PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse.

INTRODUCTION AND HYPOTHESIS: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. METHODS: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. RESULTS: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. CONCLUSIONS: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

An assessment of techniques and practices used to elevate intra-abdominal pressure when assessing pelvic floor dysfunction.

AIMS: To determine terminology and methods for raising intra-abdominal pressure (IAP) currently used by clinicians to assess pelvic floor dysfunction (PFD) and to measure the effect of these maneuvers on IAP. METHODS: Three-hundred questionnaires were distributed at two scientific meetings in the United Kingdom to determine methods clinicians used to raise IAP and their perceptions of these methods. Twenty healthy volunteers were also recruited to measure the effect of two methods of raising IAP: Valsalva maneuver (VM) and bear down maneuver (BDM). IAP pressure was measured with rectal catheters connected to pressure sensors. The IAP was measured during each maneuver in both standing and supine positions. RESULTS: Maneuvers used in practice were cough (79%), BDM (60%), and VM (38%). 44% of clinicians felt patients found it difficult to raise their IAP. There was uncertainty among clinicians as to which method was the most effective in raising IAP and whether the different methods produced the same rise in IAP. On testing IAP in 20 healthy volunteers, median (interquartile range) IAP generated during BDM; 101 (59.1) cmH2 O was significantly higher than that generated during VM; 80.3 (43.6) cmH2 O (p < .0001). CONCLUSION: Clinicians varied widely in the maneuvers they used to raise patients' IAP to test for PFD and there was uncertainty about the maneuvers' effect on IAP. In healthy volunteers, BDM produced significantly higher IAP than VM. We recommend standardization of terminology and techniques used to raise IAP when assessing PFD, to ensure consistency of diagnosis and assessment of treatment outcomes.

Teaching and learning in urogynecology.

This paper was delivered as the Ulf Ulmsten Memorial Lecture in Brisbane, QLD, Australia, in 2012. It emphasises how urogynaecology as a young specialty needs to learn some lessons from its forebears as to how new knowledge should be analysed and incorporated into practice. The paper highlights the value of mentorship and teamwork and the need to be aware of increasing patient expectations.

The impact of pregnancy and childbirth on pelvic sensation: a prospective cohort study.

Pelvic organ prolapse, urinary, bowel and sexual dysfunction, collectively called pelvic floor dysfunction (PFD) affects 1 in 3 women and has a significant public health impact. The causes of PFD are not fully understood but involve injury to connective tissue and motor nerve during childbirth. Women with PFD also have sensory nerve impairment, and it is likely this occurs during childbirth, but this has never been investigated. In the current study 150 women underwent quantitative sensory testing for vibration sensation at the vagina and clitoris, and stretch sensation at the vagina and introitus, in the third trimester, 3 and 6 months postnatal. Antenatally vibration sensation was reduced but stretch sensation was normal. Postnatally vibration sensation deteriorated whilst stretch sensation initially deteriorated but recovered by 6 months postnatal to antenatal levels (all p < 0.001). Mode of birth had a significant impact on sensation, with caesarean section appearing neuroprotective, normal vaginal birth resulted in a transient deterioration in sensation that recovered by 6 months, whilst assisted vaginal delivery was prolonged suggesting persistent neurological impairment (all p < 0.015). Further research is required to study the clinical effect of these changes on pelvic floor dysfunction in the medium and long-term.

Can we, and do we need to, define bladder neck hypermobility and intrinsic sphincteric deficiency? ICI-RS 2011.

AIMS: Bladder neck hypermobility (BNH, also called urethral hypermobility), and intrinsic sphincteric deficiency (ISD) are terms frequently used in the clinical evaluation and management of stress urinary incontinence, and as subject qualifiers in clinical research. The terms also infer pathophysiologic concepts, as BNH and ISD appear to represent two different aspects of failure of the continence mechanism. Unfortunately, neither term is well-defined, and the various clinical and urodynamic characterizations of these terms do not correlate well with one another. METHODS: The value of these concepts and these specific terms was debated at the ICI-RS meeting, Bristol, UK, June 2011. Two clinicians were asked to take opposing viewpoints, with three weeks lead-time prior to the meeting. Each discussant presented one viewpoint, "for" or "against," followed by a brief discussion to review the presentations. RESULTS: The consensus was that, while we currently cannot adequately define these terms, there is a need to develop terminology employing these concepts. CONCLUSIONS: Terminology should permit improved definition of the sphincteric mechanism, allow individual patient characterization and serve as useful waypoints in treatment decisions.

Managing unsatisfactory outcome after mid-urethral tape insertion.

This article reviews the literature on the assessment and management of women whose previous mid-urethral tape surgery to manage stress urinary incontinence symptoms has failed to produce a satisfactory outcome. In many areas the literature is deficient and the article includes consensus statements drawn from the International Continence Society Research Society meeting in Bristol in June 2010. The need for a structured approach to assessment and management is highlighted, so that further research into areas of uncertainty can be prioritized. The article concludes with a number of research recommendations.

Prospective study of anterior transobturator mesh kit (Prolift™) for the management of recurrent anterior vaginal wall prolapse.

INTRODUCTION AND HYPOTHESIS: Assessment of the 2-year outcome of anterior Prolift™ for women with recurrent anterior vaginal wall prolapse. This is a prospective study which was conducted in a tertiary unit in the North West of England and comprised 36 consecutive women with recurrent anterior vaginal wall prolapse. METHODS: Women were assessed preoperatively and postoperatively at 6 months and 2 years. Women completed the Prolapse Quality of Life Questionnaire (P-QOL), Prolapse and Incontinence Sexual Function Questionnaire-Short Form (PISQ-12), and postoperatively, the Global Impression of Improvement Questionnaire. Women were examined using the Pelvic Organ Prolapse Quantification System (POP-Q). Anatomical success was defined as stage ≤1 prolapse in the anterior compartment. Main outcome measures Postoperative POP-Q stage, quality of life domains and mesh exposure rate. RESULTS: Preoperatively all but two women had stage 2 or greater anterior vaginal wall prolapse. At a mean follow-up of 24.6 months, 19 women (53%) had stage ≤1 anterior wall prolapse. Fifteen women had stage 2 anterior wall prolapse and two women had stage 3 prolapse. Twenty-nine women felt improvement in their prolapse symptoms. 16 women were sexually active preoperatively, of whom seven reported worsening dyspareunia. There was poor correlation between anatomical and functional outcomes. Seven women had mesh exposure. Five needed revision in theatre. CONCLUSIONS: Anterior Prolift™ for recurrent anterior vaginal wall prolapse has 53% anatomical success rate in the medium term, with mesh exposure rate of 19%. Majority of patients felt overall improvement in their symptoms, but this did not correlate with the anatomical outcome.

One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device.

OBJECTIVE: The purpose of this study was to evaluate outcomes after standardized transvaginal prolapse repair with nonanchored mesh and a vaginal support device. STUDY DESIGN: Postoperative vaginal support was assessed by pelvic organ prolapse quantitative examination after repair of symptomatic stage II/III prolapse. Validated questionnaires assessed pelvic symptoms and sexual function. Visual analog scales quantified experience with the vaginal support device. RESULTS: One hundred thirty-six women received the planned surgery; 95.6% of the women returned for the 1-year assessment: 76.9% of the cases were stage 0/I; however, in 86.9% of the cases, the leading vaginal edge was above the hymen. Pelvic symptoms, quality of life, and sexual function improved significantly from baseline (P < .05). Median visual analog scale scores for vaginal support device awareness and discomfort were 2.6 and 1.2, respectively (0 = none; 10 = worst possible). CONCLUSION: Vaginal support, pelvic symptoms, and sexual function improved at 1 year, compared with baseline, after trocar-free prolapse repair with nonanchored mesh and a vaginal support device.

Is mid-urethral placement of synthetic minimal access tapes important in stress urinary incontinence surgery?

The introduction of the tension free vaginal tape over a decade ago heralded the adoption of sub-urethral sling placement under the mid-urethra rather than the proximal urethra. This paper reviews the literature which led to the change in practice and also looks at which factors concerning tape position influence surgical outcome with particular reference to the position along the urethra. There is conflicting evidence on the importance of the mid-urethral position and there is also evidence that other factors such as the configuration of the tape under the urethra at rest and under strain and the proximity of the tape to the urethral mucosa may be as important in influencing outcome. Further research is required.

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

BACKGROUND: One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. METHODS/DESIGN: VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation. DISCUSSION: Demonstrating the efficacy of vault and uterine prolapse surgeries is relevant not only to patients and clinicians but also to health care providers, both in the UK and globally. TRIAL REGISTRATION: Current controlled trials ISRCTN86784244 (assigned 19 October 2012), and the first subject was randomly assigned on 1 May 2013.

Ambulatory surgery in urogynaecology.

Ambulatory surgery offers advantages to both patients and providers. It is imperative to ensure appropriate case selection, pre-operative counseling, a suitable environment, trained staff, adequate analgesia and post-operative care both in the hospital and the community. Many well-established urogynaecological procedures such as cystoscopy and vaginal repair may be performed in an ambulatory setting. Newer procedures such as injection of botulinum toxin or peri-urethral bulking agents and tension-free tapes for stress incontinence may also be performed in this way. To date, the literature is deficient in robust studies comparing outcomes and patient satisfaction between conventional and ambulatory surgical procedures, and randomized controlled trials are required.

The long-term outcome of laparoscopic colposuspension: a 10-year cohort study.

INTRODUCTION AND HYPOTHESIS: The aim of this study is to provide long-term outcome data, at least 10 years, following laparoscopic colposuspension. METHODS: The study includes a control group who underwent open colposuspension. A consecutive series of 139 women who had undergone laparoscopic colposuspension were reviewed and compared to 52 women who had an open colposuspension in the same unit. Subjects were contacted by telephone, at least 10 years post-operatively, at which time a structured interview was performed which included the short-form Bristol Female Lower Urinary Tract Symptom questionnaire. RESULTS: There was deterioration in subjective cure rates from 71% and 67% at 6 months to 52% and 36% at 10 years for the laparoscopic and open procedures, respectively. CONCLUSION: This study provides evidence that laparoscopic colposuspension is probably as durable as open colposuspension. However, cure rates for both procedures appear to deteriorate over time, emphasising the importance of long-term follow-up.

Laparoscopic versus open colposuspension: which one should we choose?

PURPOSE OF REVIEW: The aim of this review is to present a summary of recently published research comparing laparoscopic and open colposuspension. It also examines the place of colposuspension in light of the continuing development other minimally invasive procedures for stress urinary incontinence. RECENT FINDINGS: The results of two large multicentre randomised controlled trials were published in 2006 comparing open and laparoscopic colposuspension. Carey et al. randomised 200 women to open or laparoscopic colposuspension. The primary outcome objective was cure 6 months postoperatively. Cure was defined as the absence of urodynamic stress incontinence. Patients' subjective outcomes were assessed 3-5 years postoperatively. Kitchener et al. reported a randomised controlled trial in which 291 women were recruited. The primary end point of the study was objective cure at 2 years. This was defined as <1 g of urinary leakage during a 1 h standardised pad test. Both trials demonstrated no significant differences between laparoscopic and open colposuspension in objective and subjective measures of cure of stress urinary incontinence at 24 months. SUMMARY: There is now level 1 evidence that the clinical outcomes with laparoscopic Burch colposuspension are similar to open Burch colposuspension.

Which questionnaire? A psychometric evaluation of three patient-based outcome measures used to assess surgery for stress urinary incontinence.

AIMS: The aim of the study was to further validate three patient-based outcome measures (PBOM) used to assess the outcome of surgery for stress urinary incontinence and to compare their psychometric properties with a view to determining the most appropriate measure for clinical use. METHODS: The work was embedded within a randomized controlled trial of laparoscopic and open colposuspension. The trial recruited 291 women from six centers. The three instruments compared were Bristol Female Lower Urinary Tract Symptom Questionnaire (BFLUTS), Kings Health Questionnaire (KHQ), and the Symptom Severity Index and Symptom Impact Index (SSI/SII). The International Consultation on Incontinence (ICI) ABC grading system of psychometric propertie's reliability, validity, and responsiveness was used to evaluate the instruments. RESULTS: From the analysis of the psychometric properties of the three instruments, the SSI/SII appeared to have the best psychometric profile; Grade A, BFLUTS was of grade A, and KHQ was of grade B. SSI/SII had a good degree of internal consistency (Cronbach's alpha 0.74-0.78). BFLUTS and KHQ both had domains in which the internal consistency was <0.7. The SSI domain of the SSI/SII was the only domain to correlate to the 1-hr pad test. All domains of the SSI/SII were able to distinguish those cured from not cured and it was most responsive to change. Unlike the KHQ, the SSI/SII had no significant ceiling or floor effects. CONCLUSIONS: This study has demonstrated that when instruments are used in different populations their psychometric properties may change. All three instruments analyzed had limitations when used as an outcome measure for surgery for stress urinary incontinence.

How accurate is symptomatic and clinical evaluation of prolapse prior to surgical repair?

The aim of this study is to assess the accuracy of pre-operative evaluation of pelvic organ prolapse. The design is a prospective observational audit set at the gynaecology department, Teaching Hospital, UK. The population is composed of patients undergoing surgery for prolapse. One hundred and four patients admitted for prolapse surgeries were enrolled in the audit. Patients' notes were initially reviewed for adequacy of prolapse assessment in the clinic. Patients were then interviewed by the researchers and assessed using a validated Prolapse Quality of Life (P-QOL) questionnaire. The presence of unrecorded symptoms was noted. Prolapse examination in theatre under anaesthesia was compared to the findings in the clinic and the operation performed compared to the proposed operation. The outcome measures were as follows: (1) number of patients who had accurate prolapse symptom assessment before surgery when comparing clinical records with entries on P-QOL questionnaires; (2) number of patients having symptoms related to their pelvic organ prolapse that were not accurately assessed pre-operatively; and (3) the differences, if any, between pre-operative and intra-operative examination of prolapse. Sixteen patients in our cohort (15%) had adequate assessment of their prolapse pre-operatively. Symptoms that were not adequately assessed in descending order were the impact of prolapse on quality of life (76%), sexual function (75%), bowel function (27%) and lower urinary tract symptoms (12.5%). Thirty one patients (30%) had sexual dysfunction, 24 (23%) had bowel symptoms and 23 patients (22%) had urinary symptoms that were not recorded before surgery. Prolapse physical examination was adequate in 59% of the cases. Examinations in theatre were different from clinic findings in 38 cases (37%); 16 cases (42%) had a greater or lesser degree of prolapse than that described in the notes; and 11 cases (29%) had prolapse in a different compartment in the vagina. A combination of both (i.e. different degree of prolapse and prolapse in a different vaginal compartment) was found in another 11 cases (29%). The operation performed was different from the one proposed in the clinic in 21% of the cases (n=22). Clinical evaluation and examination of patients with vaginal prolapse is often inadequate. Prolapse physical examination in a clinic setting could be different from findings under anaesthesia. This can affect the operation to repair the prolapse. Patients should be counselled about this when listed for surgery.

Opening detrusor pressure and the influence of age on success following colposuspension.

OBJECTIVE: Women with urodynamic stress incontinence (USI) have lower opening and closing detrusor pressures than women without USI. This study was undertaken to determine whether a change occurs in opening and closing detrusor pressures after colposuspension, whether cure is associated with change, and whether age influences cure. DESIGN: Retrospective cohort study. SETTING: Tertiary referral urogynaecology department. PARTICIPANTS: Consecutive women who had undergone colposuspension between 1998-2000 and 1993-1995. METHODS: Pre- and post-operative urodynamic records were reviewed. Eighty eight women were included. Objective cure was defined as an absence of USI and subjective cure as an absence of symptoms of stress incontinence. RESULTS: Mean age was 52.4 (11.0) years. Sixty nine percent (61/88) were objectively cured and 48% (42/88) were subjectively cured. Postoperatively, opening detrusor pressure increased (P = 0.0001) and maximum flow rate decreased (P= 0.0464) in women objectively cured but these parameters did not change in the not cured group (P > 0.05). Women had a 4.5 times higher chance of failed surgery if post-op opening detrusor pressure was < or =20 cmH2O (P = 0.035). Opening detrusor pressure declined with age (P < 0.001) and women who were objectively cured were on average almost 7 years younger (P = 0.0330). CONCLUSIONS: Increase in opening detrusor pressure occurs only in women who are cured following colposuspension. Change in opening detrusor pressure is dependent on age and objective cure is higher in younger women. The effects of ageing on sub-urethral supports might explain why surgery is more likely to fail in older women.

Stress incontinence and pelvic floor neurophysiology 15 years after the first delivery.

UNLABELLED: HEADLINE: This is a longitudinal study of a cohort of primigravidae recruited between 1985 and 1987 and followed up 7 and 15 years later. Pelvic floor neurophysiology was performed and questionnaires were administered to determine the natural history of stress incontinence and to establish whether pelvic floor denervation after the first delivery is associated with symptoms of stress urinary incontinence in the future. OBJECTIVES: To study the natural history of stress urinary incontinence arising during the first pregnancy, to determine whether postnatal pelvic floor denervation progresses with time and whether it predisposes to stress urinary incontinence in the future. DESIGN: Prospective longitudinal cohort study. SETTING: Tertiary referral urogynaecology unit. SAMPLE: Cohort of 96 primigravidae studied prospectively between 1985 and 1987 and followed up 7 years (n = 76) and 15 years (n = 55) later. METHODS: Urinary incontinence symptoms were recorded and pelvic floor neurophysiology was performed antenatally and postnatally between 1985 and 1987. Repeat neurophysiological tests and questionnaires were completed by those relocated 7 and 15 years later. MAIN OUTCOME MEASURE: Symptoms of stress urinary incontinence. SECONDARY OUTCOMES: Symptoms of urge urinary incontinence and anal incontinence; motor unit potential duration and pudendal nerve terminal latency; vaginal squeeze pressure measured by perineometry. RESULTS: Prevalence of stress incontinence was highest during pregnancy and had increased seven years after the first postnatal period (P = 0.0129). Two-thirds of women with antenatal stress incontinence had stress incontinence 15 years later. One-third of women with stress incontinence at any time appear to undergo resolution of symptoms. Motor unit potential duration increased at seven years (P = 0.036). Vaginal squeeze pressure improved during the same period (P = 0.0007). CONCLUSIONS: When stress urinary incontinence arises during the first pregnancy, the risk of stress incontinence occurring 15 years later is doubled. Although pelvic floor reinnervation progressed after the postnatal period, the absence of an adequate marker for pelvic floor denervation makes it of uncertain clinical significance.