We analyzed data from 322 women who completed 2-year follow-up in the CARE trial, a randomized trial designed to evaluate whether a standardized modified Burch colposuspension, when added to abdominal sacrocolpopexy to treat POP, improves urinary stress continence in women without preoperative symptoms of stress urinary incontinence.10 (link), 11 (link) Each clinical site and the data coordinating center received institutional review board approval for this trial, and all participants provided written informed consent.
The methods and primary outcomes of this trial have been previously reported.10 (link),11 (link) Colpopexy and Urinary Reduction Efforts trial participants were assessed before surgery and at 2-year follow-up for pelvic organ support using the POP-Q.4 (link) In addition, pelvic symptoms and severity (Pelvic Floor Distress Inventory) along with condition-specific life impact (Pelvic Floor Impact Questionnaire) were measured via validated instruments.12 (link) Two years after surgery, women rated the overall success of their treatment (“In your opinion, has the treatment of your pelvic floor condition been _______?”) on a 4-point scale (very successful, moderately successful, somewhat successful, not at all successful) and similarly a global assessment of improvement (“Compared with how you were doing before your recent pelvic floor operation, would you say that now you are _______?”) on a 5-point scale (much better, a little better, about the same, a little worse, much worse).
We created 18 different definitions of surgical success by using POP-Q assessments, responses to Pelvic Floor Distress Inventory questions regarding vaginal bulging, data on re-treatment (surgery or pessary), and participant’s subjective ratings of overall treatment success and global improvement as listed inTable 1 . The proposed definitions of treatment success consist of those recommended in the NIH Standardization Workshop and several used by clinical trials or prospective cohorts evaluating treatment success after prolapse surgery including one from an ongoing clinical trial being conducted by the Pelvic Floor Disorders Network (the OPTIMAL Trial).1 ,2 (link),7 (link)–9 (link),13 (link)
Definitions assessing anatomic outcomes used POP-Q measurements at 2-year follow-up to define treatment success or failure. To evaluate definitions that used the Baden-Walker system,14 (link) POP-Q measurements were used to approximate Baden-Walker grades 0–3. For instance, treatment success defined as Baden-Walker grade 0, 1, or 2 translates into “no descent of the vaginal walls beyond the hymen” or POP-Q measurements Ba, Bp, and C less than or equal to 0. Treatment success defined as Baden-Walker grade 0 or 1 corresponds to “no vaginal descent beyond the half-way point of the vagina.” For the apex, this translates into a POP-Q measurement of point C that does not descend more than one-half the total vaginal length (Point C less than or equal to 1/2 total vaginal length). For the anterior and posterior vaginal segments, there is no obvious direct translation to POP-Q measurements, so we assigned the criteria for success for the anterior/posterior segments as Bp and Ba less than −1 for this definition of treatment success to best approximate the Baden-Walker system.
Subjective cure was defined as the absence of vaginal bulge symptoms as indicated by a negative response at 2-year follow-up to the questions “Do you usually have a sensation of bulging or protrusion from the vaginal area?” and “Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?” from the Pelvic Floor Distress Inventory.12 (link) We chose this definition of subjective cure as the patient’s ability to see or feel a vaginal bulge as the symptom most consistently related to the presence or absence of POP.15 (link)
Re-treatment for POP was defined as any reoperation or use of pessary for recurrent POP over the 2-year follow-up period. Definitions of treatment success compositing anatomic outcomes, subjective cure, and/or re-treatment were also considered.
For each of 18 dichotomous definitions of treatment success, the proportion of women who had a successful outcome was reported for all analyzed CARE women. This cure rate was further compared between the women who received a Burch colposuspension and those who did not for each proposed definition by using χ2 or Fisher exact test. Additionally, the proportion of women with missing data that precluded a determination of success or failure for each definition was also determined. To evaluate the clinical relevance of each definition from a patient’s perspective, we examined the relationship of subjective assessment of treatment success and the global impression of improvement to different definitions of surgical treatment success by comparing the assessments between those who met the criteria of treatment success to those who did not. Likewise, the comparisons between surgical success and failure groups were performed on the scores of the prolapse scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire (Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire). A clinically relevant definition of surgical success should demonstrate significantly better global impression of improvement, lower symptom bother (lower Pelvic Floor Distress Inventory scores), and higher health-related quality of life (lower Pelvic Floor Impact Questionnaire scores) in treatment successes than in failures. Mean and standard deviation were reported for the ordinal outcomes of subjective assessments and Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores, and the Wilcoxon rank sum test was used to identify any significant difference in outcomes between success and failure. All reported P values were based on the two-sided statistical tests and intended to be interpreted from a hypothesis-generating framework. The analyses were performed in SAS 9.1.3 for Windows (SAS Inc., Cary, NC).
The methods and primary outcomes of this trial have been previously reported.10 (link),11 (link) Colpopexy and Urinary Reduction Efforts trial participants were assessed before surgery and at 2-year follow-up for pelvic organ support using the POP-Q.4 (link) In addition, pelvic symptoms and severity (Pelvic Floor Distress Inventory) along with condition-specific life impact (Pelvic Floor Impact Questionnaire) were measured via validated instruments.12 (link) Two years after surgery, women rated the overall success of their treatment (“In your opinion, has the treatment of your pelvic floor condition been _______?”) on a 4-point scale (very successful, moderately successful, somewhat successful, not at all successful) and similarly a global assessment of improvement (“Compared with how you were doing before your recent pelvic floor operation, would you say that now you are _______?”) on a 5-point scale (much better, a little better, about the same, a little worse, much worse).
We created 18 different definitions of surgical success by using POP-Q assessments, responses to Pelvic Floor Distress Inventory questions regarding vaginal bulging, data on re-treatment (surgery or pessary), and participant’s subjective ratings of overall treatment success and global improvement as listed in
Definitions assessing anatomic outcomes used POP-Q measurements at 2-year follow-up to define treatment success or failure. To evaluate definitions that used the Baden-Walker system,14 (link) POP-Q measurements were used to approximate Baden-Walker grades 0–3. For instance, treatment success defined as Baden-Walker grade 0, 1, or 2 translates into “no descent of the vaginal walls beyond the hymen” or POP-Q measurements Ba, Bp, and C less than or equal to 0. Treatment success defined as Baden-Walker grade 0 or 1 corresponds to “no vaginal descent beyond the half-way point of the vagina.” For the apex, this translates into a POP-Q measurement of point C that does not descend more than one-half the total vaginal length (Point C less than or equal to 1/2 total vaginal length). For the anterior and posterior vaginal segments, there is no obvious direct translation to POP-Q measurements, so we assigned the criteria for success for the anterior/posterior segments as Bp and Ba less than −1 for this definition of treatment success to best approximate the Baden-Walker system.
Subjective cure was defined as the absence of vaginal bulge symptoms as indicated by a negative response at 2-year follow-up to the questions “Do you usually have a sensation of bulging or protrusion from the vaginal area?” and “Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?” from the Pelvic Floor Distress Inventory.12 (link) We chose this definition of subjective cure as the patient’s ability to see or feel a vaginal bulge as the symptom most consistently related to the presence or absence of POP.15 (link)
Re-treatment for POP was defined as any reoperation or use of pessary for recurrent POP over the 2-year follow-up period. Definitions of treatment success compositing anatomic outcomes, subjective cure, and/or re-treatment were also considered.
For each of 18 dichotomous definitions of treatment success, the proportion of women who had a successful outcome was reported for all analyzed CARE women. This cure rate was further compared between the women who received a Burch colposuspension and those who did not for each proposed definition by using χ2 or Fisher exact test. Additionally, the proportion of women with missing data that precluded a determination of success or failure for each definition was also determined. To evaluate the clinical relevance of each definition from a patient’s perspective, we examined the relationship of subjective assessment of treatment success and the global impression of improvement to different definitions of surgical treatment success by comparing the assessments between those who met the criteria of treatment success to those who did not. Likewise, the comparisons between surgical success and failure groups were performed on the scores of the prolapse scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire (Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire). A clinically relevant definition of surgical success should demonstrate significantly better global impression of improvement, lower symptom bother (lower Pelvic Floor Distress Inventory scores), and higher health-related quality of life (lower Pelvic Floor Impact Questionnaire scores) in treatment successes than in failures. Mean and standard deviation were reported for the ordinal outcomes of subjective assessments and Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores, and the Wilcoxon rank sum test was used to identify any significant difference in outcomes between success and failure. All reported P values were based on the two-sided statistical tests and intended to be interpreted from a hypothesis-generating framework. The analyses were performed in SAS 9.1.3 for Windows (SAS Inc., Cary, NC).
