G. Alessandro Digesu

The relationship of vaginal prolapse severity tosymptoms and quality of life

Objective  To assess the relationship and location of vaginal prolapse severity to symptoms and quality of life.

Identification of risk factors for genital prolapse recurrence.

To assess the relationship between prolapse recurrence and some risk factors in a group of women submitted to reconstructive pelvic surgery.

Validation of an Italian version of the prolapse quality of life questionnaire

OBJECTIVE To validate the italian translated version of the prolapse quality of life questionnaire (P-QOL). STUDY DESIGN The P-QOL questionnaire was translated into Italian and administered to women recruited from a gynaecology outpatient clinic. All women completed a P-QOL questionnaire at the time of the visit, and were examined in left lateral position using the ICS prolapse score. A second P-QOL questionnaire was posted and completed by women 1 week later. The validity was assessed by measuring levels of missing data, comparing symptom scores with objective prolapse stages and between affected and asymptomatic women. The reliability was assessed by testing internal consistency and stability using 1-week test retest analysis. RESULTS 132 symptomatic and 61 asymptomatic women were studied. The number of missing items was 2%. P-QOL domain scores were significantly different between symptomatic and asymptomatic women (P<0.001). Severity according to P-QOL strongly correlated with the prolapse size (P<0.01, rho>0.5). All items achieved a Cronbach alpha greater than 0.8. The test retest reliability confirmed a highly significant correlation between the total scores for each domain. CONCLUSION The Italian version of the P-QOL questionnaire has been validated, providing a reliable, easily comprehensible and valid instrument for the symptomatic assessment of Italian-speaking women with uterovaginal prolapse.

Reproducibility and reliability of pressure flow parameters in women

Objective The aim of this study was to evaluate the intra‐ and inter‐rater reliability of pressure flow parameters in women.

Three-dimensional ultrasound of the urethral sphincter predicts continence surgery outcome.

To assess the predictive value of three‐dimensional (3D) ultrasound volumes of the urethral sphincter in women undergoing continence surgery.

Do Women With Pure Stress Urinary Incontinence Need Urodynamics

OBJECTIVES To evaluate the value of performing urodynamic investigations in the assessment of women with a history of pure stress urinary incontinence (SUI). METHODS Consecutive women with lower urinary tract symptoms were studied retrospectively. Urinary symptoms were determined from the frequency-volume chart and symptom section of the Kings Health Questionnaire. Only women with pure SUI symptoms were included. RESULTS A total of 3428 women aged 24-81 years were studied. Only 308 women (8.9%) could be classified as having pure SUI from the questionnaire. Of these, 241 of women (78.2%) had urodynamic stress incontinence, 23 women (7.5%) had detrusor overactivity, 9 women (2.9%) had mixed urodynamic diagnosis, and 35 women (11.4%) had inconclusive urodynamics. Postvoid residual volumes greater than 100 mL were noted in 24 (7.8%) women. CONCLUSIONS Our results show that urodynamic investigations provide useful information in the assessment of women with a history of pure SUI, because as many as 20% of them might not need surgery as the first line of treatment.

Phase IIb, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Determine Effects of Elocalcitol in Women With Overactive Bladder and Idiopathic Detrusor Overactivity

OBJECTIVE To evaluate the efficacy and safety of elocalcitol in the treatment of women with overactive bladder and idiopathic detrusor overactivity. METHODS The study was a multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of women with overactive bladder symptoms recruited from 48 European tertiary referral centers. The participants were randomized to receive either placebo or elocalcitol, 75 μg/d or 150 μg/d for 4 weeks. A 3-day bladder diary, the Urgency Perception Scale, the Patients Perception of Bladder Condition, and urodynamics were used before and after treatment. Vital signs, laboratory blood tests, 24-hour urine collection, and electrocardiography were also performed to assess the safety. The analysis of covariance test was used to compare the treatment groups. The primary objective was to evaluate the change in bladder volume at the first involuntary detrusor contraction from baseline. RESULTS A total of 308 women were studied. No significant change was seen in the urodynamic parameters between the placebo and elocalcitol groups, except for the bladder volume at the first desire to void. The frequency of incontinence episodes was significantly reduced in the elocalcitol group compared with the placebo group (P = .02). The Patients Perception of Bladder Condition score improved significantly after treatment for the women receiving elocalcitol compared with those receiving placebo (P = .02). Treatment with both doses of elocalcitol was well tolerated, and no differences versus placebo were observed. CONCLUSION Although the primary endpoint was not achieved, elocalcitol appears to be an effective and well-tolerated drug for the treatment of women with overactive bladder and idiopathic detrusor overactivity. However, the multicenter setting for the use of urodynamics might have biased the results of our study.

Urogynaecology: Urethral retro‐resistance pressure and urodynamic diagnoses in women with lower urinary tract symptoms

Objective  This study determines whether the retrograde urethral retro‐resistance pressure (URP) measurement discriminates between urodynamic diagnoses in a group of women.

Ultrasound measurement of vaginal wall thickness: a novel and reliable technique

Introduction and hypothesisThe aim of this study was to validate a technique to measure the vaginal wall thickness (VWT) using two-dimensional ultrasound.MethodsWomen were scanned by two independent operators and by the same operator at two separate visits at the level of the bladder neck, the apex of the bladder, the anterior fornix, the anorectal junction, rectum and posterior fornix. Fresh female cadavers were scanned and ultrasound thickness of the vagina was compared to histological thickness.ResultsBland Altman analysis revealed a low mean difference between operators and between visits by the same operator. The 95% confidence intervals as a percentage of the mean vaginal wall thickness ranged between 2.8% and 7.4%. There was a low percentage difference between ultrasound and histological vaginal wall thickness.ConclusionUltrasound vaginal wall thickness demonstrated good intra- and interoperator reliability, as well as consistency with histological measurement. It is a valid technique.

Validity of the Rome III Criteria in assessing constipation in women

Introduction and hypothesisA study was conducted to validate a constipation questionnaire based on the Rome III criteria.MethodsWomen attending outpatient clinics completed a constipation questionnaire based on the Rome III Criteria. The internal reliability, the test–retest as well as the content and construct validity of the questionnaire were evaluated.ResultsTwo hundred one women were studied. Of the women, 28% (56/201) reported constipation but only 14% of these (8/56) could be defined as constipated accordingly to the Rome III Criteria. Nine percent of women (13/145) who did not report constipation were classified as constipated accordingly to the Rome III Criteria. The questionnaire had good reliability (Cronbach’s alpha of 0.85 and ICC of 0.85). However, the questionnaire did not have significant construct validity with patients’ self-report of constipation, stool frequency and stool form (Pearson chi-square P > 0.05).ConclusionsThe Rome III Criteria questionnaire is a reliable and reproducible tool but does not appear to be a valid instrument in diagnosing constipation.