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ORIGINAL RESEARCH |
From the 1Department of Obstetrics and Gynecology, Rijnstate Hospital, Arnhem, the Netherlands; 2Department of Obstetrics and Gynecology, Radboud University Medical Centre Nijmegen, Nijmegen, the Netherlands; 3Department of Rheumatology, Radboud University Medical Centre Nijmegen, Nijmegen, the Netherlands; 4Department of Neurology, Rijnstate Hospital, Arnhem, the Netherlands; and 5Department of Epidemiology and Biostatistics, University Medical Centre Nijmegen, Nijmegen, the Netherlands.
| ABSTRACT |
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METHODS: Relevant patient characteristics were extracted retrospectively from the medical records of 155 women aged 40 years or younger who had received surgical treatment for vulvar vestibulitis syndrome. To assess outcome and complications, 126 of these 155 women (81%) participated in a telephone interview, conducted 1 to 4 years after surgery.
RESULTS: After surgery 93% of the patients could have sexual intercourse compared with 78% before surgery; this increase was statistically significant (Mantel-Haenszel odds ratio 3.43, 95% confidence interval [CI] 1.487.96). In 62% of the women (95% CI 5370%), sexual intercourse was painless after surgery. Eighty-nine percent (95% CI 8495%) would recommend surgical treatment to other women experiencing vulvar vestibulitis syndrome. There were no major complications. Decreased lubrication during sexual arousal was the most frequently reported adverse effect (24%, 95% CI 1632%), followed by the development of a Bartholins cyst (6%, 95% CI 210%). More of the women aged 30 years or younger reported that they could have sexual intercourse after surgery, and more of them would recommend surgical treatment to other patients than women aged 31 years or older.
CONCLUSION: Surgical treatment for vulvar vestibulitis syndrome achieved high success rates with an acceptable rate of complications. Age of 30 years or younger was associated with a better outcome.
LEVEL OF EVIDENCE: III
| MATERIALS AND METHODS |
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One gynecologist (J.M.J.D.) diagnosed all the patients based on Friedrichs criteria. These criteria were found to be reliable by Bergeron et al.21 All the patients had complaints of superficial dyspareunia, pain during the cotton-swab pressure test on the vestibular side of the hymenal base (cotton-swab test), and had no signs of other vulvar or vaginal disease. Surgery was performed by the same gynecologist (J.M.J.D.) on all the patients under general anesthesia in an outpatient or short admission setting. Although no predesigned protocol was in place, all patients underwent the same procedure, consisting of vestibulectomy and advancement plasty, as described by Nichols and Randall.22 In this procedure, shown in Figure 1, the hymen was removed completely, together with the full thickness of skin on the adjacent vestibulum, using Harts line and the fourchette as boundaries. When preoperative cotton-swab testing was positive in the paraurethral area, excision was extended to include this region. The defect was covered by vaginal wall after undermining and advancement. Approximation to the surrounding skin was realized with interrupted 30 polyglactin sutures. Follow-up was conducted by the same gynecologist (J.M.J.D.) at 6 and 12 weeks after surgery. If wound healing was sufficient after 6 weeks, the patients started vaginal dilation exercises with a mold and were encouraged to start or resume sexual intercourse. After another 6 weeks, an evaluation was made by telephone to check for unforeseen problems or complications. If there were any problems, new follow-up appointments were made.
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Medical history and relevant patient characteristics were extracted retrospectively from the medical files and noted on a chart abstraction form. Relevant patient characteristics were age, date of surgery, duration of symptoms before intake, primary or secondary dyspareunia, capacity to have sexual intercourse before surgery, pain during activities other than sexual intercourse, history of sexual abuse, child bearing, treatment for vulvar vestibulitis syndrome other than surgery, paraurethral extension of vulvar vestibulitis syndrome, and capacity to undergo vaginal examination before surgery. Information was also collected on the histopathologic diagnosis made in the excised tissue.
Eligible patients were sent a letter, including a stamped, addressed return envelope, to inform them about this follow-up study and to invite them to take part in a telephone interview. They were promised that their identity would be kept secret. In the letter the possibility to refuse participation without consequences for further treatment was offered. All women participating in the study gave informed consent, either in writing or orally, before starting the interview. The women who showed interest and those who did not respond within 1 month were approached by phone. Interviews were conducted by 2 female medical students (M.B. and A.W.P.vH.) and consisted of answering 5 short questions (box).
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Based on the questions in the telephone interview, the following 4 outcome measures of surgical treatment were made: sexual intercourse possible, sexual intercourse painless, a satisfactory sexual life, and a positive recommendation of surgery. The variable, "intercourse painless," is an important outcome motivating this study. Literature showed that the probability of "intercourse painless" was 0.6. Furthermore, a difference in the probability of "intercourse painless" between 2 groups of a patient characteristic (ie, 2 age groups) of 2025% is considered clinical relevant. A power analysis showed that a Fisher exact test with a 0.05 2-tailed significance level will have 81% power to detect the difference between a group 1 proportion of 0.475 and a group 2 proportion of 0.725 (that would refer to an odds ratio of 2.38) when the sample size in each group is 70. Data were analyzed in the software program SPSS (SPSS Inc., Chicago, IL). Multivariate logistic regression analysis was used to test differences in each of the outcome measures between groups, with specific patient characteristics adjusted for time to follow-up. The dependent variable was the outcome measure and the independent variables were the patient characteristic and the time to follow-up (months). The odds ratios adjusted for time to follow-up with 95% CIs are presented. The increase in intercourse possible after surgery compared with before surgery was tested for statistical significance using the method of Mantel-Haenszel for paired designs.23 The appropriate odds ratio with 95% confidence interval (CI) is presented.
| RESULTS |
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Table 1 presents the outcomes of surgical treatment derived from answers by the participants. Pain was the only reason sexual intercourse was impossible after surgery. The answers showed that 93% of the women (95% CI 8998%) could have sexual intercourse and 62% (95% CI 5370%) did not suffer from pain.
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Table 2 presents the complications of surgical treatment reported by the participants. In 77 of the 126 women (61%, 95% CI 5270%) there had been no complications after surgery. The most frequently reported complication was decreased lubrication during sexual arousal (24%, 95% CI 1632%). All the women had been informed about the risk of adverse effects preoperatively. In 8 patients (6%, 95% CI 210%) a Bartholins cyst developed. Other complications were infrequent.
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Patient characteristics are shown in Table 3. Before surgery 78% of the women could have sexual intercourse. Relations between patient characteristics and the outcome of surgical treatment are presented in Table 4. Differences in the number of positive outcomes between groups of patients with specific characteristics are presented as odds ratios (ORs) adjusted for time to follow-up. The ORs that reached statistical significance are indicated in the table. After surgery more women could have sexual intercourse than before (OR 3.43, 95% CI 1.487.96). More of the women aged 30 years or younger reported that they could have sexual intercourse after surgery (OR 8.20, 95% CI 1.5443.73), and more of them would recommend surgical treatment to other patients (OR 4.74, 95% CI 1.4215.82) than women aged 31 years or older. There was a negative association between the need for nonsurgical treatment other than standard vaginal dilation exercises after surgery and outcome. Women with pain when wearing tight pants before surgery reported less often that intercourse had become painless afterward and women with a history of sexual abuse reported less often that intercourse was possible after surgery than women without such a history. There was a positive association between a histopathologic diagnosis of moderate to severe inflammation and a positive recommendation of surgery to other women. Time to follow-up did not confound the relation between any of the patient characteristics and any of the outcome measures, and the ORs adjusted for time to follow-up were very similar to the crude ORs. Outcome of surgery was not influenced by parity, primary or secondary vulvar vestibulitis syndrome, capability to have sexual intercourse before surgery, or previous nonsurgical treatment.
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| DISCUSSION |
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Our simple telephone interview consisted of asking short, nonvalidated questions, most of which could be answered with yes or no. We did not gather more detailed information structurally, such as whether sexual intercourse had become less painful after surgery. Other aspects that we did not incorporate were the outcomes of the 29 nonresponders and comparisons of treatment methods other than surgery. In a small randomized controlled trial of 14 patients, Weijmar Schultz et al20 reported no difference in outcome between behavioral therapy preceded by surgery or behavioral therapy alone. Bergeron et al17 randomly assigned 87 women to either cognitivebehavioral therapy, electromyographic biofeedback, or vestibulectomy and reported that vestibulectomy was significantly more successful in reducing pain but that the 3 treatments were equally effective in improvement of psychological adjustment and sexual function.
In our study complications mainly developed in the longer term. The most frequently reported complication was diminished lubrication, but it was not considered to be a problem by most of the women, because they were able to manage adequately with artificial lubricants. The percentage of women who developed a Bartholins cyst was the same as that reported in a study by Peters.24 These 2 complications are probably the result of removal of the vestibulum and covering the defect, which caused obstruction of Bartholins ducts.
Owing to the invasive nature of surgical treatment and the risk of complications, it is important to formulate strict selection criteria. Selection should ideally be based on patient characteristics that are known to influence the outcome. However, at present little is known about such prognostic factors. Therefore, we aimed to relate patient characteristics to the outcome of surgery as a preliminary step to identify relevant issues. Age at the time of surgery proved to be the most important variable, because the results were better in young patients. Instead of withholding surgery, young women especially should be offered this therapeutic option. The negative association between outcome and the need for postoperative conservative treatment indicated that these women were probably still experiencing vulvar vestibulitis syndrome. Pain when wearing tight pants and a history of sexual abuse were also negatively associated with outcome. Perhaps the women with these characteristics were suffering from more than just vulvar vestibulitis syndrome and surgical treatment was not the right therapy for them. A histopathologic diagnosis of moderate to severe inflammation was positively associated with outcome. This could be used as a prognostic variable by taking biopsies from all of the patients preoperatively. However, we would not recommend taking biopsies as a standard procedure until further studies have been done, because we only found an association between focal inflammation and 1 of the 4 outcome measures and because histopathology does not form part of the diagnostic process in vulvar vestibulitis syndrome.22
Based on the results of this study, we conclude that surgical treatment deserves a role in the management of vulvar vestibulitis syndrome. In view of the small risk of surgical complications, it can be presented as a realistic option after failed nonsurgical treatment, especially in young women. Patients should be well informed about the risks involved with this therapy, and candidates should be selected according to strict criteria. To be able to offer optimal individualized treatment for vulvar vestibular syndrome, more studies are needed with prospective controlled designs.
| Footnotes |
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doi:10.1097/01.AOG.0000195058.91506.ae
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