Dataset Information

Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol

ABSTRACT:

Background

Vaginal laxity is an underreported condition that negatively affects women’s sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity.

Methods/Design

This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp–REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas–UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention).

Expected results

The results of this randomized clinical trial will have a positive impact on the participants’ quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity.

Trial registration

Registry: RBR-2zdvfp–Registro Brasileiro de Ensaios Clínicos–REBEC (19/02/2020).

SUBMITTER: Pereira G

PROVIDER: S-EPMC8577744 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThere is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. However, there is disagreement about the method and intensity of PFM training and the relevant measurements. To pilot the study in PFM training, we designed a Pelvic Floor Workout (PEFLOW) for women to train their pelvic through entire body exercises, and we planned a trial to evaluate its effectiveness through comparing the outcomes from a group of postpartum women who perform PELFLOW at home under professional guidance online with the control group.Methods/designThe randomized controlled trial was projected to be conducted from November 2021 to March 2023. A total of 260 postpartum women would be recruited from the obstetrics departments of the study hospital and women would be eligible for participation randomized into experimental or control groups (EG/CG) if their PFM strength are scaled by less than Modified Oxford grading Scale (MOS) to be less than grade 3. Women in EG would perform a 12-week PEFLOW online under the supervision and guidance of a physiotherapist, while women in CG would have no interventions. Assessments would be conducted at enrollment, post intervention (for EG) or 18th to 24th week postpartum (for CG), and 1 year postpartum. Assessment would be performed in terms of pelvic floor symptoms, including MOS, cough stress test, urinary leakage symptoms, pelvic organ prolapse quantitation (POP-Q), and vaginal relaxation, clinic examinations including Pelvic floor electrophysiological test, Pelvic floor ultrasound and Spine X-ray, overall body test including trunk endurance test, handgrip test, body composition test, and questionnaires including International Physical Activity Questionnaire Score-Short Form(IPAQ-SF), Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the 6-item Female Sexual Function Index (FSFI-6), and the Pittsburgh Sleep Quality Index (PSQI). Primary analysis will be performed to test our main hypothesis that PEFLOW is effective with respect to strengthen PFM strength.DiscussionThis trial will demonstrate that pelvic floor-care is accessible to most women and clinical practice on PFD may change relevantly should this study find that Online PEFLOW approach is effective to improve PFMs.Trial registrationClinicalTrials.gov, NCT05218239.

Project description:BackgroundPelvic floor dysfunction is a public health issue, with 1 in 3 women experiencing symptoms at some point in their lifetime. The gold standard of treatment for pelvic floor dysfunction is supervised pelvic floor muscle training (PFMT); however, adherence to PFMT in women is poor. Mobile apps are increasingly being used in the National Health Service to enable equity in the distribution of health care and increase accessibility to services. However, it is unclear how PFMT mobile apps influence PFMT adherence in women.ObjectiveWe aimed to identify which behavior change techniques (BCTs) have been used in PFMT mobile apps, to distinguish the core "capability, opportunity, and motivation" (COM) behaviors targeted by the BCTs used in PFMT mobile apps, and to compare the levels of PFMT adherence in women between those using PFMT mobile apps and those receiving usual care.MethodsWe conducted a scoping review of the literature. Published quantitative literature that compared the use of a PFMT mobile app to a control group was included to address the objectives of the study. The electronic bibliographic databases searched included MEDLINE, CINAHL, Scopus, Web of Science, and PEDro, along with CENTRAL. Studies were also identified from reference searching of systematic reviews. Original articles written in English from 2006 onward were included. Nonexperimental quantitative studies, qualitative studies, studies that use male participants, case studies, web-based interventions, and interventions that use vaginal probes were excluded. Narrative synthesis was conducted on eligible articles based on the aims of the study.ResultsOf the 114 records retrieved from the search, a total of 6 articles met the eligibility and inclusion criteria. The total number of participants in the studies was 471. All PFMT mobile apps used the BCT "prompts and cues." Opportunity was the core COM behavior targeted by the PFMT mobile apps. Higher levels of adherence to PFMT were observed among women using PFMT mobile apps.ConclusionsDigital "prompts and cues" are a BCT commonly used in PFMT mobile apps, and further research is required to practically assess whether a future randomized controlled trial that investigates the effectiveness of digital "prompts and cues" on PFMT adherence in women can be conducted.

Project description:Background Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. Methods Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18?month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. Results A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women’s health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff’s role and core work. Conclusion Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women’s health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

Project description:BackgroundPelvic floor muscle training is recommended as first line treatment for urinary incontinence in women based on three proposed theorized mechanisms: 'Enhanced Pelvic Floor Muscle Strength,' 'Maximized Awareness of Timing,' and 'Strengthened Core Muscles'. The purpose of this scoping review was to systematically map evidence for and against theorized mechanisms through which pelvic floor muscle training interventions work to reduce urinary incontinence in women.MethodsThe scoping review is based upon a comprehensive search of relevant literature published from 1990 to 2020 in PubMed, CINAHL, PsycINFO, ClinialTrials.gov, reference lists from review articles, and hand searches of articles by known researchers in the field. We included English-language, peer-reviewed articles on pelvic floor muscle training as an intervention for adult women if they provided empirical evidence to testing the theorized intervention mechanisms. Two independent reviewers screened articles for inclusion and extracted data to describe details of each study (author, year, country, design, sampling), measures of pelvic floor muscle strength and urinary incontinence, statistical analysis of linkage between changes in the measures, and pelvic floor muscle training regimens. Data were summarized to facilitate the integration of diverse evidence to draw conclusions on supporting or refuting the three proposed theorized mechanisms for managing urinary incontinence in women.ResultsOf the 278 articles identified with the search, 13 (4.7%) met inclusion criteria. There was weak to no evidence for the mechanism of enhanced pelvic floor muscle strength, equivocal support for maximized awareness of timing, and no evidence for strengthened core muscles.ConclusionsThis review revealed extremely limited data supporting the proposed theorized mechanisms underlying pelvic floor muscle training programs to manage urinary incontinence in women. Such evidence is needed to help women and clinicians understand how, why and when a woman benefits from pelvic floor muscle training. Future studies should specifically state and report statistical analysis that relates the theorized mechanisms to the training outcomes observed.

Project description:ObjectiveTo compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse.DesignRandomised controlled trial.SettingDutch primary care.ParticipantsWomen aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language.InterventionsPelvic floor muscle training versus watchful waiting.Main outcome measuresThe primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients' perceived change in symptoms.ResultsOf the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups.ConclusionsAlthough pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of overall symptoms. More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.Trial registration Dutch Trial Register (www.trialregister.nl) identifier: NTR2047.

Project description:BackgroundPelvic floor muscle training (PFMT) is one of the first-line treatments for stress urinary incontinence among pregnant women. Mobile health (mHealth) technology is potentially effective for delivering PFMT to pregnant women. Persuasive technology in the development of such mobile apps may facilitate behavior change by improving adherence to the exercises. The Capability, Opportunity, and Motivation-Behavior (COM-B) model is potentially useful in selecting the appropriate interventions to be incorporated into the apps.ObjectiveThis review of mHealth apps for PFMT aims to describe the principles of persuasion used for each app and to propose mHealth app design features based on the COM-B model.MethodsA systematic literature search was conducted to answer three main research questions: what are the available mHealth apps for PFMT in the published literature, what persuasive strategies were used in their studies how were they mapped to the COM-B model, and how effective were the selected persuasive strategies for PFMT adherence? We searched PubMed, CINAHL, Web of Science, Scopus, and local Malaysian databases such as MyCite and MyMedR for articles reporting mHealth apps used for the delivery of PFMT. We included original articles reporting experimental and cross-sectional studies, including pilot or feasibility trials. Systematic and narrative reviews were excluded. Narrative and thematic syntheses were conducted on the eligible articles based on the research questions. The Cochrane risk of bias tool and the Risk of Bias Assessment Tool for Non-randomized Studies were used to assess study bias.ResultsOf the 169 records from the initial search, 10 (5.9%) articles meeting the selection criteria were included in this review. There were 8 mHealth apps designed for the delivery of PFMT. The Tät, which used 3 categories of persuasive system design, improved PFMT adherence and was cost-effective. Only 1 app, the iBall app, used all categories of persuasive system design, by including social support such as "competition" in its design. The Diário Saúde app was the only app developed using operant conditioning. All apps incorporated Tailoring and Expertise as part of their PSD strategies. Only 3 apps, the Diário Saúde, Tät, and Pen Yi Kang demonstrated improved PFMT adherence.ConclusionsPersuasive technology used in mobile apps may target desired behavior change more effectively. The persuasive system design can be mapped to the COM-B model to explain its effectiveness on behaviour change outcomes.

Project description:OBJECTIVE:This subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI). MATERIALS AND METHODS:The VIVEVE I clinical trial was prospective, randomized, single-blind, and Sham-controlled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had ?1 term vaginal delivery and a baseline FSFI total score ?26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90?J/cm2) vs. Sham (?1?J/cm2)] delivered to the vaginal tissue. Independent analyses were conducted for each FSFI domain to evaluate both the mean change, as well as the clinically important change for Active- versus Sham-treated subjects at 6 months post-intervention. RESULTS:Subjects randomized to Active treatment (n?=?73) had greater improvement than Sham subjects (n?=?35) on all FSFI domains of sexual function at 6 months postintervention. The analysis of covariance change from baseline analyses showed statistically significant improvements, in favor of Active treatment, for sexual arousal (p?=?0.004), lubrication (p?=?0.04), and orgasm (p?=?0.007). In addition, Active treatment was associated with clinically important and statistically significant improvements in sexual desire [Odds ratio (OR)?=?3.01 (1.11-8.17)], arousal [OR?=?2.73 (1.06-7.04)], and orgasm [OR?=?2.58 (1.08-6.18)]. CONCLUSIONS:This subanalysis showed CMRF therapy is associated with statistically significant and clinically important improvements in sexual function in women with vaginal laxity. These findings provide the first randomized, placebo-controlled energy-based device evidence for functional improvements associated with a nonsurgical modality for a highly prevalent and undertreated condition.