensures physiological positioning and mobility of the cervix, maintaining the possibility of common cancer screening.

During the perioperative course, no adverse events occurred in the current trial. Intraoperative complications, particularly visceral injuries, are rare in POP repair [18, 22]. In a large cohort trial including 507 women who were treated with laparoscopic hysteropexy, the rate of intraoperative adverse events was <1% [24]. Thus, the current results are consistent with those in the literature.

Mesh exposure occurred in three (2.9%) patients, and only two (1.9%) patients required revision surgery which is consistent with other hysteropexy techniques including mesh placement for uterine suspension. According to a recent meta-analysis of transabdominal hysteropexy using synthetic mesh, a mean exposure rate of 3.8% was reported [16, 24]. In a prospective trial investigating vaginal versus abdominal hysteropexy techniques, the reported mesh exposure rate was 2.7% and 6.6%, respectively, without a significant difference between the groups. However, the vaginal technique included the attachment of a larger area of the mesh to the anterior vaginal wall, as previously described. Another meta-analysis comparing mesh sacrocolpopexy and vaginal native tissue repair reported a mesh complication rate of 4.2% [22]. Regarding the current investigation, the mesh exposure rates are consistent with those of other hysteropexy techniques, including mesh placement for uterine suspension.

Other adverse events, particularly those associated with transvaginal mesh-augmented POP repair for anterior prolapse [25], did not occur in the current investigation. This may be related to the mesh design and, in particular, fixation of the mesh to the uterus and sparing the vaginal wall. Only one patient (0.9%) required partial mesh excision due to dyspareunia and the formation of a granulation polyp.

Dyspareunia is one of the most commonly reported adverse events after mesh-augmented vaginal procedures [26]. However, a Cochrane meta-analysis identified only little or no difference in the dyspareunia rate between mesh-augmented and native tissue apical POP repair [27]. In the current investigation, de novo dyspareunia occurred in two subjects (1.8%), and importantly, dyspareunia, which was present at baseline, resolved after surgery in six (5.5%) patients. A recent prospective randomized trial comparing laparoscopic sacrohysteropexy with mesh and sacrospinous hysteropexy with sutures reported de novo dyspareunia in 8.1% and 13.2% of patients, respectively [28]. Considering any type of vaginal native tissue hysteropexy technique, the mean dyspareunia rate was 12.3% [15]. In comparison to unilateral sacrospinous suspension, there might be an increased risk for dyspareunia due to distortion of the vaginal configuration [18]. Therefore, Splentis might be beneficial for sexual activity due to maintenance of the physiological axis of the vagina and preservation of the uterus per se [7]. However, there was no statistically significant difference in sexual function according to the POP-Q between baseline and follow-up.

We acknowledge the current limitations of this investigation. The results of objective anatomical success are not present for the cohort. Furthermore, asymptomatic findings, such as small exposure or contractures, might have been missed because vaginal examination is often performed by the patients gynecologist. However, it should be considered the current recommendation for treatment success in POP repair focus in combined endpoints, including patient report outcome[10] and solely anatomical failure does not represent indication for retreatment. It could be demonstrated that the hymen is a relevant cut-off-point as women with prolapse beyond the hymen have more POP symptoms and are more likely to report a vaginal bulge symptom which identified this question to be crucial for defining outcome success [10]. Thus, this investigation included in particular this question at interview follow-up and additionally, the patients were also asked for any further surgery performed since last follow-up. Therefore, clinically relevant results have been collected completely. Finally, the analysis of risk factors for failure or exposure may be associated with the chance of a type II error since the number of adverse events and the anatomical failure rate were low.

5. Conclusions

Bilateral anterior sacrospinous hysteropexy with Splentis offers a valid alternative for surgical correction of uterine descent while incorporating the benefits of the vaginal route. The risk-benefit ratio of Splentis seems to be favourable, and there are many theoretical benefits of this procedure that are reflected in the documented outcomes of our study.

List of abbreviations

POP Pelvic organ prolapse

POP-Q Pelvic organ prolapse quantification

PRO Patient reported outcome

SSL Sacrospinous ligament

SUI Stress urinary incontinence

TAS Tissue anchoring system

Declarations

Ethics approval and consent to participate

The protocol was approved by the ethics committee of the medical association of Thuringia, Germany (vote number: 60750/2020/26), informed consent was obtained by the patients and the trial has been registered at the German Clincial Trials Register (number: DRKS00018990) 16.03.2021 retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021072

Availability of data and materials

The datasets used and analyses during the current study are available from the corresponding author on reasonable request.

Conflicts of interest

CR Börner, LJ Naumann, S. Schröder declare that they have no conflicts of interest. T. Hüsch declares personal fees Photocure GmbH outside the submitted work. G. Naumann declares participation in clinical trials and consultancy for Promedon, Member of Advisory Board, at Dr. Pfleger GmbH.

Funding

This clinical investigation was sponsored by Promedon GmbH (Kolbermoor, Germany).

Authors contributions

T. Hüsch: protocol development, data management, analysis and interpretation, and manuscript writing. G. Naumann: protocol development, data interpretation, and manuscript editing. CR. Börner, LJ Naumann, S. Schröder: Data collection, data interpretation and manuscript editing.

Acknowledgements

This manuscript has been edited with English Language Service from Nature Research Editing Service.

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