Transvaginal Native Tissue Repair Research Articles

Apical Suspension Repair for Vaginal Vault Prolapse

The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. ClinicalTrials.gov Identifier: NCT02676973.

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair

The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was280. Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval,-0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Vaginal Cuff Self-Suspension Technique: A Novel Apical Suspension Technique for Patients With Uterovaginal Prolapse and Poor Tissue Integrity [ID 2683606

INTRODUCTION: Of all surgical approaches to correct apical prolapse, transvaginal native tissue repair (TNTR) accounts for 80–90% of cases. Conditions such as uncontrolled diabetes lead to poor tissue integrity, often rendering the anatomical structures necessary insufficient, resulting in recurrent prolapse or immediate procedure failure. We present a novel TNTR technique, called “vaginal cuff self-suspension technique” (VCST) that can be used in such cases to provide a potentially more reliable and efficient means of apical suspension. METHODS: We conducted a prospective observational study from July 2022 to July 2023 and followed all patients who underwent a total hysterectomy and subsequent TNTR for advanced uterovaginal prolapse and concurrent stage IV endometriosis or uncontrolled diabetes. Advanced uterovaginal prolapse was defined as either a POP-Q score of 3 or 4 or Baden-Walker Grade 3 or 4. Patients receiving VCST were compared with matched controls receiving other TNTR methods. The primary outcomes were recurrent apical prolapse at 6 months or failure at initial surgery, as discrete events. All appropriate IRB approvals were obtained. RESULTS: The study included 88 patients with 33 receiving VCST and 55 controls. Of the 55 controls, 42 utilized uterosacral ligament suspensions (USLS) and 13 utilized sacrospinous ligament fixations. Demographic factors were not significantly different. Patients receiving VCST had lower rates of initial failed suspension (6% versus 23%; P=.002) as well as a 37% decreased risk in confounder-adjusted models (risk ratio [RR] 0.63; 95% CI, 0.36–0.81; P=.003). Among patients with poorly controlled diabetes, the VCST had lower rates of recurrent prolapse (9% versus 47%) and a 81% decreased risk in confounder-adjusted models (RR 0.19; 95% CI, 0.08–0.31; P&lt;.001). CONCLUSION: Vaginal cuff self-suspension technique offers a simple and effective way to potentially prevent recurrent apical prolapse and/or immediate procedure failure for patients with advanced uterovaginal prolapse and concurrent stage IV endometriosis or poorly controlled diabetes.

Review of Vaginal Approaches to Apical Prolapse Repair.

To review recent literature and provide up-to-date knowledge on new and important findings in vaginal approaches to apical prolapse surgery. Overall prolapse recurrence rates following transvaginal apical prolapse repair range from 13.7 to 70.3% in medium- to long-term follow-up, while reoperation rates for prolapse recurrence are lower, ranging from 1 to 35%. Subjective prolapse symptoms remain improved despite increasing anatomic failure rates over time. The majority of studies demonstrated improvement in prolapse-related symptoms and quality of life in over 80% of patients 2-3years after transvaginal repair, with similar outcomes with and without uterine preservation. Contemporary studies continue to demonstrate the safety of transvaginal native tissue repair with most adverse events occurring within the first 2years. Transvaginal apical prolapse repair is safe and effective. It is associated with long-term improvement in prolapse-related symptoms and quality of life despite increasing rates of prolapse recurrence over time. Subjective outcomes do not correlate with anatomic outcomes.

Native Tissue Posterior Compartment Repair for Isolated Posterior Vaginal Prolapse: Anatomical and Functional Outcomes.

Background and Objectives: Posterior compartment prolapse is associated with constipation and obstructed defecation syndrome. However, there is still a lack of consensus on the optimal treatment for this condition. We aim to investigate functional, anatomical, and quality-of-life outcomes of native tissue transvaginal repair of isolated symptomatic rectocele. Materials and Methods: We retrospective analyzed patients who underwent transvaginal native tissue repair for stage ≥ II and symptomatic posterior vaginal wall prolapse between January 2018 and June 2021. Anatomical and functional outcomes were evaluated. Wexner constipation score was used to assess bowel symptoms, while the Patient Global Impression of Improvement (PGI-I) score was used to evaluate subjective satisfaction after surgery. Results: Twenty-eight patients were included in the analysis. The median age was 64.5 years, and half of them underwent a previous hysterectomy for benign reasons. The median follow-up time was 33.5 months. A significant anatomical improvement in the posterior compartment was noticed compared with preoperative assessment (p < 0.001 for Ap and Bp), with only two (7.1%) anatomical recurrences. Additionally, obstructed defecation symptoms decreased significantly compared to baseline (p < 0.001), as well as vaginal bulging, with no new-onset cases of fecal incontinence or de novo dyspareunia. PGI-I resulted in 89.2% of patients being satisfied (PGI-I ≥ 2), with a median score of 1.5. Conclusions: Transvaginal native tissue repair for isolated posterior prolapse is safe and effective in managing bowel symptoms, with excellent anatomical and functional outcomes and satisfactory improvement in patients’ quality of life.

Voiding function after sacrocolpopexy versus native tissue transvaginal repair for apical pelvic organ prolapse in an ERAS era: A retrospective cohort study.

ObjectiveThe objectives of this study were to compare time to return of voiding function and associated complications in women undergoing minimally invasive sacrocolpopexy (SCP) versus transvaginal native tissue repair in patients with same-day or early discharge.MethodsThis was a retrospective cohort study conducted at a tertiary care center. The electronic medical record system was queried for women who underwent native tissue vaginal repair or SCP for apical prolapse between March and December 2020 using CPT codes for sacrocolpopexy (57425), extraperitoneal (57282), and intraperitoneal colpopexy (57283). Voiding success was our primary outcome and was defined by a postvoid residual < 150 ml. Secondary outcomes included catheter days and urinary tract infections. The total number of participants was based on a power calculation using internal institutional rates. Participants were compared based on the surgical approach. A multivariate regression analysis was performed to assess for confounding factors.ResultsWe included 134 women: 63 SCP and 71 native tissue. The failure rate of the first postoperative voiding trial was 34 vs. 11% (odds ratio: 4.91; 95% CI 1.96–12.3, p < 0.01) in the vaginal and SCP groups, respectively. Both groups had a similar success rate of a second voiding trial (100% in SCP group vs. 95.7% in the vaginal repair group, p = 1). The total number of days (3.108 vs. 1.603 days, p < 0.01) to return of bladder function, postoperative urinary tract infections (23.9 vs. 6.35%, p < 0.01) and emergency department visits (15.5 vs. 1.59%, p < 0.01) were all higher in the vaginal repair group.ConclusionsVaginal apical native tissue repair had a fivefold greater risk of acute postoperative urinary retention compared to sacrocolpopexy in addition to increased rates of post-operative urinary tract infection and emergency department visits for urinary tract concerns.

Opioid prescribing and risks among commercially insured women undergoing pelvic organ prolapse repair.

Opioid use after surgical repair for pelvic organ prolapse (POP) is intended for short-term post-operative pain. This study compared the incidence of opioid prescribing in women undergoing POP transabdominal repair with mesh and transvaginal native tissue repair. A retrospective cohort of women undergoing POP transabdominal repair with mesh or transvaginal native tissue repair, was derived from a 10% random sample of enrollees from 2007 to 2015 within the IQVIA PharMetrics® Plus Database. Primary outcomes were any prescription of opioids and cumulative days of opioids prescribed in the 14- 180 days following surgical intervention. Inverse probability of treatment weights controlled for observed baseline confounders. Any opioid prescription was estimated using logistic regression and generalized linear regression for cumulative days of opioids prescribed. The cohort of 49 052 women who underwent POP surgical repair included 46 813 women with transvaginal native tissue repair and 2239 women with transabdominal repair with mesh. Women with a transabdominal repair with mesh had a 1.19 (95%CI: 1.09-1.31) significantly higher odds of receiving an opioid prescription than women with transvaginal native tissue repair. Post-operatively, over 29% of women received opioid prescriptions. Mean cumulative days of post-surgical opioid prescribing was 32.2 (SD=43.1), and was not statistically different between groups. Thirteen percent of women were prescribed opioids for 90 days or more. Women undergoing POP with transabdominal mesh are more likely to receive prescriptions for opioids after surgery compared to transvaginal native tissue repair. Treatment plans that address pain while mitigating the risks associated with prolonged opioid prescribing should be employed.

Cost analysis of four types of surgeries for pelvic organ prolapse in a Japanese population.

To compare the perioperative costs analysis between laparoscopic/transvaginal and the mesh/non-mesh surgeries for pelvic organ prolapse (POP) in Japan. From April 2013 to April 2017, 890 patients who underwent POP surgeries were enrolled in this study. Regarding transvaginal native tissue repair (TV-NTR: transvaginal hysterectomy with colpocleisis), transvaginal mesh surgery (TVM), laparoscopic native tissue repair (L-NTR: laparoscopic hysterectomy and uterosacral ligament colposuspension), and laparoscopic sacrocolpopexy (LSC), a retrospective observational study was performed. Patients' age, operation time, blood loss, perioperative complications, length of hospital stay, pre-/postoperative quality of life (QOL) scores, were reviewed from the medical records. The net income, which was calculated by using the income (the operation/anesthesia fee) and the costs (the labor and consumables costs for operation/anesthesia), was evaluated. The operation fees of the L-NTR ($4250) and the LSC ($4833) groups were higher than that of the TV-NTR ($2652) and the TVM ($2913) groups. The labor costs and consumables costs of operation were higher in the LSC ($1589) and the L-NTR ($1500) groups than the TV-NTR ($180) and the TVM ($178) groups. The consumables costs for anesthesia in the four groups were equal. The operation hours were significantly shorter in the TV-NTR and the TVM groups than the L-NTR and the LSC groups. We found that TVM operation was an economically excellent and the most efficient POP operation with shorter operation time and less consumables.

Prolapse Repair Using Non-synthetic Material: What is the Current Standard?

Due to recent concerns over the use of synthetic mesh in pelvic floor reconstructive surgery, there has been a renewed interest in the utilization of non-synthetic repairs for pelvic organ prolapse. The purpose of this review is to review the current literature regarding pelvic organ prolapse repairs performed without the utilization of synthetic mesh. Native tissue repairs provide a durable surgical option for pelvic organ prolapse. Based on recent findings of recently performed randomized clinical trials with long-term follow-up, transvaginal native tissue repair continues to play a role in the management of pelvic organ prolapse without the added risk associated with synthetic mesh. In 2019, the FDA called for manufacturers of synthetic mesh for transvaginal mesh to stop selling and distributing their products in the USA. Native tissue and non-synthetic pelvic organ prolapse repairs provide an efficacious alternative without the added risk inherent to the utilization of transvaginal mesh. A recent, multicenter, randomized clinical trial demonstrated no clear advantage to the utilization of synthetic mesh. Furthermore, transvaginal native tissue repairs have demonstrated good long-term efficacy, particularly when anatomic success is not the sole metric used to define surgical success.

Perioperative morbi-mortality after pelvic organ prolapse surgery in a large French national database from gynecologist surgeons

ObjectiveTo assess morbidity and mortality following pelvic organ prolapse surgery in France, irrespective of the surgical technique, using a broad national database.Materials and methods: This descriptive multicenter retrospective study was conducted using a database populated via an application run by a professional association. Results286 gynecologists contributed data to the database. Of the 4322 surgeries analyzed, an abdominal approach was used in 975 of cases (22.5%), a vaginal approach in 3277 (75.9%), and a combined approach in 68 (1.6%). After one year, abdominal surgery was associated with higher rates of de novo urinary incontinence, constipation, and intestinal obstruction, whereas vaginal surgery was associated with higher rates of urinary retention, hematoma, de novo chronic pain, and vaginal mesh extrusion. There was no significant difference between the groups in the incidence of severe complications. After one year, vaginal mesh-augmented cystocele repair was associated with higher rates of de novo urinary incontinence, de novo chronic pain, and reoperation than native tissue repair. Mesh repair was also associated with higher rates of severe complications at one year. ConclusionAfter pelvic organ prolapse surgery, the perioperative morbidity and mortality associated with transabdominal and transvaginal approaches are similar. However, transvaginal mesh repair is associated with greater perioperative morbidity than transvaginal native tissue repair.

Impact of age on mid- to long-term outcomes of transvaginal native tissue repair for apical vaginal prolapse.

To compare surgical success rates in older versus younger women a minimum of 3 years post transvaginal native tissue repair for apical prolapse. Post-operative symptom severity and quality of life improvement, surgical complications and retreatment were also examined. Women who underwent transvaginal native tissue repair for apical prolapse between 2011 and 2013 were eligible. Subjects completed the pelvic floor distress inventory (PFDI-20), pelvic floor impact questionnaire (PFIQ-7), and patient global impression of improvement (PGI-I), and were categorized as "younger" (age <70) or "older" (age ≥70). The primary outcome of surgical success was defined as the absence of bulge symptoms and no re-treatment for prolapse. Of 641 eligible patients, response rate was 51.0%. 62.7% of subjects had hysterectomy prior to index surgery. Surgical success was noted in 72.9% of younger and 82.2% of older subjects (Adjusted odds ratio [aOR] 1.72, 95% CI [0.93, 3.17]). Older women had greater improvement from baseline in PFDI-20 score (-87.5 [IQR 74.0] vs -54.2 [IQR 80.2], P = 0.01). Retreatment rate and surgical complication rates were similar between groups (both P > 0.05). Older and younger women had similar surgical success rates a minimum of 3 years post-operative; however, older women had a greater overall symptom severity improvement. This information may be helpful in counseling older women regarding surgical expectations and decision-making.

Severe Pelvic Organ Prolapse with Large Vaginal Mucosal Defect Underwent Laparoscopic Shull’s Uterosacral Ligament Colpo-Suspension and TVM Operation by Two Stage Surgery

A 75-year-old woman complained of anuria and a sense of discomfort with severe pelvic organ prolapse (POP). We planned tension-free vaginal mesh (TVM) surgery after curing mucosal defects and completing treatment for diabetes mellitus. Anuria and pyelonephritis relapsed repeatedly due to the failure of ring pessary therapy. Surgical treatment was required emergently. We performed a total laparoscopic hysterectomy and uterosacral ligament colpo-suspension (Shull’s method). Although the vaginal apex was supported to a good position, cystocele occurred six months after the initial surgery. A TVM procedure for recurrent cystocele was performed after curing the mucosal defects, and after the improvement of glycemic control. Transvaginal native tissue repair has the advantages of low risk of ureter injury, firm colpo-suspension, and no need for mesh usage. On the other hand, it is not good at treating cystocele. Transvaginal native tissue repair should prove to be a useful surgical option for apical support without mesh.