A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery

Abstract

Background Evidence on efficacy and safety of pelvic organ prolapse interventions is variable, and methodological flaws preclude meaningful synthesis of primary research data. Objective To evaluate variations in reported outcomes and outcome measures in randomized controlled trials (RCTs) on apical prolapse surgical interventions. Search strategy We searched Cochrane, EMBASE, MEDLINE, and Scopus for English‐language articles published from inception to September 30, 2017, using the terms “management”, “repair”, “operation”, and “pelvic organ prolapse”. Selection criteria RCTs on apical prolapse surgical treatment. Data collection and analysis Outcomes and outcome measures were identified and categorized into domains. Studies were evaluated for quality of outcomes. Descriptive statistics were used to calculate frequencies. Main results Forty‐three RCTs were included. Seventy‐six outcomes and 66 outcome measures were identified. Bladder and ureteric injury were the most commonly reported intraoperative complications (19/31 studies; 61%). Quality of life was assessed by 19 different instruments and questionnaires. Fourteen (45%) of 31 studies used recurrence of prolapse as a postoperative anatomical outcome. Conclusions Substantial variation in reported outcomes and outcome measures was confirmed, precluding comparisons across trials and synthesis of the results. Development of a core outcome set will enable high‐quality meta‐analyses to be performed in the future. PROSPERO registration: CRD42017062456.

A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set

“…This systematic review aimed to evaluate the selection and reporting of outcomes and the use of outcome measures in RCTs evaluating surgical treatments for posterior vaginal prolapse. We demonstrated a wide variation in outcomes, as expected, and to a similar degree as our systematic reviews on other prolapse interventions . Intraoperative and postoperative outcomes were the domains extensively documented.…”

“…The current findings are consistent with our recent systematic reviews of other pelvic floor disorders (perineal, anterior, mesh, apical). Inherent causes of these variations are expected to feature in all such trials and may be secondary to the lack of standardization of surgical techniques, surgical routes, different materials, and/or different specialties (gynecology, urogynecology, colorectal surgery) performing the surgical procedures for posterior compartment prolapse, in addition to inherent causes that may apply to all trials, such as research priorities, underreporting of adverse events, overreporting of success outcomes, and surgeon's preference or expertise in specific procedures.…”

Urotherapist activities in caring for patients with pelvic floor disorders: a prospective single-center observational study

“…It was previously reported that the counselling of patients with pelvic organ prolapse and the fitting of pessaries by an advanced nurse practitioner is an effective conservative treatment [23,24]. Pessary treatment is gaining more importance as part of a urotherapy, especially since pelvic organ prolapse surgery is under debate due to recurrences and complication rates [25]. Pessaries are a safe and effective treatment option for women with pelvic organ prolapse; managing these patients needs person-centered care, which is a core activity of urotherapists [26].…”

Hysteropexy in the treatment of uterine prolapse

“…At short-term follow-up, the procedure was successful in 50 out of 51 women, with no objective evidence of uterine prolapse on examination [45]. High patient satisfaction with low rates of apical prolapse recurrence was found at mean follow-up of 2 years [46]. Furthermore, the risk of repeat apical surgery at one year after laparoscopic sacrohysteropexy was similar as compared to vaginal hysterectomy, suggesting this procedure is a safe surgical alternative to vaginal hysterectomy [47].…”

“…outcomes and 66 outcome measures were identified [46]. As a result of heterogenous outcomes, meaningful meta-analysis of POP outcome data is impossible [47].…”