INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

<p>Abstract</p> <p>Background</p> <p>Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness.</p> <p>The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness.</p> <p>Methods/design</p> <p>This is a mixed methods pragmatic multicentre feasibility pilot study with four components:-</p> <p>(a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial.</p> <p>(b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience.</p> <p>(c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial.</p> <p>(d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions.</p> <p>Discussion</p> <p>The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim.</p> <p>Trial registration number</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN71327395">ISRCTN71327395</a> assigned 7^thJune 2010.</p

Prevalence and risk factors for mesh erosion after laparoscopic-assisted sacrocolpopexy

Introduction and hypothesis: The purpose of this study is to identify risk factors for mesh erosion in women undergoing minimally invasive sacrocolpopexy (MISC). We hypothesize that erosion is higher in subjects undergoing concomitant hysterectomy. Methods: This is a retrospective cohort study of women who underwent MISC between November 2004 and January 2009. Demographics, operative techniques, and outcomes were abstracted from medical records. Multivariable regression identified odds of erosion. Results: Of 188 MISC procedures 19(10%) had erosions. Erosion was higher in those with total vaginal hysterectomy (TVH) compared to both post-hysterectomy (23% vs. 5%, p = 0.003) and supracervical hysterectomy (SCH) (23% vs. 5%, p = 0.109) groups. In multivariable regression, the odds of erosion for TVH was 5.67 (95% CI: 1.88-17.10) compared to post-hysterectomy. Smoking, the use of collagen-coated mesh, transvaginal dissection, and mesh attachment transvaginally were no longer significant in the multivariable regression model. Conclusion: Based on this study, surgeons should consider supracervical hysterectomy over total vaginal hysterectomy as the procedure of choice in association with MISC unless removal of the cervix is otherwise indicated. © 2010 The Author(s)

Outcome measures to assess anatomy and function of the posterior vaginal compartment.

Introduction and hypothesisOptimal measures for assessing anatomy and defecatory symptoms related to posterior compartment prolapse are unknown. Our objectives were: (1) to test the inter- and intrarater reliability of commonly used or reported anatomic measures of posterior compartment prolapse performed in the clinic setting and under anesthesia; and (2) to examine the correlation between posterior compartment anatomy and defecatory symptoms prior to surgical intervention.MethodsA prospective cohort of women with pelvic floor disorders was assessed using a variety of validated questionnaires and standardized examination measures at baseline, at a preoperative visit, and intraoperatively. Inter- and intrarater reliability for anatomic measures were assessed by two separate examiners at the initial visit and repeated by one of the original examiners at a preoperative visit. Reliability was measured using kappa or intraclass correlations according to data type. Symptom and anatomic measure correlations were analyzed using Spearman rank tests.ResultsMean age of the 120 women recruited was 57 ± 15&nbsp;years, 49 (41&nbsp;%) had a point Bp ≥ 0; 59&nbsp;% reported at least moderate bother from at least one obstructed defecation symptom on the Pelvic Floor Distress Inventory (PFDI). At baseline, most anatomic measures showed at least moderate to good inter/intrarater reliability (&gt; 0.5). There were no moderate or better correlations between any symptom and anatomic measure (all r &lt;  0.27).ConclusionsMost anatomic measures of posterior compartment prolapse are reliable and reproducible; however, they do not correlate well with defecatory symptoms

Outcome measures to assess anatomy and function of the posterior vaginal compartment.

Introduction and hypothesisOptimal measures for assessing anatomy and defecatory symptoms related to posterior compartment prolapse are unknown. Our objectives were: (1) to test the inter- and intrarater reliability of commonly used or reported anatomic measures of posterior compartment prolapse performed in the clinic setting and under anesthesia; and (2) to examine the correlation between posterior compartment anatomy and defecatory symptoms prior to surgical intervention.MethodsA prospective cohort of women with pelvic floor disorders was assessed using a variety of validated questionnaires and standardized examination measures at baseline, at a preoperative visit, and intraoperatively. Inter- and intrarater reliability for anatomic measures were assessed by two separate examiners at the initial visit and repeated by one of the original examiners at a preoperative visit. Reliability was measured using kappa or intraclass correlations according to data type. Symptom and anatomic measure correlations were analyzed using Spearman rank tests.ResultsMean age of the 120 women recruited was 57 ± 15&nbsp;years, 49 (41&nbsp;%) had a point Bp ≥ 0; 59&nbsp;% reported at least moderate bother from at least one obstructed defecation symptom on the Pelvic Floor Distress Inventory (PFDI). At baseline, most anatomic measures showed at least moderate to good inter/intrarater reliability (&gt; 0.5). There were no moderate or better correlations between any symptom and anatomic measure (all r &lt;  0.27).ConclusionsMost anatomic measures of posterior compartment prolapse are reliable and reproducible; however, they do not correlate well with defecatory symptoms