pelvic floor

Pelvic Floor Workout For Preventing Stress Unrinary Incontinence in Primiparous Women A Randomized Clinical Trial

Author/s: 
Lei Gao, Hongmei Zhu, Xiaohui Sun, Shiyan Wang, Bing Xie, Huixin Liu, Wenhui Ren, Jinyu Liang, Xiaoke Tang, Min Zhen, Guizhu Wu, Baoling Qin, Yan Hu, Lingrui Kong, Weipeng Chen, Xiuli Sun, Jianliu Wang

mportance Rehabilitation training methods for stress urinary incontinence (SUI) need to be based on a global postural exercise, involving overall core muscle strength, core stability, and balance of the pelvis and spine. The pelvic floor workout (PEFLOW) program was developed to promote in-pregnancy pelvic floor muscle training to prevent postpartum SUI.

Objective To assess the effectiveness of PEFLOW in preventing postpartum SUI.

Design, Setting, and Participants This multicenter randomized clinical trial was conducted across 9 hospitals in China. Eligibility criteria were primiparous women aged 20 to 40 years, with singleton pregnancy of less than 16 weeks’ gestation, and who visited the outpatient obstetric department of 1 of the 9 hospitals from August 1, 2020, to June 6, 2022. Participants, who were followed up through January 17, 2024, were randomly assigned to the exercise group or the control group and were followed up at 37 weeks’ gestation and 6 weeks, 3 months, 6 months, and 12 months post partum. Primiparous women with severe complications; SUI or pelvic organ prolapse; and/or a history of cervical insufficiency, recurrent miscarriage, or induced labor were excluded. Intention-to-treat (ITT) analysis was conducted between May 1 and July 1, 2024.

Intervention Participants in the exercise group were trained to practice PEFLOW from 28 weeks’ gestation to delivery, with checkups and guidance provided every 2 weeks. Participants in the control group were provided usual medical care.

Main Outcome and Measure The primary outcome was the incidence of SUI at 6 weeks post partum among participants in the exercise and control groups. SUI was diagnosed based on urinary leakage when abdominal pressure increased or detected from a stress test. Symptomatic SUI and the Modified Oxford Scale (MOS) score were recorded.

Results A total of 764 women (median [IQR] age, 29 [27-32] years) were randomized into the exercise group (n = 382) and the control group (n = 382). ITT analysis showed that the incidence of SUI at 6 weeks post partum was significantly lower in the exercise group than the control group (8.7% [32 of 367] vs 13.9% [50 of 360]), with a risk difference of 5.17 (95% CI, 0.36-10.03) percentage points (P = .03). The proportion of women with an MOS score of 4 or higher at 6 weeks post partum was significantly higher in the exercise group than the control group (17.8% [68 of 382] vs 7.9% [30 of 382]), with a risk difference of 9.95 (95% CI, 5.05-14.87) percentage points (P < .001).

Conclusions and Relevance In this multicenter randomized clinical trial, PEFLOW effectively reduced SUI incidence at 6 weeks post partum. This finding suggests that PEFLOW is effective in preventing SUI in pregnancy.

Trial Registration Chinese Clinical Trial Registry Identifier: ChiCTR2000029618

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women

Author/s: 
Dumoulin, Chantale E., Hay-Smith, Jean C., Mac Habee-Seguin, Gabrielle

Background

Pelvic floor muscle training (PFMT) is the most commonly used physical therapy treatment for women with stress urinary incontinence (SUI). It is sometimes also recommended for mixed urinary incontinence (MUI) and, less commonly, urgency urinary incontinence (UUI).

This is an update of a Cochrane Review first published in 2001 and last updated in 2014.

Objectives

To assess the effects of PFMT for women with urinary incontinence (UI) in comparison to no treatment, placebo or sham treatments, or other inactive control treatments; and summarise the findings of relevant economic evaluations.

Search methods

We searched the Cochrane Incontinence Specialised Register (searched 12 February 2018), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings, and the reference lists of relevant articles.

Selection criteria

Randomised or quasi‐randomised controlled trials in women with SUI, UUI or MUI (based on symptoms, signs or urodynamics). One arm of the trial included PFMT. Another arm was a no treatment, placebo, sham or other inactive control treatment arm.

Data collection and analysis

At least two review authors independently assessed trials for eligibility and risk of bias. We extracted and cross‐checked data. A third review author resolved disagreements. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions. We subgrouped trials by diagnosis of UI. We undertook formal meta‐analysis when appropriate.

Main results

The review included 31 trials (10 of which were new for this update) involving 1817 women from 14 countries. Overall, trials were of small‐to‐moderate size, with follow‐ups generally less than 12 months and many were at moderate risk of bias. There was considerable variation in the intervention's content and duration, study populations and outcome measures. There was only one study of women with MUI and only one study with UUI alone, with no data on cure, cure or improvement, or number of episodes of UI for these subgroups.

Symptomatic cure of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were eight times more likely to report cure (56% versus 6%; risk ratio (RR) 8.38, 95% confidence interval (CI) 3.68 to 19.07; 4 trials, 165 women; high‐quality evidence). For women with any type of UI, PFMT groups were five times more likely to report cure (35% versus 6%; RR 5.34, 95% CI 2.78 to 10.26; 3 trials, 290 women; moderate‐quality evidence).

Symptomatic cure or improvement of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were six times more likely to report cure or improvement (74% versus 11%; RR 6.33, 95% CI 3.88 to 10.33; 3 trials, 242 women; moderate‐quality evidence). For women with any type of UI, PFMT groups were two times more likely to report cure or improvement than women in the control groups (67% versus 29%; RR 2.39, 95% CI 1.64 to 3.47; 2 trials, 166 women; moderate‐quality evidence).

UI‐specific symptoms and quality of life (QoL) at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT group were more likely to report significant improvement in UI symptoms (7 trials, 376 women; moderate‐quality evidence), and to report significant improvement in UI QoL (6 trials, 348 women; low‐quality evidence). For any type of UI, women in the PFMT group were more likely to report significant improvement in UI symptoms (1 trial, 121 women; moderate‐quality evidence) and to report significant improvement in UI QoL (4 trials, 258 women; moderate‐quality evidence). Finally, for women with mixed UI treated with PFMT, there was one small trial (12 women) reporting better QoL.

Leakage episodes in 24 hours at the end of treatment: PFMT reduced leakage episodes by one in women with SUI (mean difference (MD) 1.23 lower, 95% CI 1.78 lower to 0.68 lower; 7 trials, 432 women; moderate‐quality evidence) and in women with all types of UI (MD 1.00 lower, 95% CI 1.37 lower to 0.64 lower; 4 trials, 349 women; moderate‐quality evidence).

Leakage on short clinic‐based pad tests at the end of treatment: women with SUI in the PFMT groups lost significantly less urine in short (up to one hour) pad tests. The comparison showed considerable heterogeneity but the findings still favoured PFMT when using a random‐effects model (MD 9.71 g lower, 95% CI 18.92 lower to 0.50 lower; 4 trials, 185 women; moderate‐quality evidence). For women with all types of UI, PFMT groups also reported less urine loss on short pad tests than controls (MD 3.72 g lower, 95% CI 5.46 lower to 1.98 lower; 2 trials, 146 women; moderate‐quality evidence).

Women in the PFMT group were also more satisfied with treatment and their sexual outcomes were better. Adverse events were rare and, in the two trials that did report any, they were minor. The findings of the review were largely supported by the 'Summary of findings' tables, but most of the evidence was downgraded to moderate on methodological grounds. The exception was 'participant‐perceived cure' in women with SUI, which was rated as high quality.

Authors' conclusions

Based on the data available, we can be confident that PFMT can cure or improve symptoms of SUI and all other types of UI. It may reduce the number of leakage episodes, the quantity of leakage on the short pad tests in the clinic and symptoms on UI‐specific symptom questionnaires. The authors of the one economic evaluation identified for the Brief Economic Commentary reported that the cost‐effectiveness of PFMT looks promising. The findings of the review suggest that PFMT could be included in first‐line conservative management programmes for women with UI. The long‐term effectiveness and cost‐effectiveness of PFMT needs to be further researched.

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