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Obstetrics & Gynecology:
doi: 10.1097/AOG.0b013e3182932ce2
Original Research

Vaginal Dilators for Prevention of Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial

Antosh, Danielle D. MD; Gutman, Robert E. MD; Park, Amy J. MD; Sokol, Andrew I. MD; Peterson, Joanna L. RN; Kingsberg, Sheryl A. PhD; Iglesia, Cheryl B. MD

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Author Information

Department of Obstetrics and Gynecology, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, Washington, DC; and the Departments of Reproductive Biology and Psychiatry, Division of Behavioral Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio.

Corresponding author: Danielle D. Antosh, MD, The Methodist Hospital; Center for Restorative Pelvic Medicine; 6560 Fannin, Suite 2100, Houston, TX 77030; e-mail: ddantosh@tmhs.org.

Funded by the American Congress of Obstetricians and Gynecologists Boehringer Ingelheim Pharmaceuticals Inc Research Award in Female Sexual Dysfunction.

Financial Disclosure Dr. Kingsberg is a consultant for BioSante, NorvoNordisk, Pfizer, Viveve, Trimel, Palatin, Sprout, and Shinogi. The other authors did not report any potential conflicts of interest.

Presented at the American Urogynecologic Society 33rd Annual Scientific Meeting, October 3–6, 2012, Chicago, Illinois.

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Abstract

OBJECTIVE: To compare rates of de novo dyspareunia in women with and without vaginal dilator use after posterior colporrhaphy.

METHODS: This randomized controlled trial included sexually active patients with prolapse and no bothersome baseline dyspareunia undergoing posterior colporrhaphy. Patients were randomized to daily vaginal dilator use from postoperative weeks 4 through 8 or to no dilator use. Pelvic organ prolapse quantification examination and vaginal caliber were measured at baseline, 8 weeks, and 6 months postoperatively. Sexual function was evaluated at baseline, 3 months, and 6 months postoperatively using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12. Participants completed a Patient Global Impression of Improvement at 3 months and 6 months postoperatively.

RESULTS: Sixty patients were randomized: 30 in the dilator group and 30 in the control group. There were no differences in baseline characteristics and postoperative vaginal caliber between groups. At 3 months, 9.5% of patients reported de novo dyspareunia in the dilator group compared with 19.2% of control patients (P=.44). At 6 months, 12.5% of patients in the dilator group reported de novo dyspareunia compared with 3.8% of control patients (P=.34). There was a 13% loss-to-follow-up rate, and therefore we did not meet appropriate power to detect a difference. There were no differences in overall sexual function or Patient Global Impression of Improvement scores between groups at 3 months and 6 months.

CONCLUSION: There were no significant differences in de novo dyspareunia rates, overall postoperative sexual function scores, or global improvement scores between those using vaginal dilators compared with control patients.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01299363.

LEVEL OF EVIDENCE: I

Pelvic organ prolapse and rectoceles are common conditions that adversely affect quality of life in women.1 Although vaginal pelvic reconstructive surgery may fix anatomical defects, these procedures can negatively affect sexual function by causing de novo dyspareunia. Women usually have either unchanged or improved sexual function after pelvic reconstructive surgery.2–5 However, de novo dyspareunia may occur as a result of scarring or compromise to the vascular and nerve supply of the vagina and perineum.6,7 Specifically, posterior colporrhaphy has been implicated as the most likely cause of postoperative dyspareunia as a result of vaginal narrowing or creation of a scarred ridge in the posterior vaginal wall.4,8 Rates of de novo dyspareunia after posterior colporrhaphy range from 8% to 26%.4,9–12

Vaginal dilators have been used to treat women with dyspareunia. A previous nonsurgical study discovered that 78% of women had resolution of dyspareunia with outpatient self vaginal dilator use.13 Vaginal dilators may improve dyspareunia by stretching the levator ani muscles to prevent muscle contraction as well as by softening or preventing scar tissue formation. Although vaginal dilators improve dyspareunia, it is unclear whether they can be safely used during the early postoperative recovery period to prevent de novo dyspareunia. Patients can control the degree of pressure placed on the healing vagina using a small dilator to decrease muscle tension and gradually stretch and soften the underlying scar tissue. The primary aim of this study was to determine whether vaginal dilator use after posterior colporrhaphy decreases the risk of postoperative dyspareunia.

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MATERIALS AND METHODS

This single-center randomized controlled trial was approved by the MedStar Health Research Institute and MedStar Washington Hospital Center institutional review board, and Consolidated Standards of Reporting Trials guidelines were followed. All women who presented with a rectocele were approached for recruitment after they made the decision to undergo reconstructive pelvic surgery with a concomitant posterior colporrhaphy from November 2010 to February 2012. We included women who were at least 18 years old, English-speaking, sexually active in the past 6 months with heterosexual vaginal intercourse, available for 6-month follow-up, and able to complete study questionnaires and use vaginal dilators. Women were excluded from trial participation for the following reasons: 1) significant baseline dyspareunia determined by the response “usually” or “always” to question 5 on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-1214: “Do you feel pain with sexual intercourse”; 2) pregnancy; 3) prior pelvic radiation therapy; 4) active vaginal infection or herpes; 5) posterior colporrhaphy was not performed at the time of surgery; or 6) postoperative wound complication such as a rectovaginal hematoma, mesh erosion, or vaginal wound infection at the 2-week postoperative randomization visit. All participants signed a written informed consent before their prolapse surgery.

Participants underwent a standardized preoperative history including demographics, comorbidities, and prior pelvic surgery. Comorbidities included stroke, cardiac events, hypertension, diabetes, hyperlipidemia, asthma, chronic pulmonary disease, pain disorder, peptic ulcer disease, recurrent urinary tract infections, immunosuppressive disease, depression, and breast cancer. The physical examination included a pelvic organ prolapse quantification (POP-Q) examination. Participants also completed a validated baseline Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 and a 7-day diary of sexual intercourse from the prior week. Each question on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 has five possible responses including “never,” “seldom,” “sometimes,” “usually,” and “always.” Overall higher scores indicate better sexual function.

Four fellowship-trained pelvic reconstructive surgeons performed the surgeries with the assistance of fellows and residents. Patients underwent their scheduled prolapse surgery with a posterior colporrhaphy performed using the standard or traditional technique, a site-specific technique, or a combination of both. Posterior colporrhaphy was performed with a midline posterior vaginal wall incision followed by dissecting the vaginal epithelium away from the rectovaginal muscularis until the levator ani muscles were reached laterally and the perineal body inferiorly. Traditional posterior colporrhaphy involved midline plication of the rectovaginal muscularis without levator muscle plication. Site-specific repair involved identifying defects in the fibromuscular layer during rectal examination and reapproximating those defects with interrupted sutures. Posterior colporrhaphy was either performed with or without a concomitant perineorrhaphy reapproximating bulbocavernosus and transverse perineal muscles. Vaginal caliber was measured preoperatively once general anesthesia was obtained and again after the posterior colporrhaphy was performed. Caliber was measured using a ring pessary set, from size 1 to 7, with caliber determined by the largest ring beneath the pubic symphysis to the posterior fornix. Patients underwent concomitant multicompartment prolapse and incontinence repairs as indicated and intraoperative complications were recorded.

At the 2-week postoperative visit, patients were randomized to vaginal dilators or no vaginal dilators in a 1:1 ratio by the statistician using a computer-generated randomization schedule. Group assignments were sealed in consecutively numbered, sealed, opaque envelopes. After confirming that there were no wound complications on the 2-week postoperative examination, the surgeon notified the research nurse to open the envelope for group assignments. Because of the nature of the study, it was not possible to blind patients or surgeons to the intervention. Patients in the dilator group were given an extra small-sized vaginal dilator and printed instructions at the 2-week visit (Fig. 1). They were instructed to begin vaginal softening exercises with the dilator from 4–8 weeks postoperatively. The vaginal softening exercises involved gently massaging the posterior wall of the vagina with the dilator and lubricating jelly for 5–10 minutes daily. Patients in both groups were instructed to refrain from sexual intercourse for the first 8 weeks after surgery. After the 8-week examination, women in both groups were allowed to resume sexual intercourse. Those in the dilator group had the option of continued dilator use if desired. Postoperative POP-Q examination and vaginal caliber were performed at 8 weeks and 6 months. Complications such as urinary tract infection, seroma or hematoma, ileus or bowel obstruction, fistula, nerve injuries, blood transfusion, mesh erosion, or other unspecified complications were assessed at each visit. Those in the dilator group were given a 7-day diary for compliance of dilator use during the week before the 8-week visit and 3-month questionnaires. Postoperative study questionnaires included the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 and the Patient Global Impression of Improvement for prolapse, which were mailed to patients in both groups at 3 months and again at the final 6-month postoperative visit.15 Patient Global Impression of Improvement is scored with lower scores indicating better improvement.

Vaginal dilator.Fig....
Vaginal dilator.Fig....
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The primary aim of the study was to compare the rates of de novo dyspareunia in women with and without vaginal dilator use 3 months and 6 months after posterior colporrhaphy. De novo dyspareunia was defined as the response of “usually” or “always” on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 question 5 postoperatively in a woman who answered “never,” “seldom,” or “sometimes” on the baseline questionnaire. The secondary aims of the study were to evaluate the change in sexual function using the overall Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 score before and after surgery, to evaluate patient satisfaction using Patient Global Impression of Improvement scores, and to determine the effect of vaginal caliber and POP-Q measurements on sexual function after surgery. We hypothesized that daily use of vaginal dilators after posterior colporrhaphy would reduce the rate of de novo dyspareunia at 3 months and 6 months.

Assuming an α of 0.05, a sample size of 27 in each group provides an 80% power to detect a difference in the ordinal response to the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 concerning pain during sex between groups if the probability that a response in one group is less than a response in the other group is 0.72, based on a two-sided Mann-Whitney test. We assumed there would be a 10% dropout rate; therefore, we enrolled 60 patients total in the study, 30 in each group.

SPSS for Windows 17 was used for data management and statistical analysis. Because the data had statistically nonnormal distributions, nonparametric statistical methods were used for analysis. The dilator and control groups were compared with respect to noncategorical variables using the Mann-Whitney test and with respect to percentages using the χ2 of association or Fisher’s exact test. Fisher’s exact test was done when the expected frequencies were too small to permit use of the χ2. The Friedman test was used to compare different time points with respect to noncategorical variables. A .05 significance level was used for all statistical tests. No one-sided tests were done.

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RESULTS

Sixty-eight women were enrolled into the study and 60 were randomized. Of these participants, 30 were allocated to vaginal dilators and 30 were in the control group without dilators. Three-month data were available for 51 of 60 (85%) of patients and 6-month data were available for 52 of 60 (87%). Allocation and follow-up are presented in Figure 2. Two women were not sexually active during the 6-month postoperative period, and they did not complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 postoperatively.

Enrollment and dispo...
Enrollment and dispo...
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Baseline characteristics are summarized in Table 1. The mean age of participants was 53.9 years in the dilator group and 51.8 years in the control group (P=.65). There were no differences in comorbidities between groups (all P>.05). Women in the dilator and control groups did not significantly differ in menopausal status, marital status, parity, body mass index, prior pelvic surgery, and vaginal caliber or POP-Q stage. The mean number of days patients had sexual intercourse preoperatively over a 1-week period was 1.2 (standard deviation [SD] 1.3) and 1.4 (SD 1.3) in dilator and control groups, respectively. Operative data, including type of posterior colporrhaphy performed, concomitant procedures, and intraoperative complications, are displayed in Table 2. Of the posterior colporrhaphies in the dilator and control groups, respectively, 80% and 90% were performed with the traditional technique, 6.7% and 3.3% were site-specific, and 10% and 6.7% were a combination of traditional and site-specific. There was no difference in the type of suture used for posterior colporrhaphy between groups with surgeons most frequently using both polydioxanone and polyglactin 910 sutures. Perineorrhaphy was performed with the posterior colporrhaphy in 83.3% and 86.7% of patients in the dilator and control groups, respectively. There were no significant differences between groups in concomitant procedures such as a hysterectomy, apical suspensions, anterior colporrhaphy, and slings or for intraoperative complications. The only intraoperative complication was cystotomy, which occurred in 6.7% and 3.3% of patients in the dilator and control groups, respectively, during concomitant slings or bladder dissections. No participants received posterior vaginal mesh for prolapse.

Table 1
Table 1
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Table 2
Table 2
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Postoperatively, de novo dyspareunia occurred in 9.5% (two of 21) of women in the dilator group compared with 19.2% (five of 26) in the control group at 3 months (P=.44). At the 6-month postoperative visit, 12.5% (three of 24) in the dilator group and 3.8% (one of 26) in the control group had de novo dyspareunia (P=.34). Postoperative Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 sexual function scores, Patient Global Impression of Improvement scores, and POP-Q measurements are listed in Table 3. There were no differences in total Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 scores between groups at 3 months or 6 months. However, there was a significant increase in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 total score from baseline to 3 months for the control group (P=.005) but no significant change in score for the dilator group at 3 months (P=.35). There was no significant improvement in total Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 score from baseline to 6 months in either group, indicating overall sexual function was unchanged (P=.12 and P=.28). Global satisfaction at 6 months on Patient Global Impression of Improvement scores was better with a lower mean score in the dilator group compared with control participants (mean 1.4, SD 0.5 compared with mean 1.7, SD 0.7, P=.057); however, this did not reach statistical significance. There was a statistically significant decrease in the POP-Q stage from baseline to 6 months for both the dilator group (P<.001) and the no-dilator group (P<.001).

Table 3-a Preoperati...
Table 3-a Preoperati...
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Patients in the dilator group appeared to be compliant with vaginal softening exercises. Seventy percent (21 of 30) of women in the dilator group at the 8-week visit reported using the dilator with the mean number of days the dilator was used on the 7-day diary being 5.0 (SD 2.3). At 3 months postoperatively, the mean number of days the vaginal dilator was used was 6.2 (SD 2.6) days with only 30% (nine of 30) patients continuing use of dilators. Vaginal caliber measurements are listed in Table 3. In both the dilator and control groups, vaginal caliber decreased significantly from baseline to 6 months after posterior colporrhaphy (P=.001 and P=.002). However, there were no statistically significant differences in vaginal caliber between the dilator group and the control group at 8 weeks or 6 months postoperatively. No statistically significant Spearman correlations were found between postoperative Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 sexual function scores and postoperative vaginal caliber, overall POP-Q stage, genital hiatus measurements, and POP-Q posterior vaginal wall measurements (point Bp). Only two patients two of 52 (3.8%) had a stage II rectocele at 6 months, and both of these patients were in the control group. Both patients were asymptomatic and did not require treatment.

Table 3-b Preoperati...
Table 3-b Preoperati...
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There were no significant differences in postoperative complications (Table 4). Mesh exposure only occurred in one patient in the dilator group. This patient had an anterior mesh colpopexy repair with the Uphold device. Her mesh exposure was diagnosed at the 8-week postoperative visit and was excised in the office.

Table 4
Table 4
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DISCUSSION

In this study, de novo dyspareunia rates were similar between patients assigned to postoperative vaginal softening exercises with vaginal dilators and patients who did not use dilators. There was a nonsignificant trend to higher overall patient satisfaction for patients assigned to dilator use at study completion. Overall sexual function improved only in the control group at 3 months, but this returned to baseline at 6 months. A possible explanation for the higher satisfaction scores in the dilator group is that patients were playing an active role in their postoperative recovery and sexual function. The vaginal dilators may serve as a behavioral therapy tool to decrease anticipatory anxiety of penetration with sexual intercourse. However, patient satisfaction and Patient Global Impression of Improvement scores are not specific to sexual function and may have been influenced by other factors as well. De novo dyspareunia scores were not significantly different between patients in the dilator group compared with control participants, and this may have been the result of our sample size during follow-up visits and our very low rates of dyspareunia. Thirteen percent of patients did not follow up and two of the patients who did follow up chose not to be sexually active at all postoperatively, which reduces the power to determine our primary outcome. Based on our study, the use of vaginal dilators actively involves patients in their recovery and appears to be safe but does not decrease the risk of postoperative dyspareunia. At our center we are not recommending routine postoperative vaginal dilator use after posterior colporrhaphy.

Vaginal dilators have multiple applications in gynecology. They are used for prevention and treatment of sexual dysfunction from pelvic radiotherapy, for dyspareunia and vaginismus, and for women with vaginal agenesis.13,16–18 Vaginal dilator therapy after pelvic reconstructive surgery is a novel use. In our study, dilators were used for vaginal softening and to massage scar tissue with vaginal softening to prevent potential dyspareunia. Although dilator use did not prevent postoperative dyspareunia in the present study, surgeons may consider instituting this therapy if patients report dyspareunia postoperatively. Vaginal dilator use appears to be safe if instituted 4 weeks postoperatively.

In our study, overall sexual function after posterior colporrhaphy remained unchanged from baseline at 6 months. Prior studies evaluating sexual function after prolapse repair either report unchanged or improved sexual function postoperatively, but some with high rates of dyspareunia.2–5,19 A study by Paraiso et al compared posterior colporrhaphy using three techniques (traditional, site-specific, and graft-augmented) and found an overall improvement in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 sexual function scores 1 year postoperatively but with dyspareunia rates ranging from 14% to 20% in traditional and site-specific repair groups.3 We did not see an improvement in total Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 scores, and this is likely the result of the younger mean age of our patient population with higher baseline preoperative sexual function scores. Two other randomized studies on posterior colporrhaphy report a postoperative dyspareunia rate of 7–42%.20,21 The de novo dyspareunia rates in our study are relatively low comparatively; however, the definitions of dyspareunia and the outcome measures used varied among studies.

The major strength of this study is that it is a randomized controlled trial that used validated outcome measures and sexual function assessment scales. It is a novel idea given the paucity of studies investigating preventative measures for dyspareunia after pelvic reconstructive surgery. This study was also able to assess sexual function in the standard postoperative period and long term at 6 months. One limitation of this trial includes our sample size, which did not meet appropriate power as a result of the lost to follow-up rate. Furthermore, some patients were not sexually active after surgery as a result of partner-related issues. However, the difference in dyspareunia rates at 6 months was small and unlikely to be significant if those additional patients had returned. Another limitation is that concomitant procedures were performed, which may have positively or negatively affected sexual function and dyspareunia rates. One final limitation is that the patients who chose to enroll in the study may have inherently been more motivated and open about their sexuality compared with patients undergoing pelvic reconstructive surgery who declined; thus, the results may not be generalizable.

In conclusion, no significant differences were seen in de novo dyspareunia or overall postoperative sexual function scores between those using vaginal dilators compared with control participants at 3 months and 6 months postoperatively. Use of vaginal dilators may result in greater global improvement and patient satisfaction at 6 months; however, the extremely low 6-month dyspareunia rate in both the dilator group (12%) and control participants (4%) in this study implies that a much larger randomized trial would be needed to determine the use of vaginal dilators after pelvic reconstructive surgery. A study of that magnitude would be impractical and not economically feasible.

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© 2013 The American College of Obstetricians and Gynecologists

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