Patient experience of telephone consultations in gynaecology: a service evaluation.

OBJECTIVE: To investigate patient perspective of telephone consultations (TCs) in gynaecology and identify which patients benefit most from a telemedicine system. DESIGN: Service evaluation. SETTING: Gynaecology outpatient services at a tertiary referral hospital. POPULATION: Patients who received a TC during May and June 2020. METHODS: Postal questionnaire combining three validated tools: QQ-10, Patient Enablement Index (PEI) and National Health Service Friends and Family Test (NHS-FFT). Quantitative data and free text responses were analysed. MAIN OUTCOME MEASURES: Responses to QQ-10, PEI and NHS-FFT. RESULTS: In total, 1307 patients were contacted and 504 patients responded (39%). Most (89%) described their experience as 'Very good' or 'Good' (NHS-FFT). Positive themes from responses included 'convenience', 'effectiveness' and 'equivalent care'. QQ-10 responses demonstrated a high Value score of 79 (0-100) and a low Burden score of 15. PEI scores suggested that most patients felt better or much better able to understand and cope with their condition following TC. The majority of patients (77%) would 'Strongly agree' or 'Mostly agree' to a repeat TC. Regarding patient outcomes, 21% were discharged and 71% required follow up. Menopause, fertility and endometriosis follow-up clinic patients benefited most from TC. Gynaecology-oncology patients found TC least acceptable. CONCLUSION: We report a large questionnaire survey of patient experience of TC in gynaecology. Telemedicine is convenient, acceptable and effective for conducting care in selected groups. TC can support patients in communicating intimate symptoms. TWEETABLE ABSTRACT: Telephone consultations are a convenient, acceptable and effective medium for conducting patient care in gynaecology.

Does percutaneous tibial nerve stimulation improve global pelvic function in women with faecal incontinence?

AIM: Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive treatment for faecal incontinence. Many patients with faecal incontinence have coexisting pelvic floor disorders such as urinary incontinence and vaginal symptoms. We utilized a pelvic floor assessment tool to analyse any effect of PTNS on global pelvic floor function. METHODS: Patients with faecal incontinence attending our institution who had failed to respond sufficiently to biofeedback were offered a course of PTNS. Patients underwent pre- and post-stimulation assessment with a validated electronic Personal Assessment Questionnaire - Pelvic Floor (ePAQ-PF) for pelvic floor disorders. Scores were compared to assess the effect of treatment on global pelvic floor function. RESULTS: During the study period pre- and post-stimulation ePAQ-PF data were available for 60 patients (55% of all patients starting PTNS). In this cohort there was a significant improvement in bowel continence, bowel related quality of life, irritable bowel syndrome and bowel evacuation with a large effect size for continence and bowel related quality of life. There was also a significant improvement in non-bowel related symptoms, including urinary pain and stress incontinence, urinary related quality of life and bowel related sexual function. Sixty-five per cent of those who answered the question reported improvement in global health after stimulation. CONCLUSION: For patients presenting with faecal incontinence, PTNS appears to have a positive effect on bowel related function in approximately two-thirds of patients. However, for treatment responders, improvement appears to relate mainly to improvement in bowel related function rather than a global pelvic floor effect.

Does sacral nerve stimulation improve global pelvic function in women?

AIM: Many women undergoing sacral neuromodulation for faecal incontinence have coexisting pelvic floor dysfunction. We used a global pelvic-floor assessment questionnaire to evaluate the effect of sacral neuromodulation on non-bowel related symptomatology. METHOD: The electronic Personnel Assessment Questionnaire - Pelvic Floor (ePAQ-PF) is a validated Web-based electronic pelvic floor questionnaire. Women with faecal incontinence underwent assessment using the ePAQ. Pre- and poststimulator data were analysed over a 4.5-year period. RESULTS: Forty-three women (mean age 56.5 years; median follow up 6.8 months) were included. All (100%) had urinary symptoms, 81.4% had vaginal symptoms and 85.7% described some sexual dysfunction. There was a significant improvement in faecal incontinence and in bowel-related quality of life (P < 0.005) as well as in irritable bowel syndrome (IBS)-related symptoms (P < 0.01) and in bowel-related sexual heath (P < 0.01). Symptoms of vaginal prolapse significantly improved (P = 0.05). There was also improvement in symptoms of overactive bladder (P = 0.005) and in urinary-related quality of life (P < 0.05). A global health improvement was reported in 58.1%, mainly in bowel evacuation (P < 0.01) and in vaginal pain and sensation (P < 0.05). In sexually active female patients, significant improvements in vaginal and bowel-related sexual health were seen (P < 0.005). Improvement in general sex life following stimulation was reported in 53.3%. CONCLUSION: A Web-based electronic pelvic-floor assessment questionnaire has demonstrated global improvement in pelvic floor function in bowel, urinary, vaginal and sexual dimensions in women following sacral neuromodulation for faecal incontinence.

Development of an instrument to measure face validity, feasibility and utility of patient questionnaire use during health care: the QQ-10.

OBJECTIVE: To develop and establish the psychometric properties of an instrument to measure face validity, feasibility and utility of patient questionnaires used during health care. DESIGN: Our instrument, QQ-10, is a 10-item self-completed questionnaire, which was developed during the evaluation of another questionnaire (ePAQ-PF), to assess patients' views on questionnaire use during health care. SETTING: Urogynaecology Department, Royal Hallamshire Hospital, Sheffield, UK. PARTICIPANTS: The Sheffield maternity patient user group identified 10 key themes relating to patients' views on using questionnaires; these themes translated into 10 statements, each using the same 5-point Likert response scale. INTERVENTION: Not applicable. Outcome Measures Principal component analysis established the factor structure of our instrument. Internal reliability was assessed using Cronbach's alpha. Construct validity was assessed using Spearman's rho. RESULTS: Factor analysis yielded two meaningful factors: Value and Burden, both achieving Cronbach's alpha scores >0.7. Significant correlations were found between scores for Value and communication experience and between scores for Burden and barriers to health care. CONCLUSIONS: Our instrument offers a valid, reliable measure of patients' views relating to value and burden of using health-related quality of life questionnaires. Its two domains show good internal reliability and with its free text items, it may offer a valuable, standardized assessment of face validity and utility of other questionnaires used in health care.

Responsiveness of the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF).

This study aimed to evaluate the responsiveness of the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF) in women undergoing surgery for pelvic floor disorders. Fifty-four women undergoing tension-free vaginal tape (TVT) and 47 women undergoing prolapse surgery completed ePAQ-PF at baseline and 3 months postoperatively. Responsiveness was calculated using effect sizes, standardized response means, responsiveness statistic, and minimally important difference. In the TVT group, the largest effect sizes were seen in the urinary domains for stress urinary incontinence (2.4), quality of life (2.2), and overactive bladder (0.9). In the prolapse group, the largest effect sizes were seen in the vaginal domains for prolapse (2.1) and quality of life (1.0). ePAQ-PF is responsive to change in women undergoing TVT or prolapse surgery in the salient and expected domains of stress incontinence and prolapse and quality of life and can be recommended for outcome measurement in this context.

Electronic pelvic floor symptoms assessment: tests of data quality of ePAQ-PF.

The objective of the study was to test the data quality, scaling assumptions and scoring algorithms underlying the electronic personal assessment questionnaire-pelvic floor (ePAQ-PF). A cross-sectional survey of 599 women with pelvic floor disorders was carried out. Tests of data quality included secondary factor analysis, internal reliability, descriptive statistics, levels of missing data, floor and ceiling effects, item-to-total correlation scores, item discriminant and convergent validity. Secondary factor analysis verified the domain structure of ePAQ-PF. All 19 domains were internally reliable with Cronbach's alpha scores ranging from 0.71 to 0.93. Missing response rates ranged from 0.2% to 1.3%, and all items were found to be most highly correlated with their own corrected scale. Results confirmed the factor structure, data quality and scoring and scaling assumptions of ePAQ-PF, thereby verifying its suitability for measuring symptoms, bother and quality of life in women with pelvic floor disorders.

Criterion validity of the BBUSQ-22: a questionnaire assessing bowel and urinary tract symptoms in women.

To evaluate the criterion validity of the Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ-22). Forty-four women presenting with urinary or bowel symptoms to a urogynaecology/functional bowel clinic, completed three disease-specific questionnaires (Birmingham Bowel and Urinary Symptoms Questionnaire, Sheffield Prolapse Symptoms Questionnaire and King's Health Questionnaire) and two generic questionnaires (SF-36 and EuroQol). Wilcoxon rank sum tests, Spearman's rank correlations and multiple regression analyses were undertaken. All clinically hypothesised correlations between the questionnaires' domains were found significant, and all domains hypothesised to be predictors of the BBUSQ-22 domains were proven to be prognostic, without explaining too much variability to doubt their uniqueness. The similarity among the measures has been proved without such relationships being too strong to call into question the distinctiveness of the concepts being measured. Overall, criterion validity is demonstrated, and the clinical usefulness of the addition this questionnaire makes to the area is highlighted.

Questionnaires to assess urinary and anal incontinence: review and recommendations.

PURPOSE: We reviewed and provide recommendations about the most scientifically robust and appropriate questionnaires for evaluating symptoms and the quality of life impact of urinary and/or anal incontinence, and vaginal and pelvic floor problems. We also investigated the use of these questionnaires in randomized, controlled trials of treatment strategies. MATERIALS AND METHODS: The Symptom and Quality of Life Committee of the International Consultation on Incontinence performed a systematic review of questionnaires related to urinary and anal incontinence, and vaginal and pelvic floor problems, searching MEDLINE, The Cochrane Library and other electronic databases between 2001 and 2004. RESULTS: A total of 23 robust and relevant questionnaires could be recommended in clinical practice and research. The development of questionnaires to assess anal incontinence, and pelvic floor and vaginal problems has been limited with some promising measures but with none achieving the highest level of rigor. From 2001 to 2004 there were 150 published randomized trials of treatments for incontinence. Increasingly trials of incontinence are using recommended measures (38% of those for urinary incontinence and 22% of those for anal incontinence used the highest quality questionnaires in 2001 to 2004) but none of vaginal and pelvic floor problems used recommended questionnaires. CONCLUSIONS: With increasing acknowledgment of the value of patient based assessment much attention has been given to the development of questionnaires to assess symptoms and quality of life. Sufficient measures are now available for urinary incontinence, and researchers and clinicians are encouraged to use the 18 achieving the highest level of rigor and their validated translations. In contrast, the development of questionnaires for anal incontinence and pelvic/vaginal problems is in its infancy and further study in this area is needed. Randomized trials of treatments for incontinence should use only questionnaires achieving the highest level of scientific rigor.

Development and psychometric testing of a symptom index for pelvic organ prolapse.

A wide range of symptoms are commonly ascribed to pelvic organ prolapse including pain, awareness of lump, bowel, bladder and sexual dysfunction. The aim of this work was to develop and validate an instrument to quantify symptoms related to pelvic organ prolapse. Consultation with symptomatic women and specialists in coloproctology, urology, gynaecology and sexual health resulted in a questionnaire with 25 questions. In total, 203 women participated in a psychometric testing of this instrument, 152 cases with prolapse and 51 controls without. The content validity, criterion validity, reliability and responsiveness of the questionnaire were evaluated. The questionnaire proved a reliable and valid instrument for the assessment of symptoms related to uterovaginal prolapse. It is also sensitive to change.

Computer interviewing in urogynaecology: concept, development and psychometric testing of an electronic pelvic floor assessment questionnaire in primary and secondary care.

OBJECTIVE: To develop and evaluate a Web-based, electronic pelvic floor symptoms assessment questionnaire (e-PAQ)1 for women. DESIGN: A cross-sectional study in primary and secondary care. SETTING: Two general practices, two community health clinics and a secondary care urogynaecology clinic. SAMPLE: A total of 432 women (204 in primary care and 228 in secondary care) were recruited between June 2003 and January 2004. METHODS: The e-PAQ was located on a workstation (computer, touchscreen and printer). Women completed the e-PAQ prior to their appointment. Untreated women in primary care were asked to return seven days later to complete the e-PAQ a second time (test-retest). MAIN OUTCOME MEASURES: Factor analysis, reliability, validity, patient satisfaction, completion times and system costs. RESULTS: In secondary care, factor analysis identified 14 domains within the four dimensions (urinary, bowel, vaginal and sexual symptoms) with internal consistency (Cronbach's alpha)>or=0.7 in 11 of these. In primary care, alpha values were all>or=0.7 and test-retest analysis found acceptable intraclass correlations of 0.50-0.95 (P<0.001) for all domains. A measure of face validity and utility was gained using a nine-item questionnaire, which yielded strongly positive patient views on relevance and acceptability. CONCLUSIONS: The e-PAQ offers a user-friendly clinical tool, which provides valid and reliable data. The system offers comprehensive symptoms and quality of life evaluation and may enhance the clinical episode as well as the quality of care for women with pelvic floor disorders.

Serotonin-induced potentiation of cholinergic responses to electrical field stimulation in normal and neurogenic overactive human detrusor muscle.

OBJECTIVE: To compare the serotonin (5-HT)4-receptor-mediated effects of 5-HT on the potentiation of cholinergic responses to electrical-field stimulation (EFS) in isolated strips of detrusor muscle from patients with normal or neurogenic overactive bladders. MATERIAL AND METHODS: Strips of detrusor muscle were field-stimulated (10 Hz, 0.01 ms duration, 60 V for 5 s) at 100-s intervals until consistent responses were obtained. In the presence of methiothepin, ketanserin and ondansetron (all 1 mumol/L) to block 5-HT1, 5-HT2 and 5-HT3 receptors, respectively, the cumulative administration of 5-HT or the selective 5-HT4 agonist cisapride, produced concentration-dependent enhancement of responses to EFS in both types of tissue. RESULTS: The maximum potentiation induced by 5-HT in neurogenic overactive detrusor muscle was reduced (P < 0.05) by about half compared to normal detrusor muscle, but EC50 values obtained in normal and overactive tissue were not significantly different. Cisapride was less potent than 5-HT and acted as a partial agonist relative to 5-HT. The selective 5-HT4 receptor antagonist RS-100235 was a potent antagonist of the 5-HT-induced potentiation of responses to EFS. At 3 nmol/L RS-100235 antagonized the effects of 5-HT in both groups of tissues without affecting the maximum responses. The affinity estimates (apparent pKB values of 9.2-9.5) for this antagonist were similar in normal and overactive detrusor muscle. CONCLUSIONS: These results indicate that 5-HT4 receptor-mediated potentiation of field-stimulated responses is lower in the neurogenic overactive detrusor muscle than in normal tissue. 5-HT4 receptor antagonist affinity is unchanged in the neurogenic overactive bladder.

The acute effect of magnetic stimulation of the pelvic floor on involuntary detrusor activity during natural filling and overactive bladder symptoms.

OBJECTIVE: To evaluate the effect of magnetic stimulation of the pelvic floor (MSPF) on involuntary detrusor activity observed during natural filling, and on the overactive bladder symptom complex. PATIENTS AND METHODS: Eighteen women with detrusor overactivity on conventional cystometry underwent ambulatory urodynamic monitoring over two filling cycles. Fluid intake was standardized, provocative manoeuvres applied at regular intervals and symptoms documented contemporaneously. During the second filling cycle MSPF was delivered whenever the detrusor pressure increased by > 5 cmH2O. The women were subsequently treated with MSPF for 6 weeks; their lower urinary tract symptoms were assessed before and after treatment. RESULTS: Comparing the second (stimulated) cycle with the first (unstimulated) cycle, cystometric capacity was higher (373 vs 224 mL, P < 0.03). and involuntary detrusor activity of shorter duration (370 vs 427 s, P < 0.82) and lower amplitude (53 vs 63 cmH2O, P < or = 0.05). All women tolerated the procedure comfortably, but nine found it too time-consuming and withdrew. In the nine women who completed treatment there was no consistent change in overactive bladder symptoms. CONCLUSIONS: In this pilot study, MSPF during natural filling was associated with a decrease in the amplitude of involuntary detrusor contractions and a significant increase in cystometric capacity. However, MSPF had a variable effect on sensations of urgency, both acutely and after treatment, and currently there is no evidence to suggest that MSPF has an enduring effect on symptoms of the overactive bladder.

Development and validation of a questionnaire for the assessment of bowel and lower urinary tract symptoms in women.

OBJECTIVE: To develop a simple but sensitive instrument to evaluate and document symptoms of both bowel and urinary dysfunction in women. DESIGN: A 22-item questionnaire covering a range of bowel and urinary symptoms was developed and underwent rigorous psychometric testing. SETTING: The gynaecology departments of three hospitals, a urogynaecology clinic, a functional bowel clinic and a general practice. POPULATION: Six hundred and thirty women, comprising four groups: 1. women awaiting hysterectomy (n = 379), 2. women following hysterectomy (n = 45), 3. women referred with functional bowel and/or urinary symptoms (n = 65), 4. asymptomatic controls (n = 141). MAIN OUTCOME MEASURES: The content, construct and criterion validity, internal consistency, reliability and responsiveness of the questionnaire were measured. RESULTS Peer and patient reports and missing data patterns supported face and content validity. Factor analysis showed a clinically relevant four-factor structure with low content replication able to distinguish between patient groups, indicating good internal structure. Comparison with clinical, anorectal physiological, videoproctographic, transit time and urodynamic test results provide provisional indication of criterion validity. Key domain question analysis and Cronbach's alphas showed internal consistency. Kappa values demonstrated good test-retest reliability and key question correlation over time proved responsiveness. CONCLUSIONS: Our findings support the suitability, clinical validity, reliability and responsiveness of a simple questionnaire, which is sensitive to the constraints of clinical practice. The authors recommend its use in health care evaluation research assessing the effects of pelvic surgery and as a useful tool in comparing treatment efficacy.

A scoring system for the assessment of bowel and lower urinary tract symptoms in women.

OBJECTIVE: To develop a simple scoring system for a validated 22-item questionnaire used to assess bowel and urinary dysfunction in women. SETTING: A urogynaecology clinic, a functional bowel clinic, a district general hospital and a general practice. POPULATION: One hundred and one women referred with functional bowel and/or urinary symptoms and 131 asymptomatic controls. METHODS: A user manual has been prepared. Individual responses to questions are categorised into normal and abnormal and odds ratio tests applied to reflect their sensitivity. RESULTS: Scoring methods have been detailed, and appropriate and sensitive cutoff points defined. CONCLUSIONS: The use of this validated questionnaire is now aided by a user manual, facilitating health care evaluation research into the effects of pelvic surgery on pelvic floor symptomatology. A simple scoring system is provided, making the questionnaire a valuable and accessible research tool.

Conventional and ambulatory urodynamic findings in women with symptoms suggestive of bladder overactivity.

PURPOSE: We compared ambulatory urodynamics and conventional video cystometry findings in women with symptoms of bladder overactivity. MATERIALS AND METHODS: In a prospective randomized crossover study 106 women with symptoms of urinary urgency with or without incontinence were comprehensively investigated by video cystometry and ambulatory urodynamics in random order. In addition, all women completed a validated symptoms questionnaire and voiding diary. RESULTS: Involuntary detrusor activity was detected in 32 and 70 cases on video cystometry and ambulatory urodynamics, respectively (p <0.001). Video cystometry done according to International Continence Society standards diagnosed detrusor instability in 4 women with no involuntary detrusor activity on ambulatory urodynamics. Involuntary detrusor activity resulting in incontinence was observed in 39 cases on ambulatory urodynamics, including 20 (51%) with stable video cystometry results. Stress incontinence was diagnosed in 42 cases on video cystometry and in 34 on ambulatory urodynamics (p = 0.629). Increasingly severe urge and stress incontinence reported in the symptoms questionnaire correlated positively with the subsequent detection of detrusor overactivity and stress incontinence, respectively, on the 2 urodynamic tests. CONCLUSIONS: In contrast to video cystometry, ambulatory urodynamics provides objective evidence of clinically important bladder overactivity in the majority of women with symptoms suggestive of bladder overactivity. The correlation of symptoms with ambulatory urodynamic findings implies that greater reliance may be placed on symptomatic diagnosis of bladder overactivity. Improved objective assessment of detrusor function provided by ambulatory urodynamics has implications for the definition of bladder overactivity and relevance of conventional cystometry in this context. In women who complain of urgency stable conventional cystometrography findings should be interpreted with caution.

Transurethral implantation of macroplastique for the treatment of female stress urinary incontinence secondary to urethral sphincter deficiency.

OBJECTIVE: To assess the results of transurethral implantation of Macroplastique in women with stress incontinence secondary to urethral sphincter deficiency using subjective and objective outcome measures. METHODS: A total of 60 women with genuine stress incontinence secondary to intrinsic urethral sphincter deficiency were treated with transurethral implantation of Macroplastique. The patients had undergone a mean of 1.9 (range 0-7) previous episodes of continence surgery. Up to three treatment episodes were used, if necessary. The outcome was assessed by telephone interview (56 patients, mean follow-up period 19 months) and videocystometry (41 patients, mean follow-up period 16 months). Transurethral ultrasound scanning was performed in a further 9 patients. RESULTS: Symptomatically, 19.6% of the women interviewed by telephone considered themselves cured of their incontinence or were no longer using pads. A further 41.1% said their symptoms had significantly improved. Pad usage was reduced from a median of five to three pads per day (p < 0.001). Videocystometry in 41 women (mean follow-up period 16 months) was normal in 16 patients (39%) and showed genuine stress incontinence in 18 (43.9%) and detrusor instability in 12 patients (29.3%). Overall, 71.4% stated that they would undergo the procedure again under the same circumstances, and 80.4% would recommend this form of treatment to a friend with the same condition. Transurethral ultrasound scanning was performed in 9 patients (5 subjectively improved or cured, 1 patient with persistent symptoms but normal cystometry, and 3 patients with persistent genuine stress incontinence). Hyperechoic foci were seen surrounding the proximal urethra, consistent with implanted Macroplastique boluses. When completely encircling the urethra, the outcome was generally good. A total of 10 patients have undergone or are awaiting open surgery, and 3 are awaiting repeat implantation. CONCLUSION: Sustained improvement or cure of genuine stress incontinence has been achieved using Macroplastique in a large proportion of women with intrinsic sphincter deficiency, often following previous unsuccessful continence surgery. Transurethral ultrasound may prove to be a clinically useful imaging technique for the assessment and subsequent management of treatment failure following Macroplastique implantation.

Effect of methoxamine on maximum urethral pressure in women with genuine stress incontinence: a placebo-controlled, double-blind crossover study.

The aim of the study was to evaluate the potential role for a selective alpha1-adrenoceptor agonist in the treatment of urinary stress incontinence. A randomised, double-blind, placebo-controlled, crossover study design was employed. Half log incremental doses of intravenous methoxamine or placebo (saline) were administered to a group of women with genuine stress incontinence while measuring maximum urethral pressure (MUP), blood pressure, heart rate, and symptomatic side effects. Methoxamine evoked non-significant increases in MUP and diastolic blood pressure but caused a significant rise in systolic blood pressure and significant fall in heart rate at maximum dosage. Systemic side effects including piloerection, headache, and cold extremities were experienced in all subjects. The results indicate that the clinical usefulness of direct, peripherally acting sub-type-selective alpha1-adrenoceptor agonists in the medical treatment of stress incontinence may be limited by associated piloerection and cardiovascular side effects.