16 results on '"female urinary incontinence"'
Search Results
2. The tension-free vaginal tape operation : Is the inexperienced surgeon a risk factor? Learning curve and Swedish quality reference
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Nüssler, Emil K., Löfgren, Mats, Lindkvist, Håkan, Idahl, Annika, Nüssler, Emil K., Löfgren, Mats, Lindkvist, Håkan, and Idahl, Annika
- Abstract
Introduction: To reduce the risk of avoidable damage to the patient when training surgeons, one must predefine what standards to achieve, as well as supervise and monitor trainees' performance. The aim of this study is to establish a quality reference, to devise comprehensive tension-free vaginal tape (TVT) learning curves and to compare trainees' results to our quality reference. Material and methods: Using the Swedish National Quality Register for Gynecologic Surgery, we devised TVT learning curves for all Swedish TVT trainees from 2009 to 2017, covering their first 50 operations. These outcomes were compared with the results of Sweden's most experienced TVT surgeons for 14 quality variables. Results: In all, 163 trainees performed 2804 operations and 40 experienced surgeons performed 3482 operations. For our primary outcomes - perioperative bladder perforations and urinary continence after 1 year - as well as re-admission, re-operation and days to all daily living activities, there was no statistically significant difference between trainees and experienced surgeons at any time. For the first 10 trainee operations only, there were small differences in favor of the experienced surgeons: patient-reported minor complications after discharge (14% vs 18.4%, P = .002), 1-year patient-reported improvement (95.9% vs 91.8%, P < .000), and patient satisfaction (90.9% vs 86.2%, P = .002). For both trainee operations 1-10 and 11-50, compared with experienced surgeons, operation time (33.8 vs 22.2 min, P < .000; 28.3 vs 22.2 min, P < .000) and hospital stay time (0.16 vs 0.06 days, P < .001; 0.1 vs 0.06 days, P < .001) were longer, perioperative blood loss was higher (27.7 vs 24.4 mL, P = .001; 26.5 vs 24.4 mL, P = .004), and patient-reported catheterization within 8 weeks was higher (3.9% vs 1.8%, P < .000; 2.5% vs 1.8%, P = .001). One-year voiding difficulties for trainee patients (operations 1-10:14.2%, P = .260; operations 11-50:14.5%, P = .126) were com
- Published
- 2021
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3. Managing urinary incontinence in women - a review of new and emerging pharmacotherapy
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Bientinesi, Riccardo, Sacco, Emilio, Bientinesi R. (ORCID:0000-0003-0757-152X), Sacco E. (ORCID:0000-0003-4640-8354), Bientinesi, Riccardo, Sacco, Emilio, Bientinesi R. (ORCID:0000-0003-0757-152X), and Sacco E. (ORCID:0000-0003-4640-8354)
- Published
- 2018
4. Midlife Urinary Incontinence and the Intimate Dyad
- Author
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Meize-Grochowski, Robin, Tinkle, Melinda, Stuifbergen, Alexa, Rogers, Rebecca, Bedrick, Edward, Saiki, Lori Sue, Meize-Grochowski, Robin, Tinkle, Melinda, Stuifbergen, Alexa, Rogers, Rebecca, Bedrick, Edward, and Saiki, Lori Sue
- Subjects
- Corbin and Strauss Collaborative Chronic Illness Trajectory Model
- Abstract
Urinary incontinence is a major health concern for midlife women, with demonstrated effects on self-concept, life-style, and sexual function. The purpose of this study was to explore the effect of midlife female urinary incontinence on the intimate dyad from a chronic illness perspective. The Corbin and Strauss Collaborative Chronic Illness Trajectory Model identifies biographical and relationship work engaged in when coping with a chronic health condition in the context of an intimate relationship. The specific aims of this study were to explore potential associations among urinary incontinence symptom severity, relationship satisfaction, biographical work factors (self-esteem, body image, depression, anxiety), and relationship work factors (relational ethics, sexual quality of life, incontinence-related communication) for insights into the impact of female urinary incontinence on the intimate dyad. Community-based, purposive, snowball recruitment resulted in enrollment of 57 women and 43 partners who completed anonymous, mailed surveys. Quantitative data were collected through completion of established instruments chosen as operationalized measures of theoretically-derived concepts. Qualitative data were collected through open-ended questions. No significant associations were found between urinary incontinence symptom severity and relationship satisfaction, measures of biographical work, or measures of relationship work. Womens biographical variables and relationship variables demonstrated moderate to strong correlations with each other (with the exception of self-esteem and incontinence-related communication) and with relationship satisfaction. Partners' incontinence-related communication scores demonstrated moderate to strong correlations with all women's biographical measures and all partners' relationship measures. Regression analyses demonstrated significant, unique contributions of relational ethics, sexual quality of life, and women's depression to the vari
- Published
- 2015
5. Serum estradiol does not differentiate stress, mixed and urge incontinent women around menopause. A report from the Women's Health in the Lund Area (WHILA) study.
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Andrada, Maria, Källén, Karin, Lidfeldt, Jonas, Samsioe, Göran, Teleman, Pia, Andrada, Maria, Källén, Karin, Lidfeldt, Jonas, Samsioe, Göran, and Teleman, Pia
- Abstract
OBJECTIVE: To outline serum estradiol levels in perimenopausal women with stress, mixed or urge incontinence. We believe the majority of urgency symptoms in perimenopausal women to be caused by a pelvic floor dysfunction and a hypermobility of the bladder neck. If this is the case, there would be no difference in estradiol levels between the groups. STUDY DESIGN: Setting: University hospital. In the observational Women's Health in the Lund Area study, a subset of 400/2221 women reporting urinary incontinence completed a detailed questionnaire regarding lower urinary tract symptoms and had their serum steroid hormone levels measured. Statistical analyses were made by Chi-square test, nonparametrical tests, ANOVA, multi- and univariate logistic regression analysis. RESULTS: Stress incontinence was reported by 196, mixed incontinence by 153 and urge incontinence by 43 women; in 369, serumestradiol values were available. Serum estradiol did not differ significantly between stress incontinent (median 49.5pmo/l, range 2.63-875.4), urge incontinent (median 31.6pmol/l, range 2.63-460.7) or mixed incontinent women (median 35.5pmol/l, range 2.63-787.9, p=0.62). Logistic regression analysis correcting for age, parity, hormonal status, smoking, hysterectomy and BMI also failed to show any difference in estradiol levels between the groups (p=0.41-0.58). CONCLUSION: No significant differences in serum estradiol levels between stress, mixed or urge incontinent perimenopausal women could be demonstrated.
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- 2011
6. Frequency of de novo urgency in 463 women who had undergone the tension-free vaginal tape (TVT) procedure for genuine stress urinary incontinence-A long-term follow-up
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Holmgren, Corinne, Nilsson, Staffan, Lanner, Lars, Hellberg, Dan, Holmgren, Corinne, Nilsson, Staffan, Lanner, Lars, and Hellberg, Dan
- Abstract
Background To determine risk factors for the appearance of de novo urgency symptoms, and subsequent accompanying problems, after the tension-free vaginal tape (TVT) procedure in women with stress urinary incontinence. Method A structured preoperative analysis of the incontinence symptoms was made. A mailed questionnaire was distributed to 970 women that underwent the TVT procedure between 1995 and 2001. Average follow-up was 5.2 years (range 2–8 years). The questionnaire included specific questions on current urinary symptoms and incontinence. The disease-specific quality of life instruments IIQ-7 and UDI-6 were used to compare women with, and those without de novo urgency. Results Seven hundred and sixty women (78.3%) responded and 463 of those were identified as genuine stress incontinence preoperatively. De novo urgency occurred in 67 (14.5%) of the women. The frequency was similar irrespective of duration since the TVT procedure. The women that reported de novo urgency symptoms were compared with those without symptoms. Risk factors for occurrence of de novo urgency symptoms were older age (64.7 years versus 60.9 years; p
=
0.01), parity (2.6 versus 2.3; p
=
0.05), history of cesarean section (9.5% versus 2.5%; odds ratio 5.4), and history of recurrent urinary infections (29.7% versus 18.8%; odds ratio 1.6, but non-significant. De novo urgency had a severe impact on quality of life, as compared to the remaining study population. Conclusion Old age, parity and history of cesarean section were risk factors for de novo urgency after TVT surgery. Postoperative de novo urgency symptoms are as bothersome for the patient as the preoperative stress urinary incontinence.
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- 2007
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7. Evaluation of laparoscopic colposuspension and the tension-free vaginal tape procedure in the surgical treatment of female stress urinary incontinence
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Valpas, A. (Antti) and Valpas, A. (Antti)
- Abstract
Though not a life threatening condition, involuntary loss of urine is a miserable situation. It has a multidimensional effect on the afflicted individuals, both men and women — and for the society. The purpose of this study was to evaluate two modern, minimally invasive surgical techniques for the treatment of female stress urinary incontinence (SUI). The techniques evaluated were laparoscopic colposuspension with mesh and staples (LCM) and the tension-free vaginal tape procedure (TVT). The study consisted of four parts. The first part (Study I) was an observational retrospective follow-up study. Data on the first forty patients operated on with LCM at Oulu University Hospital were collected. Patients had SUI or mixed urinary incontinence (MUI) with predominantly stress incontinence. The Studies II–IV were parts of a randomized, multicenter clinical trial, where LCM was compared with TVT. According to the predefined inclusion criteria 128 SUI women were randomly allocated into two treatment groups: 70 patients received TVT treatment as allocated and 51 LCM. There were seven drop-outs after randomization. After one year of follow-up the cure and improvement rate of the patients operated with LCM were ~ 90%. Also a significant improvement was found in Urinary Incontinence Severity Scores (UISS). At base line the score was 12.1 and after one year follow-up 2.7 (p < 0.001). The bladder perforation rate was 15%. In Study II immediate cure rates and complications of LCM and TVT were studied. After six weeks of follow-up there was no difference in cure rates (~ 90%) between the procedures. There was no difference in complication rates. A significant difference was found in the use of anti-inflammatory / opioid drugs in the immediate post-operative period to relief the pain in favour for TVT. Hospital care was also significantly shorter after TVT than LCM. After one year of follow-up (Study III) TVT was found to give better result both objectively and subjective
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- 2005
8. Managing urinary incontinence across the lifespan
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Miller, Yvette D., Brown, Wendy J., Smith, Nadine, Chiarelli, Pauline, Miller, Yvette D., Brown, Wendy J., Smith, Nadine, and Chiarelli, Pauline
- Abstract
In the 1996 baseline surveys of the Australian Longitudinal Study of Women's Health (ALSWH), 36.1% of mid-age women (45-50) and 35% of older women (70-75) reported leaking urine. This study aimed to investigate (a) the range of self-management strategies used to deal with urinary incontinence (UI); (b) the reasons why many women who report leaking urine do not seek help for UI; and (c) the types of health professionals consulted and treatment provided, and perceptions of satisfaction with these, among a sample of women in each age group who reported leaking urine "often" at baseline. Five hundred participants were randomly selected from women in each of the mid-age and older cohorts of the ALSWH who had reported leaking urine "often" in a previous survey. Details about UI (frequency, severity, and situations), self-management behaviors and help-seeking for UI, types of health professional consulted, recommended treatment for the problem, and satisfaction with the service provided by health care professionals and the outcomes of recommended treatments were sought through a self-report mailed follow-up survey. Most respondents had leaked urine in the last month (94% and 91% of mid-age and older women, respectively), and 72.2% and 73.1% of mid-aged and older women, respectively, had sought help or advice about their UI. In both age groups, the likelihood of having sought help significantly increased with severity of incontinence. The most common reasons for not seeking help were that the women felt they could manage the problem themselves or they did not consider it to be a problem. Many women in both cohorts had employed avoidance techniques in an attempt to prevent leaking urine, including reducing their liquid consumption, going to the toilet "just in case," and rushing to the toilet the minute they felt the need to. Strategies are needed to inform women who experience UI of more effective management techniques and the possible health risks associated with common
- Published
- 2003
9. Att leva med urinläckage : En longitudinell populationsstudie om livskvalitet hos kvinnor och hur de hanterar sitt urinläckage
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Hägglund, Doris and Hägglund, Doris
- Abstract
Urinary incontinence is a prevalent condition; nevertheless few women seek professional help. One aim of this study was to investigate all women aged 18-70 years in a Swedish community regarding (a) the prevalence rate and risk factors of urine leakage and (b) the quality of life for women with and without urine leakage, for women with stress incontinence versus urge incontinence, and for women with urine leakage who had or had not sought help. A second aim was to study all women aged 18-46 years from the same population four years later regarding (a) the quality of life and natural history of urine leakage, (b) why some women with persistent urine leakage seek help and others do not, and (c) how they deal with their urine leakage. Every fourth woman aged 18-70 years was found to have urine leakage. The number of women with urine leakage increased with increasing age, the number of deliveries, the presence of urinary tract infection, and the use of oestrogen substitutions. Women with urine leakage had a lower quality of life in all eight dimensions of the SF-36 as compared with women without urine leakage. Furthermore, in women with urge incontinence the quality of life was lower compared with women with stress incontinence in all dimensions of the SF-36. Women with urine leakage who had sought help had lower quality of life in seven of eight SF-36 dimensions as compared with women with urine leakage who had not sought help. At the four-year follow-up the quality of life had deteriorated in five of eight SF-36 dimensions in women aged 18-46 years with persistent urine leakage as compared with women with persistent continence. The mean annual incidence and remission rates of urine leakage were on the same low level (4%). Most women with slight or moderate long-term urine leakage had not sought professional help, largely because they considered their leakage a minor problem. Pelvic floor exercises was the most commonly used management method for all participants.
- Published
- 2002
10. Five-year incidence and remission rates of female urinary incontinence in a Swedish population less than 65 years old
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Samuelsson, Eva C, Victor, F T Arne, Svärdsudd, Kurt F, Samuelsson, Eva C, Victor, F T Arne, and Svärdsudd, Kurt F
- Abstract
OBJECTIVE: We sought to determine the incidence and remission rates of urinary incontinence in a population-based sample of women. STUDY DESIGN: A total of 382 (87.6%) of 436 eligible women aged 20 to 59 years answered a questionnaire and underwent a gynecologic examination at baseline and were followed up approximately 5 years later. RESULTS: Urinary incontinence was present in 23.6% of women at baseline and in 27.5% at follow-up. The mean annual incidence rate of incontinence was 2.9%, and the mean annual incidence rate of incontinence weekly or more often was 0.5%. Women that were receiving estrogen at baseline were more likely than other women to have incontinence during follow-up. The mean annual remission rate among the 90 women who were incontinent at baseline was 5.9%. The annual net increase of incontinence in the study population was 0. 82%. CONCLUSION: Female urinary incontinence seems to be a dynamic condition with a relatively high rate of spontaneous remission, a fact of which physicians should be aware when assessing and planning prevention and treatment strategies.
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- 2000
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11. Urinary incontinence and genital prolapse : A prospective population-based study
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Samuelsson, Eva and Samuelsson, Eva
- Abstract
The aims of this study were to investigate the prevalence and possible determinants of urinary incontinence and genital prolapse and the natural course of urinary incontinence and its effect on well-being in a population-based sample of women aged 20 to 59 years. 491(77%) women participated in the baseline examination of a gynaecological health survey and 382 participated in a 5-year follow-up. The prevalence rate of urinary incontinence of any degree was 28% and of incontinence at least once a week 8.4%. Stress urinary incontinence was the dominant type. The prevalence rate was positively correlated to age, parity, smoking, estrogen replacement therapy and the presence of prolapse, and negatively correlated to the pelvic floor muscle strength. The mean annual incidence rate of any degree of incontinence was 2.9% and of incontinence weekly or more often 0.5%. The only factor significantly associated with onset of incontinence in a multivariate analysis was estrogen use at baseline. The mean annual remission rate was 5.9% and tended to decrease with increasing age and increasing severity of the incontinence. There was a strong correlation between how troublesome the women felt their leakage to be and the frequency of incontinence. Incontinent women rated their perceived health, sleep, fitness and satisfaction with their work situation lower than continent women and the rating was related to the frequency of incontinence. The prevalence of any degree of genital prolapse was 31%; only 2% had a prolapse that reached the introitus. Age, parity, pelvic floor muscle strength and, among parous women, the maximum birth weight were significantly and independently associated with presence of prolapse. Genital prolapse was mostly asymptomatic. Women who wanted treatment for their incontinence had more frequent incontinence, more often faecal incontinence and had poorer perceived well-being. One quarter of the incontinent women or 7% of the total population started treatment by
- Published
- 1999
12. A population study of urinary incontinence and nocturia among women aged 20-59 years : prevalence, well-being and wish for treatment
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Samuelsson, Eva, Victor, Arne, Tibblin, Gösta, Samuelsson, Eva, Victor, Arne, and Tibblin, Gösta
- Abstract
BACKGROUND: The aim was to study urinary incontinence (UI) and nocturia in a female population; prevalence, effect on well-being, wish for treatment and result of treatment in primary health care. METHODS: A postal questionnaire was sent to all women aged 20-59 years who were scheduled for gynecological health examination by midwives in a primary health care district during one year. Questions concerning well-being were based on the Gothenburg QOL instrument. All women with incontinence were offered treatment by a midwife and a family doctor. RESULTS: Of the included 641 women, 491 (77%) answered the questionnaire. The prevalence of urinary incontinence was 27.7%, 3.5% having daily leakage. Nocturia occurred in 32 women (6.5%), 12 of whom were also incontinent. Self-assessed health, sleep, fitness and satisfaction with work situation decreased significantly with increased frequency of incontinence. Well-being was not correlated to type of incontinence. Nocturia correlated to poor health and sleep. About a quarter of the incontinent women started treatment when offered and 80% of those who completed the treatment program were subjectively improved. Wish for treatment was directly correlated to frequency of incontinence but not to type. CONCLUSIONS: Urinary incontinence and nocturia affect well-being in a negative way. Well-being and wish for treatment correlate to frequency of incontinence but not to type of incontinence. Most women with UI accept it, only about a quarter of incontinent women, or 6-7% of all women in the studied age group, want treatment. Treatment of female urinary incontinence in primary health care is successful.
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- 1997
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13. Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial.
- Abstract
Introduction: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. Methods and analysis: This multicentre randomised controlled trial will compare the effectiveness and costeffectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. Ethics and dissemination: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed co
14. Effectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluation.
- Abstract
Introduction: Female urinary incontinence (UI) is common affecting up to 45% of women. Pelvic floor muscle training (PFMT) is the first-line treatment but there is uncertainty whether intensive PFMT is better than basic PFMT for long-term symptomatic improvement. It is also unclear which factors influence women’s ability to perform PFMT long term and whether this has impacts on long-term outcomes. OPAL (optimising PFMT to achieve long-term benefits) trial examines the effectiveness and cost-effectiveness of basic PFMT versus biofeedback-mediated PFMT and this evaluation explores women’s experiences of treatment and the factors which influence effectiveness. This will provide data aiding interpretation of the trial findings; make recommendations for optimising the treatment protocol; support implementation in practice; and address gaps in the literature around long-term adherence to PFMT for women with stress or mixed UI. Methods and analysis: This evaluation comprises a longitudinal qualitative case study and process evaluation (PE). The case study aims to explore women’s experiences of treatment and adherence and the PE will explore factors influencing intervention effectiveness. The case study has a two-tailed design and will recruit 40 women, 20 from each trial group; they will be interviewed four times over 2 years. Process data will be collected from women through questionnaires at four time-points, from health professionals through checklists and interviews and by sampling 100 audio recordings of appointments. Qualitative analysis will use case study methodology (qualitative study) and the framework technique (PE) and will interrogate for similarities and differences between the trial groups regarding barriers and facilitators to adherence. Process data analyses will examine fidelity, engagement and mediating factors using descriptive and interpretative statistics. Ethics and dissemination: Approval from West of Scotland Research Ethics Committee 4 (16/LO/0990
15. Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial.
- Abstract
Introduction: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. Methods and analysis: This multicentre randomised controlled trial will compare the effectiveness and costeffectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. Ethics and dissemination: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed co
16. Effectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluation.
- Abstract
Introduction: Female urinary incontinence (UI) is common affecting up to 45% of women. Pelvic floor muscle training (PFMT) is the first-line treatment but there is uncertainty whether intensive PFMT is better than basic PFMT for long-term symptomatic improvement. It is also unclear which factors influence women’s ability to perform PFMT long term and whether this has impacts on long-term outcomes. OPAL (optimising PFMT to achieve long-term benefits) trial examines the effectiveness and cost-effectiveness of basic PFMT versus biofeedback-mediated PFMT and this evaluation explores women’s experiences of treatment and the factors which influence effectiveness. This will provide data aiding interpretation of the trial findings; make recommendations for optimising the treatment protocol; support implementation in practice; and address gaps in the literature around long-term adherence to PFMT for women with stress or mixed UI. Methods and analysis: This evaluation comprises a longitudinal qualitative case study and process evaluation (PE). The case study aims to explore women’s experiences of treatment and adherence and the PE will explore factors influencing intervention effectiveness. The case study has a two-tailed design and will recruit 40 women, 20 from each trial group; they will be interviewed four times over 2 years. Process data will be collected from women through questionnaires at four time-points, from health professionals through checklists and interviews and by sampling 100 audio recordings of appointments. Qualitative analysis will use case study methodology (qualitative study) and the framework technique (PE) and will interrogate for similarities and differences between the trial groups regarding barriers and facilitators to adherence. Process data analyses will examine fidelity, engagement and mediating factors using descriptive and interpretative statistics. Ethics and dissemination: Approval from West of Scotland Research Ethics Committee 4 (16/LO/0990
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