Dataset Information

Tension-free vaginal mesh for patients with pelvic organ prolapse: mid-term functional outcomes.

ABSTRACT:

Objective

We aimed to evaluate the mid-term efficacy of tension-free vaginal mesh (TVM) for pelvic organ prolapse (POP), and observe the time course of lower urinary tract symptoms and sexual function.

Methods

In this retrospective study, we included 112 female patients who underwent TVM at a single center for stage 2 or higher POP, and replied to questionnaires before, and 2 and 4 years after TVM. We evaluated the anatomical cure rate, prolapse quality of life questionnaire scores, international prostate symptom scores, International Consultation on Incontinence Questionnaire-Short Form scores, and Female Sexual Function Index scores.

Results

The anatomical cure rate at 4 years was 89%. Voiding and storage symptoms improved in patients after TVM. We found that 25/112 patients had sexual intercourse before TVM, and among them, 15/25 (60%) continued sexual intercourse after TVM. Additionally, of the 87 patients who had no sexual intercourse before TVM, 13 resumed sexual intercourse after TVM.

Conclusion

Cases of TVM have decreased because of the Food and Drug Administration statements concerning mesh problems. However, this study showed relatively favorable mid-term results for lower urinary tract symptoms. Furthermore, sexual activity was restored in some patients, indicating the efficacy of TVM for sexual function.

SUBMITTER: Obinata D

PROVIDER: S-EPMC9235303 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Tension-free vaginal mesh for patients with pelvic organ prolapse: mid-term functional outcomes.

Obinata Daisuke D Yamaguchi Kenya K Hashimoto Sho S Yoshizawa Tsuyoshi T Mochida Junichi J Takahashi Satoru S

The Journal of international medical research 20220601 6

<h4>Objective</h4>We aimed to evaluate the mid-term efficacy of tension-free vaginal mesh (TVM) for pelvic organ prolapse (POP), and observe the time course of lower urinary tract symptoms and sexual function.<h4>Methods</h4>In this retrospective study, we included 112 female patients who underwent TVM at a single center for stage 2 or higher POP, and replied to questionnaires before, and 2 and 4 years after TVM. We evaluated the anatomical cure rate, prolapse quality of life questionnaire score ...[more]

PMID: 35734995

Similar Datasets

Project description:ImportanceMore than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness.ObjectivesTo describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy).Design, setting, and participantsLong-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years.Main outcomes and measuresSymptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index.ResultsBy year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%).Conclusions and relevanceDuring 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion.Trial registrationclinicaltrials.gov Identifier: NCT00099372.

Project description:The aim of the study was to describe the long-term outcomes of Pelvis Organ Prolapse (POP) repair in women under 40 years old. A retrospective chart review of all POP repairs performed in women ≤40 years old between January 1997 and December 2015 in the Gynecologic Surgery Department of Lille University Hospital was performed. Inclusion criteria were all women ≤40 years old who underwent a POP repair with a stage ≥2 POP according to the Baden and Walker classification. The study population was separated into three groups: a sacrohysteropexy group, a vaginal native tissue repair (NTR) group, and a transvaginal mesh surgery (VMS) group. The primary outcome was reoperation procedures for a symptomatic recurrent POP. Secondary outcomes were other complications. During the study period, 43 women ≤ 40 years old who underwent a POP repair were included and separated into three groups: 28 patients (68%), 8 patients (19%), and 7 patients (16%) in the sacrohysteropexy, VMS, and NTR groups respectively. The mean followup time was 83 ± 52 months. POP recurrence, reoperated or not, was essentially diagnosed in the VMS group (87.5%) and the NTR group (50%). POP recurrence repairs were performed for nine patients (21%): 7%, 62.5%, and 25% in the sacrohysteropexy, VMS, and NTR groups, respectively. Global reoperation concerned 10 patients (23%) whatever the type of POP surgery, mainly patients from the VMS group (75%) and from the NTR group (25%). It occurred in only 7% of patients from the sacrohysteropexy group. Two patients (4%) presented a vaginal exposure of the mesh (in the VMS group). De novo stress urinary incontinence was encountered by nine patients (21%): 29% and 12.5% in the sacrohysteropexy and NTR groups, respectively. Despite the risk of recurrence, POP repair should be proposed to young women in order to restore their quality of life. Vaginal native tissue repair or sacrohysteropexy should be performed after explaining to women the advantages and disadvantages of each procedure.

Project description:Pelvic organ prolapse is a common condition that affects 1 in 4 women across all age groups. It is mainly caused by vaginal birth injury and can be exacerbated by obesity and increased age. Until recently, treatment strategies often used non-degradable synthetic meshes for reconstructive surgery. However, owing to their frequent, unacceptable rate of adverse events such as mesh erosion, transvaginal meshes have been banned in many countries. Recent reports have highlighted the urgent need for biocompatible design of meshes for a safe and effective treatment in the long term. This study reports the design and evaluation of a novel, elastin based degradable mesh using an ovine model of POP as a potential surgical treatment. Elastin is a protein component of the ECM and provides elasticity to tissues throughout the body. Tropoelastin, the monomer subunit of elastin, has been used with success in electrospun constructs as it is a naturally cell interactive polymer. Biomaterials that incorporate tropoelastin support cell attachment and proliferation, and have been proven to encourage elastogenesis and angiogenesis in vitro and in vivo. The biological properties of tropoelastin were combined with the physical properties of PCL, a degradable synthetic polymer, with the aim of producing, characterizing and assessing the performance of continuous tropoelastin:PCL electrospun yarns. Using a modified spinneret electrospinning system and adjusting settings based on relative humidity, four blends of tropoelastin:PCL yarns were fabricated with concentration ratios of 75:25, 50:50, 25:75 and 0:100. Yarns were assessed for ease of manufacture, fibrous architecture, protein/polymer content, yarn stability - including initial tropoelastin release, mechanical strength, and ability to support cell growth. Based on overall favorable properties, a mesh woven from the 50:50 tropoelastin:PCL yarn was implanted into the vagina of a parous ewe with vaginal wall weakness as a model of pelvic organ prolapse. This mesh showed excellent integration with new collagen deposition by SEM and a predominant M2 macrophage response with few pro-inflammatory M1 macrophages after 30 days. The woven tropoelastin:PCL electrospun mesh shows potential as an alternative to non-degradable, synthetic pelvic organ prolapse mesh products.

Dataset Information

Tension-free vaginal mesh for patients with pelvic organ prolapse: mid-term functional outcomes.

Objective

Methods

Results

Conclusion

Publications

Tension-free vaginal mesh for patients with pelvic organ prolapse: mid-term functional outcomes.

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