The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction

Bump, Richard C.; Mattiasson, Anders; Bø, Kari; Brubaker, Linda; DeLancey, John O.L.; Klarskov, Peter; Shull, Bobby L.; Smith, Anthony

doi:10.1016/s0002-9378(96)70243-0

Cited by 3,794 publications

(971 citation statements)

References 1 publication

Supporting

Mentioning

917

Contrasting

Unclassified

Order By: Relevance

“…Objective prolapse staging was carried out using the POP-Q system. 27 This measures the maximum descent of each of the three prolapse compartments (anterior, posterior and upper) relative to the hymen (at 0 cm): measurements inside the vagina are negative, whereas those outside are positive. A measure of prolapse (classified from stage 0 to 4) was determined for anterior, posterior and uterine/vault, with the leading edge of the most descended compartment used to define overall stage.…”

Section: Objective Prolapse Measurementmentioning

confidence: 99%

“…Usually, using the classic Bump et al 27 criteria for the POP-Q system, any measurement from -1 cm (inside the hymen) to 1 cm outside counts as stage 2. However, we further subdivided stage 2 into prolapse at the hymen or within (-1 cm to 0 cm; stage 2a or less) compared with prolapse at > 0 cm (stage 2b).…”

Section: Objective Prolapse Measurementmentioning

confidence: 99%

“…Although gynaecologists were expected to use the POP-Q, 27 not all did so. However, attempts were made to locate important missing data from the centres, using alternative sources such as medical notes, correspondence and asking the centre staff.…”

Section: Preoperative Objective Measurementsmentioning

confidence: 99%

“…Our primary measure of prolapse symptoms was the subjective woman-reported prolapse symptom scale (Pelvic Organ Prolapse Symptom scale), developed and validated in a variety of populations for both research and in clinical practice. 27 This tool is relevant to women and, arguably, focused on the symptoms that led them to seek treatment.…”

Section: Choice Of Validated Outcome Measuresmentioning

confidence: 99%

“…27 Although the majority of women were classed as stage 2, based on the leading edge of the prolapse, some researchers have called into question whether or not this is an appropriate cut-off point for the diagnosis of prolapse. The mismatch between symptoms and objective findings is well recognised.…”

Section: Choice Of Validated Outcome Measuresmentioning

confidence: 99%

See 4 more Smart Citations

Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study – results from the PROSPECT Study

Glazener

Breeman

Elders

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

BackgroundThe use of mesh in prolapse surgery is controversial, leading to a number of enquiries into its safety and efficacy.ObjectiveTo compare synthetic non-absorbable mesh inlay, biological graft and mesh kit with a standard repair in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness.DesignTwo randomised controlled trials within a comprehensive cohort (CC) study. Allocation was by a remote web-based randomisation system in a 1 :1 : 1 ratio (Primary trial) or 1 : 1 : 2 ratio (Secondary trial), and was minimised on age, type of prolapse repair planned, need for a concomitant continence procedure, need for a concomitant upper vaginal prolapse procedure and surgeon. Participants and outcome assessors were blinded to randomisation; participants were unblinded if they requested the information. Surgeons were not blinded to allocated procedure.SettingThirty-five UK hospitals.ParticipantsPrimary study: 2474 women in the analysis (including 1348 randomised) having primary anterior or posterior prolapse surgery.Secondary study: 398 in the analysis (including 154 randomised) having repeat anterior or posterior prolapse surgery.CC3: 215 women having either uterine or vault prolapse repair.InterventionsAnterior or posterior repair alone, or with mesh inlay, biological graft or mesh kit.Main outcome measuresProlapse symptoms [Pelvic Organ Prolapse Symptom Score (POP-SS)]; prolapse-specific QoL; cost-effectiveness [incremental cost per quality-adjusted life-year (QALY)].ResultsPrimary trials: adjusting for baseline and minimisation covariates, mean POP-SS was similar for each comparison {standard 5.4 [standard deviation (SD) 5.5] vs. mesh 5.5 (SD 5.1), mean difference (MD) 0.00, 95% confidence interval (CI) –0.70 to 0.71; standard 5.5 (SD 5.6) vs. graft 5.6 (SD 5.6), MD –0.15, 95% CI –0.93 to 0.63}. Serious non-mesh adverse effects rates were similar between the groups in year 1 [standard 7.2% vs. mesh 7.8%, risk ratio (RR) 1.08, 95% CI 0.68 to 1.72; standard 6.3% vs. graft 9.8%, RR 1.57, 95% CI 0.95 to 2.59]. There were no statistically significant differences between groups in any other outcome measure. The cumulative mesh complication rates over 2 years were 2 of 430 (0.5%) for standard repair (trial 1), 46 of 435 (10.6%) for mesh inlay and 2 of 368 (0.5%) for biological graft. The CC findings were comparable. Incremental costs were £363 (95% CI –£32 to £758) and £565 (95% CI £180 to £950) for mesh and graft vs. standard, respectively. Incremental QALYs were 0.071 (95% CI –0.004 to 0.145) and 0.039 (95% CI –0.041 to 0.120) for mesh and graft vs. standard, respectively. A Markov decision model extrapolating trial results over 5 years showed standard repair had the highest probability of cost-effectiveness, but results were surrounded by considerable uncertainty.Secondary trials: there were no statistically significant differences between the randomised groups in any outcome measure, but the sample size was too small to be conclusive. The cumulative mesh complication rates over 2 years were 7 of 52 (13.5%) for mesh inlay and 4 of 46 (8.7%) for mesh kit, with no mesh exposures for standard repair.ConclusionsIn women who were having primary repairs, there was evidence of no benefit from the use of mesh inlay or biological graft compared with standard repair in terms of efficacy, QoL or adverse effects (other than mesh complications) in the short term. The Secondary trials were too small to provide conclusive results.LimitationsWomen in the Primary trials included some with a previous repair in another compartment. Follow-up is vital to identify any long-term potential benefits and serious adverse effects.Future workLong-term follow-up to at least 6 years after surgery is ongoing to identify recurrence rates, need for further prolapse surgery, adverse effects and cost-effectiveness.TriaI registrationCurrent Controlled Trials ISRCTN60695184.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 95. See the NIHR Journals Library website for further project information.

show abstract

Section: Objective Prolapse Measurementmentioning

confidence: 99%

Section: Objective Prolapse Measurementmentioning

confidence: 99%

Section: Preoperative Objective Measurementsmentioning

confidence: 99%

Section: Choice Of Validated Outcome Measuresmentioning

confidence: 99%

Section: Choice Of Validated Outcome Measuresmentioning

confidence: 99%

See 3 more Smart Citations

Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study – results from the PROSPECT Study

Glazener

Breeman

Elders

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

show abstract

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

Nygaard

Brubaker

Zyczynski

et al. 2013

JAMA

468

252

View full text Add to dashboard Cite

Probability of mesh erosion at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). Conclusions and Relevance During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with longterm risks of mesh or suture erosion. Trial Registration clinicaltrials.gov Identifier: NCT00099372

show abstract

Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse

Barber

Brubaker

Burgio

et al. 2014

JAMA

368

236

View full text Add to dashboard Cite

IMPORTANCE Over 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE To compare outcomes between 1) SSLF and ULS and 2) perioperative BPMT and usual perioperative care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING AND PARTICIPANTS Multi-center, 2×2 factorial randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 U.S. medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS Surgical intervention: Transvaginal surgery including mid-urethral sling with randomization to SSLF (n = 186) or ULS (n=188); Behavioral intervention: Randomization to perioperative BPMT (n = 186) or usual care (n=188). MAIN OUTCOME MEASURES The primary outcome for the surgical intervention (surgical success) was defined as: 1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success); 2) no bothersome vaginal bulge symptoms and 3) no retreatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0–300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0–300, higher scores worse) and anatomic success. RESULTS At 2 years, surgical group was not significantly associated with surgical success rates [ULS 59.2% (93/154) vs. SSLF 60.5% (92/152), OR 0.9 (95% CI 0.6, 1.5)] or serious adverse event rates [ULS 16.5% (31/188) vs. SSLF 16.7% (31/186), OR 0.9 (95% CI 0.5, 1.6)]. BPMT was not associated with greater improvements in urinary scores at 6 months [treatment difference −6.7 (95% CI −19.7, 6.2)], prolapse scores at 24 months [treatment difference −8.0 (95% CI −22.1, 6.1)] or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, and or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.

show abstract

The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction

Cited by 3,794 publications

References 1 publication

Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study – results from the PROSPECT Study

Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study – results from the PROSPECT Study

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse

Contact Info

Product

Resources

About