Vaginal pressure sensor measurement during maximal voluntary pelvic floor contraction correlates with vaginal birth and pelvic organ prolapse-A pilot study.

AIMS: To measure the force applied along the anterior and posterior vaginal walls in a cohort of 46 patients measured by a fiber-optic pressure sensor and determine if this correlates with vaginal parity and pelvic organ prolapse (POP). METHODS: An intravaginal fiber-optic sensor measured pressure at nine locations along the anterior and posterior vaginal walls during a maximal voluntary pelvic floor muscle contraction (MVC). An automated probe dilation cycle measured the tissue resistance incorporating the vagina and surrounding anatomy. MVC and resting tissue resistance (RTR) were assessed between subjects grouped by the number of vaginal births and prolapse stage. RESULTS: A previous vaginal birth was associated with a significant threefold decrease in the overall anterior pressure measurement during MVC. Decreased anterior pressure measurements were observed at Sensors 1 and 3 (distal vagina) and, posteriorly at Sensors 4-6 (midvagina). Women with Stage 2 posterior prolapse exhibited a decreased MVC pressure in the midvagina than those with Stage 0/1. In this pilot study, there was no difference in the vaginal wall RTR according to previous vaginal birth or stage of prolapse. CONCLUSION: This pilot study found that a decrease in vaginal pressure measured during MVC is associated with vaginal birth and with posterior POP. Greater sample size is required to assess the role of resting tissue pressure measurement.

Hysterectomy with uterosacral suspension or Uphold™ hysteropexy in women with apical prolapse: a parallel cohort study.

INTRODUCTION AND HYPOTHESIS: The aim was to compare objective and subjective cure rates between Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension. METHODS: A sample size of 49 in each arm would be required to detect a clinical difference of 20% between the groups. Owing to delayed recruitment, this originally planned randomised controlled trial was changed to a patient preference study after randomising initial 6 participants. Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included. Routine follow-up was scheduled at 6 weeks, 6 months, 12 months, and annually thereafter. Primary outcome was absence of stage ≥2 apical prolapse. Secondary outcomes included a composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes were based on quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score). RESULTS: We recruited 50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016. Participants were followed up for a median of 25 months (23-96). Five women from the VH (10%) and 7 from the HP (14%) group were lost to follow-up. Combined anatomical and symptomatic outcomes were available for 41 (82%) VH and 39 (76%) in the HP group. There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50). We found no difference in the composite cure rate (78% VH vs 85% HP, 0.45) between the groups. There was no significant difference in surgical complications (p = 0.33), assessed using Clavien-Dindo classification. There was a 2% surgery rate for mesh exposure in the HP group. CONCLUSIONS: Uphold™ uterine suspension and VH appear to have similar objective and subjective cure at 25 months, with no significant difference in surgical complications.

Obesity: how much does it matter for female pelvic organ prolapse?

INTRODUCTION AND HYPOTHESIS: The objective was to determine the association between body mass index (BMI) and symptoms and signs of female pelvic organ prolapse (POP). METHODS: An observational cross-sectional study of 964 archived datasets of women seen for symptoms and signs of lower urinary tract and pelvic organ dysfunction between September 2011 and February 2014 at a tertiary urogynaecology centre in Australia was carried out. An in-house standardised interview, the International Continence Society Pelvic Organ Prolapse Quantification (ICS POP-Q) and 4-D translabial ultrasound, followed by analysis of ultrasound volumes for pelvic organ descent and hiatal area on Valsalva, were performed, blinded against other data. RESULTS: There is a positive association between BMI and posterior compartment prolapse on clinical examination and ultrasound imaging, but not for the anterior and central compartments. There was no association with prolapse symptom bother and a negative association with symptoms of prolapse. CONCLUSIONS: In this observational study, we found a strong association between all tested measures of posterior compartment descent and BMI, both clinical and on imaging.

Vaginal wall weakness in parous ewes: a potential preclinical model of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Ewes develop pelvic organ prolapse (POP) and may be a suitable model for preclinical studies evaluating cell-based therapies for POP. The aim of this study was to establish a clinical score of vaginal weakness and to compare POP Quantification System (POP-Q) values in conscious nulliparous and parous ewes and determine whether ewes are a suitable POP model. METHODS: Ewes (n = 114) were examined while conscious, without sedation, and standing in a V conveyer by adapting the human POP-Q measurement. Ovine POP was defined as descent to the introitus from POP-Q points Aa 3 cm above the introitus on the anterior wall, Ap 3 cm above the introitus on the posterior wall, or increased Ba anterior wall descent above the urethra (≥0). A test-retest showed good inter- and intrarater reliability. RESULTS: There was no evidence of tissue mobility at Aa, Ap, Ba (all -3 cm) in nulliparous ewes (n = 14). In contrast, multiparous ewes had a median of -1 and interquartile range (IQR) (-2 to 0) for Aa, [0 (-1 to 0)] for Ap and [0 (-2.75 to 0)] for Ba (n = 33; P < 0.0001 in comparison with nulliparous) ewes. Ovine vaginal displacement was seen in 50.9 % of parous ewes and was strongly associated with parity (P = 0.003). CONCLUSIONS: A modified POP-Q in conscious ewes was established showing that the vaginal wall of parous animals has similar regions of weakness as do women and may be similarly related to parity. Ewes appear to be a representative preclinical model of human vaginal prolapse.

TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial.

INTRODUCTION: Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up. OBJECTIVE: To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence. METHODS: Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were analysed statistically. RESULTS: Between February 2011 and January 2016,a total of 246 women were randomized to receive MiniArc (121) or TVT Abbrevo (125). Baseline characteristics were clinically balanced in both groups. At 6 months subjective (94.4% vs 95.7% p=0.74) and Objective (92.9% vs 95.9% p=0.49) cure rates were high and not statistically different. At 12 months there were also no differences in subjective (73.6% vs 76.9% p=0.73) or objective (90.5% vs 96.0% p=0.21) cure rates. No differences were found in functional outcomes or when adjusted for potential confounding factors such as age, parity, BMI or menopausal status. CONCLUSION: We found no significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo.

Ovine multiparity is associated with diminished vaginal muscularis, increased elastic fibres and vaginal wall weakness: implication for pelvic organ prolapse.

Pelvic Organ Prolapse (POP) is a major clinical burden affecting 25% of women, with vaginal delivery a major contributing factor. We hypothesised that increasing parity weakens the vagina by altering the extracellular matrix proteins and smooth muscle thereby leading to POP vulnerability. We used a modified POP-quantification (POP-Q) system and a novel pressure sensor to measure vaginal wall weakness in nulliparous, primiparous and multiparous ewes. These measurements were correlated with histological, biochemical and biomechanical properties of the ovine vagina. Primiparous and multiparous ewes had greater displacement of vaginal tissue compared to nulliparous at points Aa, Ap and Ba and lower pressure sensor measurements at points equivalent to Ap and Ba. Vaginal wall muscularis of multiparous ewes was thinner than nulliparous and had greater elastic fibre content. Collagen content was lower in primiparous than nulliparous ewes, but collagen organisation did not differ. Biomechanically, multiparous vaginal tissue was weaker and less stiff than nulliparous. Parity had a significant impact on the structure and function of the ovine vaginal wall, as the multiparous vaginal wall was weaker and had a thinner muscularis than nulliparous ewes. This correlated with "POP-Q" and pressure sensor measurements showing greater tissue laxity in multiparous compared to nulliparous ewes.

Real-time measurement of the vaginal pressure profile using an optical-fiber-based instrumented speculum.

Pelvic organ prolapse (POP) occurs when changes to the pelvic organ support structures cause descent or herniation of the pelvic organs into the vagina. Clinical evaluation of POP is a series of manual measurements known as the pelvic organ prolapse quantification (POP-Q) score. However, it fails to identify the mechanism causing POP and relies on the skills of the practitioner. We report on a modified vaginal speculum incorporating a double-helix fiber-Bragg grating structure for distributed pressure measurements along the length of the vagina and include preliminary data in an ovine model of prolapse. Vaginal pressure profiles were recorded at 10 Hz as the speculum was dilated incrementally up to 20 mm. At 10-mm dilation, nulliparous sheep showed higher mean pressures ( 102 ± 46 ?? mmHg ) than parous sheep ( 39 ± 23 ?? mmHg ) ( P = 0.02 ), attributable largely to the proximal (cervical) end of the vagina. In addition to overall pressure variations, we observed a difference in the distribution of pressure that related to POP-Q measurements adapted for the ovine anatomy, showing increased tissue laxity in the upper anterior vagina for parous ewes. We demonstrate the utility of the fiber-optic instrumented speculum for rapid distributed measurement of vaginal support.

Outcomes of patients who declined randomization to MiniMo trial.

OBJECTIVE: To evaluate lower urinary tract outcomes of eligible women who declined randomization to MiniArc(®) versus Monarc™ (MiniMo) RCT. To explore reasons why eligible women declined participation. STUDY DESIGN: The medical records of 44 women who declined randomization to MiniMo were reviewed. Women had a phone questionnaire at a mean of 2.4 years after surgery (range 1.3-3.9) and asked to document their symptoms at 6 and 12 months after operation, if they had not attended previously. Objective cure was defined as a negative cough stress test. Subjective cure was defined as patient reporting no leak on cough, sneeze or exercise. Outcomes of patients who declined were compared with those who participated in the MiniMo RCT. Women were asked to outline their reasons for declining participation in the MiniMo RCT. RESULTS: Baseline characteristics were similar except for BMI, which was higher in the declined group compared to the randomized group. Subjective cure at 6 months (79% vs. 94%, p=0.01) and 12 months was significantly lower in the declined group (58% vs. 93%, p<0.001). The commonest reason for declining participation in this study was the requirement for additional follow up. CONCLUSIONS: Results of RCTs may be overstated compared to standard clinical care as seen in this study.