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Improvement in Quality of Life with Pelvic Floor Muscle Training and Biofeedback in Patients with Painful Bladder Syndrome/Interstitial Cystitis.

ABSTRACT: To prove the benefits of pelvic floor muscle training with biofeedback (BFB) as a complementary treatment in women with bladder pain syndrome/interstitial cystitis (BPS/IC). Prospective, randomized study in 123 women with BPS/IC. Groups: BFB+ (n = 48): women with oral drug treatment (perphenazine and amitriptyline) plus intravesical instillations (sodium hyaluronate) plus pelvic floor muscle training with BFB; BFB-: (n = 75): women with oral drug treatment plus intravesical instillations. age, body mass index (BMI), time of follow-up, length of disease, time free of disease, diseases and health conditions concomitant, and responses to the SF-36 health-related quality of life questionnaire at the first consultation (SF-36 pre-treatment), and at the end of the study (SF-36 post-treatment). The treatment was considered successful when the SF-36 score reached values equal to or greater than 80 points or when the initial value increased by 30 or more points. Mean age was 51.62 years old (23-82). BMI was higher in BFB-. The mean length of BPS/IC condition was 4.92 years (1-20), shorter in BFB+ than in BFB-. Mean SF-36 score pre-treatment was 45.92 points (40-58), lower in BFB+ than in BFB-. Post-treatment SF-36 score was higher than pre-treatment SF-36 score both in BFB+ and BFB-. SF-36 values were higher in BFB+ compared to BFB- over the follow-up. BFB improves quality of life in women with BPS/IC as adjunct therapy to combined oral and intravesical treatment.

SUBMITTER: Borrego-Jimenez PS

PROVIDER: S-EPMC7922867 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Improvement in Quality of Life with Pelvic Floor Muscle Training and Biofeedback in Patients with Painful Bladder Syndrome/Interstitial Cystitis.

Borrego-Jimenez Pedro-Santiago PS Flores-Fraile Javier J Padilla-Fernández Bárbara-Yolanda BY Valverde-Martinez Sebastián S Gómez-Prieto Agustín A Márquez-Sánchez Magaly Teresa MT Mirón-Canelo José-Antonio JA Lorenzo-Gómez María-Fernanda MF

Journal of clinical medicine 20210219 4

<h4>Objective</h4>To prove the benefits of pelvic floor muscle training with biofeedback (BFB) as a complementary treatment in women with bladder pain syndrome/interstitial cystitis (BPS/IC).<h4>Methods</h4>Prospective, randomized study in 123 women with BPS/IC. Groups: BFB+ (n = 48): women with oral drug treatment (perphenazine and amitriptyline) plus intravesical instillations (sodium hyaluronate) plus pelvic floor muscle training with BFB; BFB-: (n = 75): women with oral drug treatment plus i ...[more]

PMID: 33669734

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Project description:ImportanceSupervised pelvic floor muscle training (PFMT) has been recommended as the first-line treatment for women with stress urinary incontinence (SUI), but more evidence on whether adjunctive methods would provide additional benefits is needed.ObjectiveTo compare the efficacy of PFMT with or without a home-based pressure-mediated biofeedback (BF) device.Design, setting, and participantsThis multicenter assessor-blinded randomized clinical trial was conducted in the obstetric clinics of 5 participating tertiary hospitals in China. Participants included eligible women with new-onset postpartum SUI who were enrolled from March 28, 2022, to October 13, 2023.InterventionAll participants received 3 months of supervised PFMT and were randomized to either the intervention (PFMT with a home-based pressure-mediated BF device) or the control group (home-based PFMT).Main outcome and measuresThe primary outcome was the severity of urinary incontinence evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form after 3 months of supervised PFMT. The secondary outcomes included the cure and improvement rates, PFM strength, quality of life, self-efficacy, and adherence.ResultsA total of 452 participants (median age, 34 [IQR, 31-36] years; median body mass index [calculated as the weight in kilograms divided by the height in square meters], 23.71 [IQR, 21.37-25.97]; median time since delivery, 50 [IQR, 43-61] days) were included in the analysis, with 223 in the intervention group and 229 in the control group. Compared with the control group, the intervention group achieved a significantly greater reduction in incontinence severity (median, 3.00 [IQR, 1.00-6.00] vs 2.00 [IQR, 0-4.00] points; z = -3.05; P = .002), significantly increased cure rate (45 of 223 [20.2%] vs 20 of 229 [8.7%]; z = 12.02; P = .001) and improvement (132 of 223 [59.2%] vs 102 of 229 [44.5%]; z = 9.71; P = .002), significantly greater pelvic floor muscle strength (median, 26.00 [IQR, 17.00-38.00] vs 21.00 [IQR, 13.50-33.50] cm H2O; z = -2.28; P = .02), and a significantly greater correlation between subjective and objective adherence (r = 0.825 vs r = 0.627).Conclusion and relevanceIn this randomized clinical trial, the efficacy of pressure-mediated BF combined with PFMT was superior to that of PFMT alone. These findings support the use of pressure-mediated BF devices for improving treatment outcomes for patients with SUI.Trial registrationClinicalTrials.gov Identifier: NCT05115864.

Project description:IntroductionInterstitial Cystitis (IC) is a chronic condition diagnosed based on the presence of symptoms, such as suprapubic/ pelvic pain, pressure or discomfort in association with urgency and increased urinary frequency. Confusable diseases must be excluded. However, there is no objective test or marker to establish the presence of the disease. Diagnosis and patient management is often difficult, given the poor understanding of IC pathogenesis and its unknown etiology and genetics. As an attempt to find biomarkers related to IC, we assessed the association between 20 selected single nucleotide polymorphism (SNPs) with IC and pain severity.ObjectivesTo assess the presence of SNPs in IC patients' blood samples and correlate them with the disease and chronic pain condition.MethodsA case-control study was conducted. We selected 34 female patients with IC diagnosed according to NIDDK criteria and 23 patients in the control group (previously healthy women with only stress urinary incontinence). IC patients were allocated into two groups according to reported chronic pain severity. We selected the following SNPs for analysis: rs1800871, rs1800872, rs1800896, rs1800471, rs1800629, rs361525, rs1800497, rs6311, rs6277, rs6276, rs6313, rs2835859, rs11127292, rs2243248, rs6887695, rs3212227, rs1799971, rs12579350, rs3813034, and rs6746030. Genotyping was performed by real-time PCR (q-PCR).ResultsThe polymorphic allele of SNP rs11127292 exhibited a higher frequency in subjects with IC than in controls (p:0.01). The polymorphic allele of SNP rs6311 was more frequent in patients with severe pain (p:0.03). The frequency of the wild-type allele of SNP rs1799971 was higher in patients with mild to moderate pain (p:0.04).ConclusionThe results indicated differences in SNP frequency among subjects, suggesting that SNPs could serve either as a marker of IC or as a marker of pain severity in IC patients. The study showed promising results regarding IC and polymorphism associations. These associations have not been previously reported.

Project description:ObjectiveTo assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.DesignParallel group randomised controlled trial.Setting23 community and secondary care centres providing continence care in Scotland and England.Participants600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.InterventionsParticipants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.Main outcome measuresThe primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.ResultsMean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.ConclusionsAt 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.Trial registrationISRCTN57756448.

Dataset Information

Improvement in Quality of Life with Pelvic Floor Muscle Training and Biofeedback in Patients with Painful Bladder Syndrome/Interstitial Cystitis.

Publications

Improvement in Quality of Life with Pelvic Floor Muscle Training and Biofeedback in Patients with Painful Bladder Syndrome/Interstitial Cystitis.

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