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Self-Perceived Improvement in Bladder Health After Viewing a Novel Tutorial on Knack Use: A Randomized Controlled Trial Pilot Study.
Miller, JM, Hawthorne, KM, Park, L, Tolbert, M, Bies, K, Garcia, C, Misiunas, R, Newhouse, W, Smith, AR
Journal of women's health (2002). 2020;(10):1319-1327
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Abstract
Purpose: To test a novel bladder health tutorial on use of the Knack for overcoming bladder control challenges. The Knack-tutorial is a self-administered vignette-based instructional program on preempting bladder challenges in daily life (urgency, stress-leakage, or urge-leakage) through anticipatory, well-timed pelvic floor muscle contraction at the moment of challenge. Materials and Methods: This is a randomized controlled trial pilot test of 108 women with stress or mixed urinary incontinence. The Knack-tutorial group saw a 15-minute slide show with 10 vignettes portraying use of the Knack in daily life. The slide show format used inserted narrated videos, dubbed and animation enhanced pictures and cartoons, and automatic slide advancement. A control group saw a similarly constructed slide show on incorporating good diet/exercise habits. Outcomes were self-perceived improvement (yes/no, and as 0%-100%) 1 month after viewing the tutorial. Results: We enrolled 123 women, randomizing 64 to Knack-tutorial group and 59 to diet/exercise tutorial group. Eleven and one participant, respectively, did not return. Three did not fill out the self-perceived improvement report. Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group (p < 0.001). Self-perceived improvement was 21%-22% higher (Model I Est: 21.01, SE: 4.25, p < 0.001) in the Knack-tutorial group. Conclusions: An electronic tutorial viewed independent of a health care provider with vignettes showing Knack application to manage the everyday bladder challenges women face shows benefit of a magnitude that warrants more widespread use and rigorous testing. A professional remake of the intervention is now available (www.myconfidentbladder.com).
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Cranberries after pelvic floor surgery for urinary tract infection prophylaxis: A randomized controlled trial.
Mooren, ES, Liefers, WJ, de Leeuw, JW
Neurourology and urodynamics. 2020;(5):1543-1549
Abstract
AIMS: Urinary tract infection (UTI) is a common complication after pelvic floor surgery. Antibiotics as prophylaxis may reduce the prevalence of UTI's by 50%, but bacterial resistance may be a large disadvantage, necessitating the search for other possible prophylactic options. Recent research found a 50% reduction in the rate of UTI's with the use of cranberry capsules after elective gynecologic surgery, suggesting that cranberry capsules may serve as a good prophylaxis. The aim of this study was to assess whether perioperative cranberry prophylaxis reduces the risk of clinical overt UTI after elective pelvic floor surgery with indwelling catheter. METHODS We conducted a single-center randomized, double-blind, placebo-controlled trial. Women were given cranberry capsules twice daily or identical placebo for 6 weeks, starting the day before surgery. The main endpoint of the trial was the incidence of UTI within 6 weeks after surgery, defined as clinical diagnosis and treatment of UTI by the medical doctor. Analyses were performed with the intention to treat. RESULTS Two hundred ten participants were included, 105 in each arm. There was no significant difference in the prevalence of UTI between the cranberry arm (n = 13, 12.4%) and the placebo arm (n = 21, 20.0%; P = .13), but the prevalence in both arms was lower than anticipated. CONCLUSIONS This trial shows no beneficial effect of adequately dosed cranberry prophylaxis in women undergoing pelvic floor surgery, although such effect cannot be ruled out in settings with a higher prevalence of UTI's.
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Pelvic Floor Muscle Training With Or Without Tibial Nerve Stimulation and Lifestyle Changes Have Comparable Effects on The Overactive Bladder. A Randomized Clinical Trial.
Bykoviene, L, Kubilius, R, Aniuliene, R, Bartuseviciene, E, Bartusevicius, A
Urology journal. 2018;(4):186-192
Abstract
PURPOSE To compare effects of transcutaneous posterior tibial nerve stimulation (TPTNS) and pelvic floor muscle training (PFMT) in women with overactive bladder syndrome (OAB). MATERIAL AND METHODS We randomized 67 women ? 18 years with OAB to three parallel groups: group I (n = 22) received life-style recommendations (LSR) only; group II (n = 24) had LSR + PFMT and group III (n = 21) had LSR + PFMT + TPTNS. Urgency, evaluated by a 3-day voiding diary before treatment and six weeks later, was the main outcome measure. The King's College Health Questionnaire was also administered. RESULTS Urgency was significantly reduced in all three groups from 5.1 ± 3.7 to 3.8 ± 3.2 episodes/day, P = .016 in group I, from 5.2 ± 3.6 to 3.2 ± 2.9, P = .006 in group II and from 6.8 ± 3.1 to 4.4 ± 3.5 in group III, P = .013. There were no intergroup differences. The questionnaire results improved significantly only in group III as regards general health perception, role limitation, physical and social limitations without intergroup differences. Womenimproved their micturition frequency in two groups from 8.9 ± 3.2 to 7.5 ± 2.3 episodes/per day, P = .025 in group II, and from 8.8 ± 2.3 to 7.4 ± 2.0, P = .001 in group III, but only in group II was a significant reduction of urinary incontinence seen from 3.8 ± 4.6 to 2.9 ± 4.8 episodes/day, P = .045. CONCLUSION All three treatments lead to effective short-term reduction of urgency in women with OAB, but longterm efficacy evaluation is required.
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Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial.
Lausen, A, Marsland, L, Head, S, Jackson, J, Lausen, B
BMC women's health. 2018;(1):16
Abstract
BACKGROUND Urinary incontinence (UI) is a distressing condition affecting at least 5 million women in England and Wales. Traditionally, physiotherapy for UI comprises pelvic floor muscle training, but although evidence suggests this can be effective it is also recognised that benefits are often compromised by patient motivation and commitment. In addition, there is increasing recognition that physical symptoms alone are poor indicators of the impact of incontinence on individuals' lives. Consequently, more holistic approaches to the treatment of UI, such as Modified Pilates (MP) have been recommended. This study aimed to provide preliminary findings about the effectiveness of a 6-week course of MP classes as an adjunct to standard physiotherapy care for UI, and to test the feasibility of a randomised controlled trial (RCT) design. METHODS The study design was a single centre pilot RCT, plus qualitative interviews. 73 women referred to Women's Health Physiotherapy Services for UI at Colchester Hospital University NHS Foundation Trust were randomly assigned to two groups: a 6-week course of MP classes in addition to standard physiotherapy care (intervention) or standard physiotherapy care only (control). Main outcome measures were self-reported UI, quality of life and self-esteem at baseline (T1), completion of treatment (T2), and 5 months after randomisation (T3). Qualitative interviews were conducted with a subgroup at T2 and T3. Due to the nature of the intervention blinding of participants, physiotherapists and researchers was not feasible. RESULTS Post-intervention data revealed a range of benefits for women who attended MP classes and who had lower symptom severity at baseline: improved self-esteem (p = 0.032), decreased social embarrassment (p = 0.026) and lower impact on normal daily activities (p = 0.025). In contrast, women with higher symptom severity showed improvement in their personal relationships (p = 0.017). Qualitative analysis supported these findings and also indicated that MP classes could positively influence attitudes to exercise, diet and wellbeing. CONCLUSIONS A definitive RCT is feasible but will require a large sample size to inform clinical practice. TRIAL REGISTRATION ISRCTN74075972 Registered 12/12/12 (Retrospectively registered).
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Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial.
Norton, C, Emmanuel, A, Stevens, N, Scott, SM, Grossi, U, Bannister, S, Eldridge, S, Mason, JM, Knowles, CH
Trials. 2017;(1):139
Abstract
BACKGROUND Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice. METHODS/DESIGN A three-arm, parallel-group, multicentre randomised controlled trial. OBJECTIVES to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation-Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience. HYPOTHESES (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST). Inclusion: chronic constipation in adults (aged 18-70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis. DISCUSSION This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone. TRIAL REGISTRATION International Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015.
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The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery: A Randomized Controlled Trial.
Adelowo, AO, Hacker, MR, Modest, AM, Apostolis, CA, Disciullo, AJ, Hanaway, KJ, Elkadry, EE, Rosenblatt, PL, Rogers, KJ, Hota, LS
Female pelvic medicine & reconstructive surgery. 2017;(1):1-7
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Abstract
OBJECTIVE To compare mechanical bowel preparation (MBP) using oral magnesium citrate with sodium phosphate enema to sodium phosphate (NaP) enema alone during minimally invasive pelvic reconstructive surgery. METHODS We conducted a single-blind, randomized controlled trial of MBP versus NaP in women undergoing minimally invasive pelvic reconstructive surgery. The primary outcome was intraoperative quality of the surgical field. Secondary outcomes included surgeon assessment of bowel handling and patient-reported tolerability symptoms. RESULTS One hundred fifty-three participants were enrolled; 148 completed the study (71 MBP and 77 NaP). Patient demographics, clinical and intraoperative characteristics were similar. Completion of assigned bowel preparation was similar between MBP (97.2%) and NaP (97.4%). The MBP group found the preparation more difficult (P<0.01) and reported more overall discomfort and negative preoperative side effects (all P≤0.01). Quality of surgical field at initial port placement was excellent/good in 80.0% of the MBP group compared with 62.3% in the NaP group (P=0.02). This difference was not maintained by the conclusion of surgery (P=0.18). Similar results were seen in the intent-to-treat population. Surgeons accurately guessed preparation 65.7% of the time for MBP versus 41.6% for NaP (P=0.36). At 2 weeks postoperatively, both reported a median time for return of bowel function of 3.0 (2.0-4.0) days. CONCLUSIONS Mechanical bowel preparation with oral magnesium citrate before minimally invasive pelvic reconstructive surgery offered initial improvement in the quality of surgical field, but this benefit was not sustained. It was associated with an increase in patient discomfort preoperatively, but did not seem to impact postoperative return of bowel function. LEVEL OF EVIDENCE I.
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Effectiveness of adding voluntary pelvic floor muscle contraction to a Pilates exercise program: an assessor-masked randomized controlled trial.
Torelli, L, de Jarmy Di Bella, ZI, Rodrigues, CA, Stüpp, L, Girão, MJ, Sartori, MG
International urogynecology journal. 2016;(11):1743-1752
Abstract
INTRODUCTION AND HYPOTHESIS The purpose of this study was to evaluate the effectiveness of adding voluntary pelvic floor muscle contraction (PFMC) to a Pilates exercise program in sedentary nulliparous women. METHODS Fifty-seven healthy nulliparous and physically inactive women were randomized to a Pilates exercise program (PEP) with or without PFMC. Forty-eight women concluded this study (24 participants for each group). Each woman was evaluated before and after the PEP, by a physiotherapist and an urogynecologist (UG). Neither of the professionals was revealed to them. This physiotherapist measured their pelvic floor muscle strength by using both a perineometer (Peritron) and vaginal palpation (Oxford Scale). The UG, who performed 3D perineal ultrasound examinations, collected their data and evaluated the results for pubovisceral muscle thickness and the levator hiatus area (LA). Both professionals were blinded to the group allocation. The protocol for both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises, developed by another physiotherapist who specializes in PFM rehabilitation and the Pilates technique. RESULTS The PEP+ PFMC group showed significantly greater strength improvements than the PEP group when comparing the Oxford scale, vaginal pressure and pubovisceral muscle thickness during contraction measurements at baseline and post-treatment. CONCLUSIONS Our findings suggest that adding a voluntary PFMC to a Pilates exercise program is more effective than Pilates alone in improving PFM strength in sedentary nulliparous women.
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Lifestyle advice with or without pelvic floor muscle training for pelvic organ prolapse: a randomized controlled trial.
Due, U, Brostrøm, S, Lose, G
International urogynecology journal. 2016;(4):555-63
Abstract
INTRODUCTION AND HYPOTHESIS We evaluated the effect of adding pelvic floor muscle training (PFMT) to a structured lifestyle advice program. METHODS This was a single-blinded randomized trial of women with symptomatic pelvic organ prolapse (POP) stage ≥ II. Participants were randomized to a structured lifestyle advice program with or without PFMT. Both groups received similar lifestyle advice in six separate group sessions. The combined group performed group PFMT after an individual assessment. Primary outcome was a global improvement scale at six-month follow-up. Secondary outcomes were the global scale and objective POP at three-month follow-up, symptoms and quality of life including sexuality, at three and six-month follow-up. A clinically relevant change of symptoms was defined as ≥ 15 %. RESULTS We included 109 women. Eighty-nine women (82 %) completed three months follow-up; 85 (78 %) completed six-month follow-up. At both follow-ups, significantly more women in the combined group reported improvement in the global scale. At the three-month follow-up, the combined group only had significant improvement of POP symptoms while only the lifestyle advice group had significant improvement of quality of life. Change in objective POP and sexuality was nonsignificant. The symptom score improved 17 % in the combined group and 14 % in the lifestyle advice group (P = 0.57). Significantly more women in the lifestyle advice group had sought further treatment at the six-month follow-up. CONCLUSION Adding PFMT to a structured lifestyle advice program gave superior results in a global scale and for POP symptoms. Overall effect of either intervention barely reached clinical relevance.
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Combined functional pelvic floor muscle exercises with Swiss ball and urotherapy for management of dysfunctional voiding in children: a randomized clinical trial.
Ladi Seyedian, SS, Sharifi-Rad, L, Ebadi, M, Kajbafzadeh, AM
European journal of pediatrics. 2014;(10):1347-53
Abstract
UNLABELLED We report the clinical results of two types of urotherapy programs in children with dysfunctional voiding (DV). Sixty children with a median age of 8 (range, 5-14) diagnosed with DV were randomly allocated to one of two groups, each made up of 30 patients. Patients in group A underwent behavioral urotherapy (hydration, scheduled voiding, toilet training, and high-fiber diet) combined with pelvic floor muscle (PFM) exercises, whereas group B only received behavioral urotherapy. All parents completed a voiding and bowel habit diary chart. Uroflowmetry with pelvic floor surface electromyography (EMG) and bladder ultrasound were performed on all patients at the beginning and the end of the 1-year study. Abnormal voiding pattern normalized to a bell shape in 21/30 of patients in group A and 8/30 of patients in group B (P < 0.000). EMG activity during voiding disappeared significantly in 23/30 patients in group A compared to 15/30 patients in group B (P < 0.02). Episodes of urgency resolved in 12/14 of patients in group A and 3/11 of patients in group B (P < 0.01). Daytime wetting improved in 15/17 and 4/11 of patients in groups A and B, respectively. In addition, reduction in post-void residue (PVR) was significant in group A (P < 0.003). CONCLUSION Functional PFM exercises with Swiss ball combined with behavioral urotherapy proved as a safe and effective therapeutic modality, reducing the frequency of urinary incontinence, PVR, and the severity of constipation in children with DV.
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Rectal balloon training as add-on therapy to pelvic floor muscle training in adults with fecal incontinence: a randomized controlled trial.
Bols, E, Berghmans, B, de Bie, R, Govaert, B, van Wunnik, B, Heymans, M, Hendriks, E, Baeten, C
Neurourology and urodynamics. 2012;(1):132-8
Abstract
AIMS: Fecal incontinence (FI) is embarrassing, resulting in poor quality of life. Rectal sensation may be more important than sphincter strength to relieve symptoms. A single-blind, randomized controlled trial among adults with FI compared the effectiveness of rectal balloon training (RBT) and pelvic floor muscle training (PFMT) versus PFMT alone. METHODS We randomized 80 patients, recruited from the Maastricht University Medical Centre. Primary outcome was based on the Vaizey score. Secondary outcomes were the Fecal Incontinence Quality of Life Scale (FIQL), 9-point global perceived effect (GPE) score, anorectal manometry, rectal distension volumes, and thresholds of anorectal sensation. Analyses were by intention-to-treat. RESULTS Forty patients were assigned to combined RBT with PFMT and 40 to PFMT alone. Adding RBT did not result in a significant improvement in the Vaizey score [mean difference: -1.19; 95% confidence interval (CI): -3.79 to 1.42; P = 0.37]. Secondary outcomes favoring RBT were: Lifestyle subscale of the FIQL (0.37; 95% CI: 0.02-0.73; P = 0.04), GPE (-1.01; 95% CI: -1.75 to -0.27; P = 0.008), maximum tolerable volume (49.35; 95% CI: 13.26-85.44; P = 0.009), and external anal sphincter fatigue (0.65; 95% CI: 0.26-1.04; P = 0.001). Overall, 50% of patients were considered improved according to the estimated minimally important change (Vaizey change ≥-5). CONCLUSIONS RBT with PFMT was equally effective as PFMT alone. Secondary outcomes show beneficial effects of RBT on urgency control, GPE, and lifestyle adaptations. Characteristics of patients who benefit most from RBT remain to be confirmed.