NEW ORLEANS — Colpocleisis successfully resolves pelvic organ prolapse and patient satisfaction rates are extremely high 1 year after surgery, according to a cohort study of 153 patients.
Colpocleisis is a “time-honored procedure,” having been performed for a century, but fell out of favor for many years, partly because of concerns about its effects on women's body image and sexual function, said Dr. Mary P. FitzGerald of the Loyola University Medical Center in Maywood, Ill. The procedure has rarely been formally studied with validated scales or to record outcomes, she added.
Dr. FitzGerald presented an analysis of the study, which was part of the National Institutes of Health-sponsored Pelvic Floor Disorders Network, at the annual meeting of the American College of Obstetricians and Gynecologists.
The researchers had two aims—to determine how difficult it was to recruit and retain older women in such a trial, and to assess morbidity, outcomes, and patient satisfaction with colpocleisis, she said.
Dr. FitzGerald and her colleagues looked at 153 women who already were undergoing colpocleisis for pelvic organ prolapse at six clinical centers participating in the NIH collaborative. Prolapse severity, symptoms, and quality of life were measured at baseline. The Pelvic Floor Distress Inventory (which includes the Pelvic Organ Prolapse Distress Inventory) and Pelvic Floor Impact Questionnaires were used, along with the Short Form 36. The researchers also recorded results of incontinence complaints before surgery.
All of the measures were recorded again at 3 months and 1 year post surgery. Women were also asked how they felt, how they perceived their body, and how they rated their sexual function relative to before the colpocleisis.
Ninety-two percent of the participants were white, with an age range of 65-94 years. Sixty percent had had a hysterectomy before the colpocleisis; 62% had a stage 3 prolapse, with the remainder having stage 4. Thirteen women (8%) had a hysterectomy at the time of the colpocleisis.
Serious adverse events were uncommon during the initial hospital stay (mean of 1.6 days), but included one case of pneumonia, one of pulmonary edema, two transfusions, two cardiac arrhythmias, and one case of hyponatremia.
There was one death, due to heart failure at 5 months post surgery; 133 women completed follow-up out to 1 year. Success—defined as all vaginal points at 1 cm or less beyond the hymen—was 97% at 3 months and 93% at 1 year. At 3 months, 97% of women had stage 1 or 2 prolapse, and 82% had stage 0 or 1; that result persisted for 1 year, said Dr. FitzGerald.
Forty-five percent of patients (69) had a simultaneous procedure to restore continence. This was not randomized or controlled, but a matter of patient choice, she said. About half the patients reported bothersome stress incontinence at baseline. That was reduced to 19% at 3 months and 14% at 1 year.
At 1 year, 85% of those who had the procedure were continent, compared with 80% of those who did not.
New-onset bothersome stress incontinence was rare, affecting only about 4% of those who had a continence procedure, but a third of those who did not have a simultaneous surgery.
All prolapse symptoms improved at 3 months, and improvement was maintained at 1 year.
The mean Pelvic Organ Prolapse Distress Inventory score dropped from 113 to 26 at 1 year after surgery. At that time, 95% (126 of those who completed follow-up) said they were very satisfied or satisfied with their decision to have colpocleisis.
Ninety-eight percent said their body looked better, compared with before the surgery; 98% said it felt better, and 97% said their sexual function was the same or improved.
Dr. FitzGerald concluded that colpocleisis “is an excellent procedure for prolapse correction.” And, she added, “We found that body image and sexual function were not adversely affected.”
A limitation of the study is that it did not compare colpocleisis to other prolapse procedures, Dr. FitzGerald said, adding that that would be important information to have.