Biomechanical properties of prolapsed vaginal tissue in pre- and postmenopausal women

The aim of this study was to explore the relationship between biomechanical properties and the occurrence of pelvic organ prolapse (POP) through analysis on biomechanical properties of vaginal tissue. The biopsy specimens were obtained from 43 patients undergoing transvaginal hysterectomy, who were assigned into premenopausal POP, postmenopausal POP, premenopausal control and postmenopausal control groups. Tissue specimens were biomechanically assessed by a purpose-built tissue puller system, and stress–strain curves were digitally recorded. The Young’s modulus, Poisson’s ratio, maximum elongation, maximum fracture of vaginal tissue were 9.45 ± 0.70, 0.43 ± 0.01, 1.50 ± 0.02, 0.60 ± 0.02 in premenopausal POP group; 12.10 ± 1.10, 0.39 ± 0.01, 1.14 ± 0.05, 0.27 ± 0.03 in postmenopausal POP group; 6.65 ± 1.48, 0.46 ± 0.01, 1.68 ± 0.11, 0.79 ± 0.05 in premenopausal control group and 10.26 ± 1.10, 0.42 ± 0.01, 1.37 ± 0.04, 0.42 ± 0.03 in postmenopausal control group. There was significant difference in biomechanical properties between premenopausal POP group and premenopausal control group (p < 0.01). There was significant difference in biomechanical properties between postmenopausal POP group and postmenopausal control group (p < 0.01). Biomechanical properties in POP group were significantly lower than that in control group, suggesting that degeneration of biomechanical properties in pelvic support construction might lead to the occurrence of POP. Grant Fujian Science & Technology Bureau Foundation No. 2000I1003.     

Biomechanical properties of vaginal tissue: preliminary results

The aim of this study is to characterise the biomechanical properties of vaginal tissue to develop an accurate cure of pelvic organ prolapse (POP). Prolapsed vaginal tissues were extracted during the prolapse cure of five patients (POP) and on five cadavers without noticed pelvic floor dysfunction (non-pelvic organ prolapse) with agreement of the ethics committee. Uni-axial tension was performed, and the results were analysed. Individual reproducibility of experimental results was good, and the results highlight the non-linear relationship between stress (force per unit of surface) and strain (l − l ₀ / l ₀) and very large deformation before rupture appearance. This experimental study has proven for the first time that the mechanical behaviour of vaginal tissue has to be defined as hyperelastic with a large deformation. This response has to be taken into account to develop accurate synthetic prostheses for POP cure and in the numerical simulation of the pelvic floor. The authors thank the Foundation for Medical Research for financing this study and the ethics committee for their approval.     

Biomechanical properties of vaginal tissue. Part 1: new experimental protocol

PURPOSE: We established a reliable experimental protocol to characterize the biomechanical properties of vaginal tissue and guarantee good test repeatability. MATERIALS AND METHODS: Because of the large quantities of tissue required to establish the protocol, we worked on ewes according to animal ethics laws. To study the mechanical properties of ewe vaginal tissue we used unidirectional tension tests at a constant deformation rate. Rupture tests were performed under different experimental conditions to analyze the influence of each condition. RESULTS: Tissue underwent exhaustive tests. The parameters studied were sampling, freezing, preservation conditions, hygrometry and temperature during vaginal tissue tests, and the rate of deformation during tests. As previously noted, vaginal tissue is anisotropic and the collection has been tested previously. We noted that freezing tissue had no consequences on the mechanical response of tissue during unidirectional tension testing. The experimental conditions that we defined (temperature, hygrometry and rate of deformation) allowed us to have reproducible tests. CONCLUSIONS: Results and analyses allowed us to determine the best reference protocol.     

Effect of vaginal infiltration with ornipressin or saline on intraoperative blood loss during vaginal prolapse surgery: a randomised controlled trial

Introduction and hypothesis

Hydrodissection incorporating different types of vasoconstrictors is commonly used in vaginal prolapse surgery. There is little evidence as to whether it adds clinical value or whether it exposes the patient to unnecessary risk. The aim of this study was to compare the effect of a vasoconstrictor compared with saline alone on operative blood loss and cardiovascular parameters in a randomised clinical trial setting.

Methods

Patients undergoing vaginal prolapse surgery were randomised to an ornipressin (Por-8, Ferring) solution or saline alone for hydrodissection. The surgeon and patient were blinded to the solution used. Operative blood loss was accurately quantified and blood pressure and pulse readings recorded Pre, intra- and postoperatively.

Results

Eighty women were randomised. There was a statistically significant difference in the median blood loss: 35 ml (1-209 ml) in the ornipressin group compared with 81 ml (2-328 ml) in the saline group, p?=?0.03. There was no statistically significant difference in the median pre and postoperative blood pressure or pulse rate between groups.

Conclusions

The use of a vasoconstrictor (ornipressin) resulted in a statistically significant decrease in operative blood loss during vaginal prolapse surgery. This occurred without any significant changes in measured cardiovascular parameters.

     

Biomechanical properties of skin during tissue expansion for breast-reconstructive surgery

Mammary reconstruction following mastectomy involves breast augmentation, which probably sets the skin under tension. This aspect of mechanobiology has rarely been explored in an objective way. The aim of the present study was to measure the biomechanical properties of skin using a suction method. Eight sites of the thorax were assessed in 26 cases of mastectomy performed in 20 women aged 49+/-7 years. In order to distinguish the effects of breast augmentation from forces exerted by earth gravitation, measurements were performed in standing and lying down positions, both before and after breast augmentation of about 450 ml.     

Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial

Introduction and hypothesis

Our aim was to evaluate clinically relevant long-term outcomes of transvaginal mesh or native tissue repair in women with recurrent pelvic organ prolapse (POP).

Methods

We performed a 7-year follow-up of a randomized controlled trial on trocar-guided mesh placement or native tissue repair in women with recurrent POP. Primary outcome was composite success, defined as absence of POP beyond the hymen, absence of bulge symptoms, and absence of retreatment for POP. Secondary outcomes were adverse events, pain, and dyspareunia. Multiple imputation was used for missing data of composite success and pain; estimates are presented with 95% confidence intervals (CI).

Results

Between August 2006 and July 2008, 194 women were randomized; 190 underwent surgery. At 7 years, 142 (75%) were available for analysis, of whom, the primary outcome could be calculated in 127. Composite success was 53% (95% CI 41, 66) for mesh and 54% (95% CI 42, 65) for native tissue. Repeat surgery for POP was 25% for mesh and 16% for native tissue (difference 9%; 95% CI ?5, 23) and occurred in untreated compartments in the mesh group and treated compartments in the native tissue group. Mesh exposure rate was 42%; pain with mesh 39% and native tissue 50% (difference?? 11%, 95% CI ?27, 6); dyspareunia with mesh 20% and native tissue 17% (difference 3%, 95% CI ?9, 17).

Conclusions

Seven-year composite success rates appeared similar for mesh and native tissue. Mesh did not reduce long-term repeat surgery rates due to de novo POP in nonmesh-treated vaginal compartments. Mesh exposure rates were high, though significant differences in pain and dyspareunia were not detected. Clinical trial registration. ClinicalTrials.gov, NCT00372190.

     

Prospective observational study of the impact of vaginal surgery (pelvic organ prolapse with or without urinary incontinence) on female sexual function

Introduction and hypothesis

There is a difference of opinion in the literature as to whether pelvic organ prolapse (POP) is a direct cause of female sexual dysfunction (FSD). Sexual function in women is negatively impacted by the presence of urinary symptoms. Thus, sexual dysfunction (SD) might be improved, unchanged, or worsened by pelvic floor surgery.

Methods

In this study, we observed SD and impact of surgical intervention on female sexual function (FSF) using a validated Prolapse/Urinary Incontinence Sexual Questionnaire Short Form (PISQ-12) in women undergoing surgery for POP with or without urinary incontinence. Two hundred women were recruited and followed up at 6 and 12 months postoperatively.

Results

Sexual function (SF) as measured by the PISQ-12 improved after surgery irrespective of the nature of surgery or the patient’s past gynaecology history. Improvement in SF was seen by 6 months (97 patients) postsurgery (P < 0.05), after which (at 12 months; 80 patients) no further change was observed. Improved SF was associated with better patient satisfaction postoperatively.

Conclusions

Sexual function improved in women following surgery for POP with or withour urinary incontinence, irrespective of the nature of surgery and the patient’s past gynecologic history. Results of this study will assist when counselling women with POP with or without urinary incontinence regarding treatment options.

     

Vaginal surgery for genital prolapse: long-term results in 218 cases

Summary The aim was to assess the long-term results of vaginal surgery on pelvic support defects and continence by a prospective study of 218 patients operated on between 1982 and 1992. The mean age was 66 years. Half had stress incontinence of urine (SIU) associated with prolapse, which extended outside the introitus in 78% of cases. The procedure included vaginal hysterectomy, tightening of the round and sacrouterine ligaments, suspension of the bladderneck by the Bologna procedure and myorrhaphy of the levator muscles. The mean follow-up was 69 months. Thirty-two patients (15%) had recurrent pelvic relaxation, in 84% of these there was vaginal vault prolapse with enterocele. Recurrence was commoner in cases of urge incontinence or pauciparity. Postoperative SIU occurred in 29 patients with previous SIU (27%) and in 10 without (9%). The recurrence of SIU was commoner when there was sphincter incompetence or SIU grade 2 or 3. The Bologna procedure allows good correction of SIU. Its combination with vaginal hysterectomy, tightening of the uterine ligaments and myorrhaphy of the levators provides a complete treatment for genital prolapse by the vaginal route. So as not to reduce the size of the vagina, the operation should be reserved for major cystocele or for patients beyond sexual activity.     

Uterus-sparing vaginal surgery of genitourinary prolapse employing biocompatible material

OBJECTIVE: The study presents an original uterus sparing technique for transvaginal repair of total genitourinary prolapse. The technique employs a synthetic mesh of mixed polypropylene and 910 polyglactin fibers. METHODS: The prosthesis creates a support for the cystocele, the cervix and the enterocele. It has four anchoring sites: two at the rear in the sacrospinous ligaments and two at the front in the arcus tendineous of the levator ani muscle. Between February 2001 and December 2004, 24 patients (mean age 66.9 years), presenting symptoms of uterine prolapse, cystocele and enterocele (POP-Q stage III-IV Aa associated to II-III-IV C), were treated with our procedure. Pre- and postoperative parameters were evaluated statistically. RESULTS: No patient had any serious complications. The mean follow-up was 31.1 months (range 6-52). 19 patients (79.1%) have shown excellent results and have been completely cured. In 5 other cases (20.8%), the cystocele was completely cured and there was a significant improvement in the hysterocele and the enterocele. One patient required surgical treatment for postoperative stress incontinence. Statistical analysis of data regarding the pre- and postoperative prolapse stage demonstrated a high degree of objective cure rates (p < 0.0001). CONCLUSIONS: While hysterectomy remains the habitual treatment for severe uterine prolapse, our technique provides a promising alternative solution. It is also significant that there were no complications of erosion or infection associated with the prosthesis.     

Long-term outcomes of vaginal mesh versus native tissue repair for anterior vaginal wall prolapse

Introduction and hypothesis

To estimate the risk of repeat surgery for recurrent prolapse or mesh removal after vaginal mesh versus native tissue repair for anterior vaginal wall prolapse.

Methods

We utilized longitudinal, adjudicated, healthcare claims from 2005 to 2010 to identify women ≥18 years who underwent an anterior colporrhaphy (CPT 57420) with or without concurrent vaginal mesh (CPT 57267). The primary outcome was repeat surgery for anterior or apical prolapse or for mesh removal/revision; these outcomes were also analyzed separately. We utilized Kaplan–Meier curves to estimate the cumulative risk of each outcome after vaginal mesh versus native tissue repair. Cox proportional hazards models were used to estimate the hazard ratio (HR) for vaginal mesh versus native tissue repair, adjusted for age, concurrent hysterectomy, and concurrent or recent sling.

Results

We identified 27,809 anterior prolapse surgeries with 49,658 person-years of follow-up. Of those, 6,871 (24.7%) included vaginal mesh. The 5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh versus native tissue (15.2 % vs 9.8 %, p?<0.0001) with a 5-year risk of mesh revision/removal of 5.9%. The 5-year risk of surgery for recurrent prolapse was similar between vaginal mesh and native tissue groups (10.4 % vs 9.3 %, p?=?0.70. The results of the adjusted Cox model were similar (HR 0.93, 95%CI: 0.83, 1.05).

Conclusions

The use of mesh for anterior prolapse was associated with an increased risk of any repeat surgery, which was driven by surgery for mesh removal. Native tissue and vaginal mesh surgery had similar 5-year risks for surgery for recurrent prolapse.     

Synthetic graft use in vaginal prolapse surgery: objective and subjective outcomes

Introduction and hypothesis

This study reports 1-year outcomes in women who underwent transvaginal pelvic organ prolapse (POP) surgery with Prolift^® transvaginal mesh.

Methods

Pre- and postoperative objective vaginal Pelvic Organ Prolapse Quantification (POP-Q) and subjective symptom and impact assessments (Pelvic Floor Distress Inventory (PFDI)-20 and Pelvic Floor Impact Questionnaire (PFIQ)-7, respectively) were performed. Postoperative vaginal tenderness, stricture, and patient satisfaction were also obtained. Paired t tests were utilized for analysis.

Results

Mean age was 61.8?±?9.8 years; mean follow-up interval was 425.0?±?80.0 days (range, 237–717). POP-Q measurements of Ba, Bp, and C were significantly improved (all p values?p values?≤?0.004). Thirty-five of 48 (73%) were completely satisfied, and two (4%) were not satisfied. Complications (n (percent)) included graft exposure (1 (2%)), dyspareunia (2 (4%)), and granulation tissue (3 (6%)).

Conclusions

Women undergoing transvaginal repair of POP with the Prolift^® mesh system showed significant improvement in 1-year anatomic and subjective measures.     

Quality of life after surgery for genital prolapse in elderly women: obliterative and reconstructive surgery

The objective of this study was to determine if obliterative and reconstructive vaginal surgery for advanced pelvic organ prolapse improve quality of life in elderly women. Women age 65 years or older with stage 3 or 4 pelvic organ prolapse who desired surgical correction were prospectively enrolled. The subjects underwent either obliterative or reconstructive vaginal surgery based on their personal preference and sexual expectations. The subjects received a pelvic organ prolapse quantitation examination and completed the pelvic floor distress inventory (PFDI), the pelvic floor impact questionnaire (PFIQ), the SF-36, and the Beck depression inventory preoperatively, 6 and 12 months after surgery. Seventy-nine subjects were enrolled, 70 of whom completed follow-up: 30 in the obliterative group and 40 in the reconstructive group. Both groups demonstrated significant improvements in the pelvic organ prolapse, urinary, and colorectal scales of the PFDI and PFIQ 6 and 12 months after surgery with no differences between the two treatment groups. In addition, there were significant and clinically important improvements noted in the bodily pain, vitality, social functioning, role–emotional, and mental health summary scales of the SF-36 in both groups after surgery, with no significant difference between groups. In appropriately selected elderly women, both obliterative and reconstructive vaginal surgery for advanced pelvic organ prolapse significantly improved health-related quality of life.     

Sedation and local anaesthesia for vaginal pelvic floor repair of genital prolapse using mesh

In this study of the surgical repair of pelvic organ prolapse (POP), the vaginal pelvic floor repair with mesh (PFR-Mesh) procedure was used. The procedure is originally named TVM. All 55 patients in the series were operated upon under sedation and local anaesthesia as pain relief. The objectives were twofold. Firstly, the objective was to evaluate peri-operative and immediate post-operative complications. Secondly, the objective was to evaluate the feasibility of performing these relatively complex procedures under sedation and local anaesthesia. The visual analogue scale (VAS) was used to record pain during and after the operations. At a follow-up visit 8–12 weeks post-operatively, a self-instructed questionnaire evaluating subjective opinions of the operation itself and the post-operative period was handed in. Of the 55 patients, anterior, posterior and total PFR-Mesh procedures were performed in 39 (71%), 12 (22%) and 4 (7%) patients, respectively. Mean age was 68 years (52–93). All patients could be operated as scheduled under sedation and local anaesthesia. Mean operative time was 38 min (26–70). Peri-operative complications consisted of two cases of bladder perforation with the superior needle in an anterior repair and vaginal perforation with the inferior needle also in an anterior repair. At the conclusion of the operation VAS was recorded to be 0–3 in 65% of the patients. There were no immediate post-operative complications. Out of 55 patients, 35 (64%) left the ward on the day of operation whilst the remaining 20 (36%) patients stayed for only one night. The safety of the PFR-Mesh procedure and the feasibility of performing these procedures under sedation and local anaesthesia were demonstrated. However, expertise in vaginal surgery is required.     

Role of concurrent vaginal hysterectomy in the outcomes of mesh-based vaginal pelvic organ prolapse surgery

Introduction and hypothesis

Hysterectomy is often performed at the time of pelvic organ prolapse (POP) surgery; yet, there is insufficient evidence regarding the specific effect of hysterectomy on outcomes. We sought to determine the outcomes and associated short-term complications of mesh-based POP surgery with and without concurrent hysterectomy.

Methods

We utilized the New York Statewide Planning and Research Cooperation System (SPARCS) database to identify patients under 55 years of age undergoing surgeries for POP with mesh between 2009 and 2014. Patients who had a hysterectomy at the time of mesh-based POP surgery were compared with those who underwent mesh-based POP surgery without hysterectomy. Outcome measures of the patient groups before and after propensity score matching were compared. We assessed the difference Chi-squared tests and log-rank tests in the entire cohort and Mantel–Haenszel stratified Chi-squared tests and Prentice-Wilcoxon tests in the matched cohort.

Results

A total of 1,601 women underwent mesh-based POP surgery. 921 patients underwent concurrent hysterectomy, whereas 680 had mesh-based uterine-preserving POP surgery. After propensity score matching, there was no difference in reintervention rates between groups for up to 3 years. Concurrent hysterectomy with mesh-based POP repair was consistently associated with longer hospitalization (20.0% vs 12.8% stayed longer than 2 days) and higher charges (median charges were $22,689 vs $19,273).

Conclusions

Concurrent hysterectomy during mesh-based POP surgery in patients under 55 years led to more expensive charges and a longer stay compared with uterine-preserving mesh surgery. There was no difference in reintervention rates between groups for up to 3 years.