Objective
Colpocleisis is a definitive surgical treatment for prolapse resulting in vaginal obliteration. We sought to evaluate body image, regret, satisfaction, and pelvic floor symptoms following this procedure.
Study Design
This was a prospective multicenter study through the Fellows’ Pelvic Research Network. All women electing colpocleisis for management of pelvic organ prolapse were screened for enrollment. The Pelvic Floor Impact Questionnaire, Pelvic Floor Distress Inventory, and the modified Body Image Scale (BIS) were completed preoperatively and 6 weeks following surgery. Additionally, the Decision Regret Scale and the Satisfaction with Decision Scale were administered at the 6-week postoperative visit. A sample size of 88 subjects was calculated to evaluate change in the BIS score.
Results
In all, 87 patients were analyzed. Mean age was 79 years (SD 5.8) with a mean body mass index of 27 (SD 5.3). The majority (89.3%) was Caucasian. Six weeks after surgery, significant improvements were noted in all parameters. Mean BIS scores decreased from 4.8 to 1.2 ( P < .001), signifying improved body image. Indeed, the overall number of subjects with BIS scores in the normal range doubled after surgery. Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire scores decreased significantly ( P < .001 and P < .001), suggesting a positive impact on bladder, bowel, and prolapse symptoms. Finally, low levels of regret (mean score 1.35) and concurrent high satisfaction (mean score 4.73) were documented.
Conclusion
Colpocleisis improves body image and pelvic floor symptoms while giving patients a definitive surgical option that results in low regret and high satisfaction.
US Census Bureau projections estimate that by the year 2030, >22% of US women will be aged ≥65 years with 3% being aged ≥85 years. This predicts marked increases from the current population of elderly women. Such a shift in demographics will be reflected in the utilization of health care for these individuals, particularly in the case of pelvic floor dysfunction. Given higher rates of these disorders in the elderly, studies suggest a 45% increase in demand for treatment of such complaints.
Colpocleisis has been used as an effective treatment for advanced pelvic organ prolapse since the 1800s and provides a surgical alternative to traditional reconstruction. This obliterative procedure offers a high success rate (90-100%) with low complication risks. However, due to alterations in normal female anatomy and the loss of future vaginal intercourse, providers may be reluctant to offer this option to their patients. While previous studies have shown quality of life (QOL) and pelvic floor symptoms improve following colpocleisis, there is little investigating its impact on body image, regret, or satisfaction.
Therefore, the primary aim of this study was to determine whether patients with pelvic organ prolapse who undergo colpocleisis have an improvement in body image following surgery. Our secondary aims were to assess decision regret and satisfaction with the decision to undergo this procedure using validated instruments.
Materials and Methods
This was a prospective cohort of women planning colpocleisis for the correction of pelvic organ prolapse. The study was performed through the Society of Gynecologic Surgeon’s Fellows’ Pelvic Research Network across 7 hospitals in the United States. Each site participates in the training and education of female pelvic medicine and reconstructive surgery fellows and independently obtained institutional review board approval. Subjects were eligible for participation if they elected colpocleisis for management of prolapse and were literate in English. Exclusion criteria included a mental status level that precluded the comprehension or completion of survey questionnaires or a previous diagnosis of dementia. Written informed consent was obtained from all participants.
Demographic information including age, self-assigned race, parity, medical and surgical histories, smoking status, and prior treatment for pelvic organ prolapse were collected. Physical examination data including height, weight, and Pelvic Organ Prolapse Quantification measurements were recorded. All participants completed preoperative questionnaires including: the Pelvic Floor Distress Inventory (PFDI), short form (PFDI-20) ; the Pelvic Floor Impact Questionnaire (PFIQ), short form (PFIQ-7) ; the modified Body Image Scale (BIS) ; and an individualized goal survey.
The PFDI is a short-form validated questionnaire consisting of 20 items. It can be further broken down into 3 subscales: the Pelvic Organ Prolapse Distress Inventory, the Colorectal-Anal Distress Inventory, and the Urinary Distress Inventory (UDI). Each subscale provides a measure of condition-specific QOL or distress. Higher scores indicate a greater degree of bother or distress.
The PFIQ is a validated questionnaire evaluating the impact of urinary, colorectal-anal, and pelvic organ prolapse symptoms on daily functioning. The subscales are made up of 7 items and include: the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. Higher scores represent more bother or a greater degree of impact on daily activities.
Body image was assessed using the modified BIS. This scale was modified by Jelovsek and Barber to make it appropriate for patients with pelvic organ prolapse. Example questions include: “Have you felt less physically attractive as a result of your vaginal prolapse?” This modified BIS consists of 8 questions evaluating the impact of prolapse on a patient’s body image. Items are scored 0 for responses of “not at all” through 4 for responses of “very much.” In general, higher scores indicate poor body image. The BIS has been interpreted by evaluating mean scores, total scores, and by a method described as dichotomization. With this technique, “responses of ‘not at all’ were considered normal and any response of ‘a little,’ ‘quite a bit,’ and ‘very much’ were considered abnormal.”
Preoperatively, subjects were asked to list a primary goal for their surgery. This was not multiple-choice or list-based, but instead allowed patients to use their own words to describe their desired outcome. These descriptions were then classified into categories by the investigators: “management or correction of prolapse or bulge,” “improvement in urinary or bladder symptoms,” or “increase the ability to perform daily activities.” All but 5 responses could be placed into 1 of these 3 categories.
Surgical data included concomitant procedures, type of anesthesia, estimated blood loss, length of surgery, preoperative and postoperative hemoglobin levels, and surgical complications. At the 6-week postoperative visit, participants were asked to complete the Decision Regret Scale (DRS)-Pelvic Floor Disorders (PFD), the Satisfaction with Decision Scale (SDS)-PFD, and a visual analog scale (VAS) in addition to the PFDI, PFIQ, and BIS.
Regret and satisfaction were assessed using a modified DRS and SDS, the DRS-PFD and the SDS-PFD. These have been validated in women undergoing surgery for pelvic floor dysfunction. The DRS-PFD is a 5-item questionnaire with 2 reverse scored questions. Each question is answered on a 5-point scale. Low mean scores represent low regret. The SDS-PFD is a 6-item tool also utilizing a 5-point scale. A mean score is established, and high scores signify high satisfaction with the decision to undergo surgery. Additionally, subjects reporting regret or dissatisfaction were encouraged to provide comments.
The VAS was conducted to specifically measure the subject’s satisfaction with their surgical outcome. The scale was 10 cm with 0 being “not satisfied” and 10 being “very satisfied.” Subjects were asked to mark the point on the line that represented their level of satisfaction with their surgical outcome.
Our sample size calculation revealed a total of 88 subjects were required to detect an effect size of 0.33 on the BIS before and after colpocleisis with an alpha error of 0.05, 90% power. This effect size was chosen using data from a previous study evaluating the effect of pelvic organ prolapse repair on body image and sexual function. Statistical analysis was performed using software (SPSS Statistics, version 19; IBM Corp, Armonk, NY). Descriptive data and frequencies were calculated and reported. As all data did not meet assumptions for normality, nonparametric tests, such as the related-samples Wilcoxon signed rank test and the Kruskal-Wallis test, were employed. The sample size calculation was conducted using software (nQuery Advisor, version 7.0; Statistical Solutions, Saugus, MA).
Results
Eighty-nine subjects were enrolled from March 2011 through October 2012. Of these, one cancelled her surgical procedure, and 1 did not proceed due to unrelated medical complications. Thus, 87 subjects were available for analysis. This represented recruitment from 7 sites located across the United States. The mean age was 79 years (SD 5.8) with a mean body mass index of 27 (SD 5.3). The majority (89.3%) was Caucasian, nonsmoking (96.4%), and had prolapse stage ≥3 (90%) ( Table 1 ). Only a small portion (14%) of subjects reported having a diagnosis of chronic obstructive pulmonary disease. Constipation was reported in 28% of subjects. Previous therapies for management of prolapse included pessary (70%), surgery (30%), and physical therapy (4%).
| Variable | Value |
|---|---|
| Age, y, mean (SD) | 79.4 (5.83) |
| Parity, median (IQR) | 3 (2–4) |
| BMI, mean (SD) | 27.1 (5.28) |
| Obesity category, n (%) | |
| Underweight (BMI <18.5) | 4 (4.8) |
| Normal weight (BMI 18.5-24.9) | 30 (35.7) |
| Overweight (BMI 25-29.9) | 31 (36.9) |
| Obese 1 (BMI 30-34.9) | 12 (14.3) |
| Obese 2 (BMI 35-39.9) | 7 (8.3) |
| Race, n (%) | |
| Caucasian | 75 (89.3) |
| African American | 3 (3.6) |
| Hispanic | 2 (2.4) |
| Asian | 2 (2.4) |
| Not specified | 2 (2.4) |
| Smoking status, n (%) | |
| Never | 62 (74.7) |
| Previous | 18 (21.7) |
| Current | 1 (1.2) |
| Not documented | 2 (2.4) |
| Preoperative prolapse stage | |
| 2 | 6 (9.8) |
| 3 | 36 (59.0) |
| 4 | 19 (31.1) |
| Medical history, n (%) | |
| Asthma/COPD/chronic bronchitis | 12 (14.5) |
| Chronic constipation | 23 (28.0) |
| Prior therapies for prolapse | 52 (61.9) |
| No previous treatment | 32 (38.1) |
| Physical therapy | 2 (3.8) |
| Pessary | 37 (71.1) |
| Estrogen for symptoms | 18 (34.6) |
| Prior surgery | 16 (30.8) |
Concurrently with colpocleisis, 9 vaginal hysterectomies and 36 antiincontinence procedures were performed ( Table 2 ). Anesthesia was most often general endotracheal intubation (75%). Average surgical duration was 99 minutes (SD 37). Postoperatively the mean hemoglobin was 11.1 g/dL (SD 3.8) with median estimated blood loss of 100 mL. Of surgeries, 78% were uncomplicated. The most common reported complication was discharge home with urinary catheter (13.5%).
| Variable | Value |
|---|---|
| Surgical procedures completed at time of colpocleisis, n (%) | |
| Colpocleisis with uterus in situ (LeFort) | 37 (45.1) |
| Colpocleisis/colpectomy | 45 (54.2) |
| Hysterectomy | 9 (10.8) |
| Perineorrhaphy and/or posterior repair | 69 (83.1) |
| Levatorplasty | 11 (13.3) |
| Concurrent antiincontinence procedure at time of colpocleisis, n (%) | |
| Pubovaginal sling | 1 (1.2) |
| Kelly plication | 1 (2.8) |
| Retropubic synthetic sling | 24 (28.6) |
| Transobturator synthetic sling | 10 (11.9) |
| Single incision synthetic sling | 0 (0) |
| None | 49 (58.3) |
| Anesthesia for procedure | |
| MAC/IV sedation and local, n (%) | 6 (7.4) |
| Regional, n (%) | 14 (17.3) |
| GETA, n (%) | 61 (75.3) |
| Surgery duration, min, mean (SD) | 99.4 (37.46) |
| Preoperative hemoglobin, mean (SD) | 12.7 (3.62) |
| Postoperative hemoglobin, mean (SD) | 11.1 (3.87) |
| Estimated blood loss, mL, median (IQR) | 100.0 (50–150) |
| Surgical complications, n (%) | |
| Return to operating room | 2 (2.7) |
| Transfusion | 1 (1.4) |
| D/C with catheter secondary to postoperative voiding dysfunction | 10 (13.5) |
| De novo urge incontinence requiring medication | 1 (1.4) |
| De novo stress incontinence | 1 (1.4) |
| Infection | 1 (1.4) |
| None | 58 (78.4) |
Scores on the modified BIS were evaluated ( Table 3 ). First, change in BIS score was assessed, showing significant improvement ( P < .001). Next the total scores were compared, again noting significant improvement ( P < .001). Lastly, when dichotomizing responses as normal and abnormal, we also documented positive change ( P = .001). This represents a doubling in the number of subjects with normal body image following surgery.
| Variable | Preoperative | Postoperative | P value |
|---|---|---|---|
| Modified BIS | |||
| Dichotomized score, n (%) | 26 (36.6) n = 71 | 46 (64.8) n = 71 | .001 a |
| Mean BIS score, median (IQR) | 0.25 (0–1.03) n = 78 | 0 (0–0.25) n = 74 | < .001 b |
| Total BIS score, median (IQR) | 2 (0–8.25) n = 78 | 0 (0–2.0) n = 74 | < .001 b |
| PFDI | |||
| Pelvic Organ Prolapse Distress Inventory, median (IQR) | 50 (33.3–75.0) n = 83 | 4.2 (0–25.0) n = 78 | < .001 b |
| Colorectal-Anal Distress Inventory, median (IQR) | 25 (7.7–43.8) n = 84 | 6.2 (0–21.9) n = 79 | < .001 b |
| Urinary Distress Inventory, median (IQR) | 41.7 (20.8–62.5) n = 79 | 16.7 (4.2–30.0) n = 79 | < .001 b |
| PFDI summary, median (IQR) | 121.3 (80.3–167.2) n = 78 | 33.8 (12.5–72.9) n = 78 | < .001 b |
| PFIQ | |||
| Urinary Impact Questionnaire, median (IQR) | 38.1 (10.7–57.1) n = 84 | 4.8 (0–38.1) n = 79 | < .001 b |
| Colorectal-Anal Impact Questionnaire, median (IQR) | 9.5 (0–38.1) n = 80 | 0 (0–14.3) n = 77 | .003 b |
| Pelvic Organ Prolapse Impact Questionnaire, median (IQR) | 28.6 (4.8–57.1) n = 81 | 0 (0–28.4) n = 76 | < .001 b |
| PFIQ summary, median (IQR) | 78.6 (33.7–156.0) n = 80 | 14.3 (0–76.2) n = 76 | < .001 b |
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