Hypothesis / aims of study
The primary aim of the present study was to evaluate the effect of pelvic floor muscle training (PFMT) on overactive bladder (OAB) symptoms in women. The secondary aims were to assess pelvic floor muscle function, satisfaction with treatment, side effects and adherence to treatment.
Study design, materials and methods
This is a systematic review conducted from January 11th to January 29th 2018. The primary outcome was OAB symptoms (urgency urinary incontinence, urgency, frequency and nocturia). An electronic search was conducted on MEDLINE/PubMed, Embase, CINAHL, SciELO, SCOPUS, Web of Science and PEDro databases. A secondary search was conducted manually using the references of the selected articles. Only full text articles of randomized controlled trials including female participants were included. Studies investigating PFMT versus inactive control or usual care, other life style modifications or other interventions were included. Studies on pregnant women or women with neurological diseases were excluded. The selection of studies were done by two independent researchers. The risk of bias of included studies was assessed using the Physiotherapy Evidence Database (PEDro) scale. A standardized data extraction form was used to collect data.
Results
A total of 5.083 studies were identified. After exclusions were applied, a total of 8 studies were included. Due to trial heterogeneity and lack of standardized outcome measures, a qualitative analysis was undertaken. There was 100 % agreement between the two reviewers regarding inclusion of the trials. The included articles were published between 2003 and 2017. A total of 675 women were evaluated immediately after the intervention, 199 women were followed for 1-year and 120 for 4 years. Age of participating women ranged from 35 to 80 years. The samples were comprised of a miscellaneous population of women with and without PF dysfunction. Five of the RCTs scored 6 and two studies scored 4 or 5 out of 10 on PEDro rating scale. One study was not scored as it was a 4 year follow-up of another included RCT (1,2). The OAB symptoms were assessed by 5 different tools across the studies, including the International Consultation on Incontinence Questionnaires (ICIQ-OAB, ICIQ-UISF) (n=1), non-validated questionnaires (n=3) and the Kings Health questionnaire (n=1).Three studies used only a bladder diary to assess symptoms, and two studies used the bladder diary in addition to a questionnaire. PFMT alone or combined with other interventions was compared to a fitness program (n=1), drug treatment (DT) (n=2), electrical nerve stimulation (n=2), bladder training (BT) (n=2), heat and steam generation (HSGS) (n=1), general education (n=2), and/or control (n=1).The duration of the PFMT interventions ranged from 8 to 12 weeks, and the number of contractions varied from 20-40 contractions sustained for 6-12 seconds, to 30-40 fast contractions. In relation to symptoms of OAB, all studies were homogeneous at baseline. PFMT provided a significant reduction of OAB symptoms in four of the eight included studies. There was a reduction in urinary frequency (n=2), nocturia (n=1), urgency (n=1) and urgency urinary incontinence (UUI) (n=4). Table 1 shows the results of the four included studies that found statistical significant differences between PFMT and comparison groups in relation to OAB symptoms .
Only three studies assessed PFM function, and they used three different assessment tools. Two studies found an improvement in PFM function in the groups receiving PFMT compared to other groups. One study evaluating the additional effect of PFMT to a fitness program found a statistical significant difference between groups in digital palpation (CG: 2.25 (±1.05)/ 2.58 (±0.99); PFMT: 2.17 (±0.98)/ 3.16 (±1.09) p=0.001) and sEMG after 6 weeks of intervention (CG: 25.38 (±13.76)/ 27.80 (±13.96); PFMT: 15.44 (±8.22)/ 28.12 (±16.80) p=0.003). Another study found a statistical significant difference in vaginal manometry between PFMT and ES 12 weeks after cessation of the intervention (PFMT:36.03 ± 21.79; ES: 8.91 ±12.83, P=0.001).
A study comparing PFMT to a control group found no statistical significant difference in peak vaginal manometry (PFMT: 39.7± 20; CG: 19.9± 7.5 p=0.054). Adherence to PFMT was assessed only in three studies. One study showed the median adherence to treatment was superior in the PFMT group compared to ES. Another study showed significantly higher adherence to physical therapy treatment (BT: 85 %, PFMT: 90 %, and CPFR: 95 %) compared to DT (64 %) (p=0.01). Only one study reported side effects, but they were related to DT. Only two studies reported participant’s satisfaction with the offered treatment. The satisfaction was greater in a Fitness program associated with PFMT compared to the same fitness program without PFMT.
Interpretation of results
This systematic review revealed a miscellaneous of PFMT protocols, comparing groups, outcome measures and follow-up period. Four of 8 studies showed a reduction in OAB symptoms in the groups receiving PFMT. This reduction was not observed in two follow-up studies one and four years after intervention. Although most of the RCTs had a moderate methodological quality according to PEDRO scale, the data could not be combined and the effect size could not be clearly estimated due to heterogeneity of the outcome measures and reporting bias (lack of detailed description of the PFMT protocols, lack of appropriate presentation of statistical results and confidence intervals). Only three of the studies investigated the effect of the interventions on PFM function and two found an improvement in the groups receiving PFMT.