A major concern associated with the use of biomaterials in pelvic reconstructive surgery involves fear of adverse effects on sexual function.1 Despite the already widespread use of synthetical mesh and biological grafts in pelvic organ prolapse surgery, it remains largely unknown whether, and to what extent, sexual dysfunction relates to these procedures.2 Studies on traditional prolapse repair often suggest that sexual function deteriorates after surgery, with dyspareunia occurring in as much as one third of patients after posterior repair.3–5 Others suggest that traditional prolapse repair may actually improve sexual function.6–9 Recent trials using porcine dermal grafts in pelvic reconstructive surgery indicate that postoperative dyspareunia is less common,10 or comparable to,11,12 traditional suture repair. Biological grafts are, however, degradable, and concerns of unsatisfying durability have been raised.11–13
Macroporous polypropylene mesh is associated with long-term durability, beneficial tensiometric properties, and proven biocompatibility when used in stress urinary incontinence surgery.14,15 This is the underlying rationale for the current marketing of polypropylene mesh for pelvic organ prolapse surgery. However, when increasing the biomaterial load and changing the tensile properties of the mesh by increasing the surface size and adding fixation points, mesh contraction (often referred to as shrinking), erosion, and stiffness of the vagina are side effects that may have a detrimental effect on sexual function. The present multicenter cohort study aims to prospectively estimate sexual function before and 1 year after pelvic organ prolapse surgery using a trocar-guided transvaginal polypropylene mesh kit.
MATERIALS AND METHODS
Data for this study were obtained from sexually active women participating in a prospective multicenter study on the use of transvaginal mesh for symptomatic pelvic organ prolapse repair.16 Patients were recruited at 26 centers in Sweden, Denmark, Finland, and Norway during an inclusion period encompassing June 2006 through March 2007. All gynecologists participating in the trial were experienced pelvic surgeons and had pretrial, supervised, hands-on training in operating room sessions using a standardized trocar-guided transvaginal mesh technique (Prolift, Ethicon, Somerville, NJ). The compartment-specific surgical techniques have been described previously in detail.17 In the anterior vaginal compartment, the uniformly sized and shaped polypropylene mesh is passed through the obturator foramen and arcus tendineus fascia pelvis using four trocar-guided extension arms. In the posterior compartment, the mesh is placed through a transgluteal approach and the two trocar-guided extension arms are passed through the sacrospinous ligaments.
Before undergoing pelvic organ prolapse surgery, all patients underwent a physical examination, including a gynecological examination in the supine position, using the Pelvic Organ Prolapse Quantification system. Methods, definitions, and descriptions conformed to the standards recommended by the International Continence Society. Postoperative prolapse stage 0–I was considered anatomical cure. Baseline patient characteristics, demographic data, medical history, and surgical data were collected using a separate questionnaire. Subjective outcomes with regard to pelvic organ function and surgical results have been reported elsewhere.16 Criteria for inclusion included fluency in the respective country’s language, Pelvic Organ Prolapse Quantification stage II or higher, symptoms specifically attributed to pelvic organ prolapse including vaginal bulging, pelvic heaviness, or vaginal protrusion. All patients had to be able to make an informed consent to participate and had to be physically and mentally able to participate in follow-up. Exclusion criteria included any previous pelvic organ cancer, severe rheumatic disease requiring oral steroid treatment, systemic connective tissue disorders, and patients physically or mentally unable to participate in follow-up or give informed consent to participate in the study.
Patients completed the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) before and 1 year after surgery. The validated PISQ-12 is a condition-specific, 12-item questionnaire on sexual function, with ordinal response alternatives based on a 5-point Likert scale.18 The PISQ-12 correlates well with other sexual health questionnaires and has shown sensitivity to change after pelvic reconstructive surgery and predictability of scores using the unabridged PISQ (31 items). The specific questions can be combined to form a score where higher scores indicate better sexual function. The maximum PISQ-12 score is 48, and, for the purposes of this study, a score in the lowest quartile (score less than 12) was considered poor sexual function.
All trial protocols were submitted to the clinical research unit at the Department of Obstetrics and Gynecology, Danderyd University Hospital, Stockholm, Sweden, and only the principal investigators had access to the data. The transvaginal mesh manufacturing company had no influence over study aim, design, or execution or analysis and interpretation of data. The corresponding author guarantees the integrity of the data, drafted the article, and had the final responsibility for the decision to submit for publication. The study was approved by the appropriate research ethics committees in the participating countries.
Data on patient characteristics are presented as frequencies (%). Results from the summated PISQ-12 questionnaire are presented as calculated scores as described in detail previously. Analysis of specific questions and PISQ-12 scores was performed using Wilcoxon signed rank test for dependent samples. Potential predictors of low sexual function scores were analyzed using a forward multivariable logistic regression model assessing the effect of age, body mass index, current cigarette smoking, menopausal status, childbirths, anatomical failure, and concurrent surgery. Results from the risk analysis are presented as relative risks with 95% confidence intervals. All analyses were performed using Statistica software (Statistica, Tulsa, OK), and a P<0.05 was considered significant for all analyses.
A total of 261 patients were included in the cohort study,16 of whom 232 participated in the 1-year assessment. Preoperatively, 105 of 261 patients (40%) acknowledged being sexually active, 133 of 261 patients (51%) reported no sexual activity, and 23 of 261 patients (9%) did not respond to the sexual function questionnaire. At the 1-year follow-up, 84 of 232 patients (36%) reported sexual activity and responded to the questionnaire, whereas 45 of 232 patients (19%) did not respond to the questionnaire. Women who were not sexually active were older (69.0±4.2 standard deviation) than those who were sexually active (61.5±7.6 standard deviation), but other baseline characteristics were similar between participants and nonparticipants. Table 1 summarizes patient characteristics.
Scores from PISQ-12 could be calculated for 93 of 105 patients preoperatively and for 69 of 84 patients postoperatively. There was an overall significant decrease in average PISQ-scores when comparing preoperative with 1-year postoperative values (Table 2). The trend toward postoperatively decreasing PISQ-scores was consistently observed also when stratifying the cohort for age at surgery, concurrent surgery, body mass index, parity, menopausal status, and smoking (Table 2).
Anatomical success 1 year after surgery was not associated with noticeably improved PISQ-12 scores compared with anatomical failure, regardless of vaginal compartment (Table 2). Also, when comparing the different transvaginal mesh techniques, there was little difference between the techniques (Table 2), and the trend toward worsening sexual function scores was evident for all three surgical procedures.
Intraindividual comparisons on preoperative and postoperative PISQ-12 scores were available for 56 patients who responded to all questions on both occasions. Preoperatively, 26 (46%) women reported what we classified as low sexual function scores (ie, PISQ-12 mean score 12 or less), whereas 29 (54%) women had scores of more than 12. Age at surgery and other characteristics were similar in women with scores of 12 or less when compared with those with scores of more than 12. In women with low preoperative PISQ-12 scores, six participants (23%) moved to having scores of more than 12 one year after surgery. In women with preoperative scores of more than 12, 13 (45%) had low scores postoperatively. When tried in a forward multiple logistic regression analysis, we found no significant predictors of low (12 or less) sexual function scores for age older than 65 years (relative risk 1.5, 95% confidence interval 0.3–7.4), body mass index higher than 25 (2.1, 0.5–8.9) (body mass index is calculated as weight (kg)/[height m]2), current cigarette smokers (8.9, 0.7–107.2), postmenopausal status (3.3, 0.1–86.2), more than two childbirths (0.7, 0.3–1.5), stage II or higher anterior prolapse postoperatively (1.1, 0.6–2.0), stage II or higher posterior prolapse postoperatively (1.1, 0.7–6.9), other concurrent surgery (1.9, 0.8–7.3), and vaginal erosion when characterized as present or absent (2.9, 0.8–9.1).
When breaking down the PISQ-12 questionnaire into specific questions, postoperative improvements were observed in two physical items: 1) always fear of incontinence restricting sexual activity (82% compared with 63%, P<.01), and 2) always avoidance of intercourse because of vaginal bulging (70% compared with 29%, P<.001). Incontinence during sexual activity (62% compared with 56%, P=.37) and pain at intercourse (dyspareunia) showed no significant changes postoperatively (P=.62 for anterior and P=.13 for posterior mesh repair). Detailed results for dyspareunia are shown in Figure 1A and B. Although generally nonsignificant by themselves, there was an overall postoperative worsening of all behavioral–emotive and partner-related items, including never sexual desire (1% compared with 4%, P=.62), never orgasm with their partners at intercourse (6% compared with 6%, P=.84), never sexually excited (1% compared with 4%, P=.17), never satisfied with sexual variety (5% compared with 7%, P=.11), always negative emotional reactions when having sex (60% compared with 72%, P=.004), partner inability to have an erection (50% compared with 72%, P=.05), and premature ejaculation (53% compared with 63%, P=.06).
Sexual function scores deteriorate in women 1 year after trocar-guided transvaginal mesh surgery. However, contrary to common belief, the worsening was attributed to decreased scores in behavioral–emotive and partner-related items. For specific symptoms reflecting physical function, including dyspareunia, overall scores neither improved nor worsened.
The lack of clinical safety and efficacy data for surgical procedures using biomaterials has been a source of controversy.19,20 Although much-wanted clinical data are becoming available gradually, many important outcome measures remain largely unknown. Presumed adverse effects on sexual function often are promoted as an important reason to avoid the use of permanent biomaterials in pelvic organ prolapse surgery.20 Indeed, increasing the size and biomaterial load of the mesh may render widely used synthetic materials, such as macroporous monofilament polypropylene mesh, new properties when compared with using the mesh for the tension-free vaginal tape procedure. Thus, the generally positive effects on sexual function associated with the use of polypropylene mesh in stress urinary incontinence surgery21 cannot be assumed to also apply to pelvic organ prolapse surgery.
In the present study, the overall worsening in sexual function when comparing preoperative and 1-year postoperative PISQ-12 scores was consistent in all strata of study participants. The negative outcome was apparent also when comparing the pelvic compartment–specific procedures. It is, however, somewhat difficult to interpret the clinical relevance and importance of an approximately 15% reduction in sexual function scores when the observed preoperative sexual function scores in our cohort were quite low already at baseline. Because there are no epidemiological studies assessing sexual function using the PISQ in a representative background population, our baseline findings cannot be related to normative values for this age group. Our data are in concurrence with several previous studies suggesting that pelvic organ prolapse has a negative effect on sexuality and sexual function,7,22,23 but, in comparison with the preoperative PISQ-12 scores from a French study on prolapse surgery,24 it seems that our study population started off with rather feeble sexual health and that surgery did not improve it for either patients or spouses.
A certain degree of selection bias could be involved in the surgical decision making of the present study because the effects of transvaginal mesh surgery on sexual function were entirely unknown when the study was initiated. Fewer than half of the patients included in the original cohort were sexually active at the start, and it is plausible that those sexually active women who were selected for the study acknowledged poor sexual function preoperatively. Nearly a quarter of women with poor sexual function before surgery moved in a positive direction, whereas nearly half of women with better than poor sexual function worsened.
We were unable to detect any specific predictors of poor sexual function postoperatively and recognize that this could be an effect of our study population not being adequately powered for this specific task. The inclusion and exclusion criteria add to the internal validity of our findings, but, considering the population characteristics, one should bear in mind that our outcomes may not be generalizable to nulliparous or premenopausal women. Further studies are therefore necessary to identify specific phenotypes at risk for a deterioration of sexual function after transvaginal prolapse surgery.
Anatomical success of transvaginal mesh repair showed little coherence with sexual function scores, and PISQ-12 scores were similar in patients with postoperative prolapse stage 0–I when compared with stage II–III. In a predominantly parous and postmenopausal population, stage 0 may be considered a surgical overcorrection of vaginal anatomy. Anatomical overcorrection and tautness of the mesh may compromise vaginal elasticity, give rise to vaginal tension, and prevent swelling of the vagina at sexual arousal. On the other extreme, a surgical failure has not provided the intended support and has done little to relieve the mechanical symptoms while adding a surgical trauma. Contrary to some studies,5,24,25 our data indicate that objective success in terms of anatomical restoration of pelvic organ support has little to do with improved sexual function in general. Also, after vaginal surgery for pelvic organ prolapse without mesh, sexual function scores have been unrelated to anatomical and functional improvements.26 Considering the very low rate of incontinence surgery performed in the study, improvements in sexual function due to a corresponding improvement in continence status could not have occurred.
To our surprise, we found that the deterioration in overall sexual function scores after surgery could be attributed almost entirely to a worsening in behavioral–emotive and partner-related aspects, rather than in physical function as was expected. In concurrence with Sentilhes et al,24 we found that pain at intercourse was actually less common 1 year after surgery using nonabsorbable polypropylene mesh when compared with the preoperative assessment. Tension-free positioning of the central part of the mesh and leaving the extension arms in place without fixation are integral parts of the trocar-guided transvaginal mesh technique. This may have contributed to the prevention of unwanted mesh tension and subsequent dyspareunia in the present study. Our results should, however, be interpreted with some caution because findings on dyspareunia were statistically nonsignificant and our results diverge from a prospective study using a similar trocar-guided mesh kit where de novo dyspareunia was observed in nearly 13% of the patients.27 The same study reported improvements in dyspareunia in seven of eight patients with preoperative complaints. The discrepancy between our studies is difficult to explain but possibly could be related to inherent differences in surgical techniques as well as mesh composition and texture. One needs also to consider as a limitation that one fifth of the patients did not respond to the questionnaire 1 year after surgery. How this affected our analysis and the reasons for their “withdrawal” from this substudy are sources of conjecture.
The psychological mechanisms and pathways involved in sexual arousal and female sexual emotions are complicated. Studies show that women who are satisfied with their body image and self esteem report more sexual activity, more frequent orgasms, and comfort with having sex with the light on compared with those who are not satisfied with their body image and self esteem.28 Even though women seeking urogynecologic care often score low in sexual–emotional areas such as sexual desire, arousal, orgasm, lubrication, and satisfaction,29,30 studies focusing on self image and the emotional aspects of sexual function after vaginal surgery are scarce.25,31 The consequences of vaginal surgery on behavioral–emotive and partner-related sexual function are therefore poorly understood. It is a limitation of our study that we did not collect information from partners, and future investigations on why partners experience diminished sexual function after vaginal surgery would add valuable understanding to this field.
It is noteworthy that, although the aforementioned studies have reported an overall improvement in sexual function scores after traditional surgery, the relative improvement was pronounced for physical function but that the behavioral–emotive items were not improved to the same extent.7,31 The risk for sexual dysfunction should be considered after pelvic surgery also when using new surgical techniques with satisfactory anatomical and pelvic organ function outcomes.16 Although many clinicians focus on the risk for palpable physical sequela after urogynecologic surgery, current evidence suggests that emotional and partner-related implications of having undergone vaginal surgery need to be considered to at least the same extent as dyspareunia.
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