Enhancing Participation of Older Women in Surgical Trials

Older participants are often excluded from clinical trials, precluding a representative sample

Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy

The purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy. This is a retrospective cohort study of women who underwent MISC between November 2004 and January 2009. Demographics, operative techniques, and outcomes were abstracted from medical records. Multivariable regression identified odds of erosion. Of 188 MISC procedures 19(10%) had erosions. Erosion was higher in those with total vaginal hysterectomy (TVH) compared to both post-hysterectomy (23% vs. 5%, p = 0.003) and supracervical hysterectomy (SCH) (23% vs. 5%, p = 0.109) groups. In multivariable regression, the odds of erosion for TVH was 5.67 (95% CI: 1.88–17.10) compared to post-hysterectomy. Smoking, the use of collagen-coated mesh, transvaginal dissection, and mesh attachment transvaginally were no longer significant in the multivariable regression model. Based on this study, surgeons should consider supracervical hysterectomy over total vaginal hysterectomy as the procedure of choice in association with MISC unless removal of the cervix is otherwise indicated

A pilot study comparing anatomic failure after sacrocolpopexy with absorbable or permanent sutures for vaginal mesh attachment.

ObjectivesTo describe anatomic failure rates for sacrocolpopexy in groups receiving either delayed absorbable or permanent monofilament suture for mesh attachment to the vagina.MethodsWe reviewed the medical records of 193 women who underwent sacrocolpopexy with 2 different types of sutures attaching polypropylene mesh to the vagina: delayed absorbable sutures (median follow-up, 43 weeks) and permanent sutures (median follow-up, 106 weeks). Vaginal apical failure was defined as Point C greater than or equal to half of the total vaginal length. Anterior-posterior compartmental failures were defined as Point Ba and/or Point Bp more than 0 cm. Fisher exact and χ2 tests were used to compare failure rates. There were no documented suture erosions in the delayed absorbable monofilament suture group during the review period. Two patients in the permanent suture group were found to have permanent suture in the bladder more than 30 weeks after the index procedure.ResultsFailure rates for the 45 subjects in the delayed absorbable group and 148 subjects in the permanent suture group were similar (4.4% vs 3.4%, p = 0.74) and not statistically different in any compartment: apical (0% vs 1.4%, p = 0.43), anterior (4.4% vs 2%, p = 0.38), or posterior (0% vs 1.4%, p = 0.43).ConclusionsDelayed absorbable monofilament suture appears to be a reasonable alternative to permanent suture for mesh attachment to the vagina during sacrocolpopexy. The use of delayed absorbable suture could potentially prevent complications of suture erosion into the bladder or vagina remote from the time of surgery

A pilot study comparing anatomic failure after sacrocolpopexy with absorbable or permanent sutures for vaginal mesh attachment.

ObjectivesTo describe anatomic failure rates for sacrocolpopexy in groups receiving either delayed absorbable or permanent monofilament suture for mesh attachment to the vagina.MethodsWe reviewed the medical records of 193 women who underwent sacrocolpopexy with 2 different types of sutures attaching polypropylene mesh to the vagina: delayed absorbable sutures (median follow-up, 43 weeks) and permanent sutures (median follow-up, 106 weeks). Vaginal apical failure was defined as Point C greater than or equal to half of the total vaginal length. Anterior-posterior compartmental failures were defined as Point Ba and/or Point Bp more than 0 cm. Fisher exact and χ2 tests were used to compare failure rates. There were no documented suture erosions in the delayed absorbable monofilament suture group during the review period. Two patients in the permanent suture group were found to have permanent suture in the bladder more than 30 weeks after the index procedure.ResultsFailure rates for the 45 subjects in the delayed absorbable group and 148 subjects in the permanent suture group were similar (4.4% vs 3.4%, p = 0.74) and not statistically different in any compartment: apical (0% vs 1.4%, p = 0.43), anterior (4.4% vs 2%, p = 0.38), or posterior (0% vs 1.4%, p = 0.43).ConclusionsDelayed absorbable monofilament suture appears to be a reasonable alternative to permanent suture for mesh attachment to the vagina during sacrocolpopexy. The use of delayed absorbable suture could potentially prevent complications of suture erosion into the bladder or vagina remote from the time of surgery

Measuring the impact of a posterior compartment procedure on symptoms of obstructed defecation and posterior vaginal compartment anatomy.

Introduction and hypothesisWe hypothesized that there would be a significant difference in changes in obstructed defecation symptoms and posterior compartment prolapse between women who underwent posterior vaginal wall prolapse repair (PR) and those who did not.MethodsThis was a two-site prospective cohort study of women undergoing prolapse or incontinence surgery in which a PR was, or was not, performed at the discretion of the surgeon. Women were assessed using validated obstructed defecation questionnaires and standardized examination measures (including POP-Q, measurement of transverse gh, and assessment for a rectovaginal pocket and laxity) prior to pelvic surgery and 12 weeks after surgery.ResultsOf 68 women who underwent surgery, 43 had PR. The PR group had higher obstructed defecation symptoms and greater posterior compartment prolapse at baseline. At 12 weeks, obstructed defecation symptoms had improved significantly more in the PR group than in the no PR group (all p < 0.03). Anatomic outcomes showed greater improvement in point Bp in the PR group (-3.4 vs. -0.7 no PR, p < 0.001) and resolution of the rectovaginal pocket (86 % vs. 42 %, p = 0.002). There were no significant changes in obstructed defecation symptoms or anatomic outcomes from baseline in the no PR group, while the PR group showed significantly improved obstructed defecation symptoms and anatomic outcomes after repair (p < 0.001 for both).ConclusionsSignificant improvements in obstructed defecation symptoms and posterior compartment prolapse were seen after PR, but not in women who did not receive PR. Obstructed defecation symptoms, Bp and rectovaginal pocket were the measures best able to demonstrate improvement after PR. We recommend the use of these measures to assess the impact of surgery in the posterior compartment

A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy.

Introduction and hypothesisWe investigated the efficiency and efficacy of vaginal mesh attachment using interrupted, non-barbed, delayed absorbable sutures in comparison with a running, barbed, delayed absorbable suture during laparoscopic sacrocolpopexy (LSC) and robotic sacrocolpopexy (RSC).MethodsWomen undergoing LSC or RSC were recruited. Participants were randomized to at least six 0 PDS non-barbed interrupted sutures or at least six passes of a 1 PDS barbed suture (Quill™) on each anterior and posterior polypropylene mesh leaflet. The primary outcome was the time to attach the mesh to the vagina. The LSC and RSC groups were block randomized by suture type. Secondary outcomes included: (1) intraoperative surgeon assessment of satisfaction as measured using a 10-cm visual analog scale (VAS), (2) postoperative POP-Q evaluation for anatomic failure, and (3) overall appearance of vaginal walls measured using a VAS.ResultsOf the 64 included subjects who were randomized, 32 had mesh attachment with the barbed suture (16 LSC, 16 RSC) and 32 had attachment with non-barbed sutures (16 LSC, 16 RSC). Among all the subjects (LSC and RSC), the non-barbed suture group had significantly longer mesh attachment times than the barbed suture group (42 vs. 29 min, p < 0.001). The non-barbed suture group had significantly better scores for intraoperative ease of suture placement, surgeon satisfaction with mesh appearance, and global satisfaction. At 12 months, there were no significant differences in anatomic failure between the suture groups or overall appearance of the vaginal walls (p > 0.05).ConclusionsThe barbed suture technique was 11 - 16 min faster for attaching mesh to the vagina than the non-barbed suture technique. Anatomic outcomes at 12 months were comparable between the suture groups. It is reasonable to use a running, barbed suture in minimally invasive sacrocolpopexy

A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy.

Introduction and hypothesisWe investigated the efficiency and efficacy of vaginal mesh attachment using interrupted, non-barbed, delayed absorbable sutures in comparison with a running, barbed, delayed absorbable suture during laparoscopic sacrocolpopexy (LSC) and robotic sacrocolpopexy (RSC).MethodsWomen undergoing LSC or RSC were recruited. Participants were randomized to at least six 0 PDS non-barbed interrupted sutures or at least six passes of a 1 PDS barbed suture (Quill™) on each anterior and posterior polypropylene mesh leaflet. The primary outcome was the time to attach the mesh to the vagina. The LSC and RSC groups were block randomized by suture type. Secondary outcomes included: (1) intraoperative surgeon assessment of satisfaction as measured using a 10-cm visual analog scale (VAS), (2) postoperative POP-Q evaluation for anatomic failure, and (3) overall appearance of vaginal walls measured using a VAS.ResultsOf the 64 included subjects who were randomized, 32 had mesh attachment with the barbed suture (16 LSC, 16 RSC) and 32 had attachment with non-barbed sutures (16 LSC, 16 RSC). Among all the subjects (LSC and RSC), the non-barbed suture group had significantly longer mesh attachment times than the barbed suture group (42 vs. 29 min, p < 0.001). The non-barbed suture group had significantly better scores for intraoperative ease of suture placement, surgeon satisfaction with mesh appearance, and global satisfaction. At 12 months, there were no significant differences in anatomic failure between the suture groups or overall appearance of the vaginal walls (p > 0.05).ConclusionsThe barbed suture technique was 11 - 16 min faster for attaching mesh to the vagina than the non-barbed suture technique. Anatomic outcomes at 12 months were comparable between the suture groups. It is reasonable to use a running, barbed suture in minimally invasive sacrocolpopexy

Proregenerative extracellular matrix hydrogel mitigates pathological alterations of pelvic skeletal muscles after birth injury

Pelvic floor disorders, including pelvic organ prolapse and urinary and fecal incontinence, affect millions of women globally and represent a major public health concern. Pelvic floor muscle (PFM) dysfunction has been identified as one of the leading risk factors for the development of these morbid conditions. Childbirth, specifically vaginal delivery, has been recognized as the most important potentially modifiable risk factor for PFM injury; however, the precise mechanisms of PFM dysfunction after parturition remain elusive. In this study, we demonstrated that PFMs exhibit atrophy and fibrosis in parous women with symptomatic pelvic organ prolapse. These pathological alterations were recapitulated in a preclinical rat model of simulated birth injury (SBI). The transcriptional signature of PFMs after injury demonstrated an impairment in muscle anabolism, persistent expression of genes that promote extracellular matrix (ECM) deposition, and a sustained inflammatory response. We also evaluated the administration of acellular injectable skeletal muscle ECM hydrogel for the prevention of these pathological alterations. Treatment of PFMs with the ECM hydrogel either at the time of birth injury or 4 weeks after injury mitigated PFM atrophy and fibrosis. By evaluating gene expression, we demonstrated that these changes are mainly driven by the hydrogel-induced enhancement of endogenous myogenesis, ECM remodeling, and modulation of the immune response. This work furthers our understanding of PFM birth injury and demonstrates proof of concept for future investigations of proregenerative biomaterial approaches for the treatment of injured pelvic soft tissues