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Randomized Controlled Trial
. 2016 Feb;34(1):7-13.
doi: 10.1136/acupmed-2015-010828. Epub 2015 Sep 11.

A pilot study on the use of acupuncture or pelvic floor muscle training for mixed urinary incontinence

Mona Solberg  1 , Terje Alræk  2 , Ibrahimu Mdala  3 , Atle Klovning  3
Affiliations
Randomized Controlled Trial

A pilot study on the use of acupuncture or pelvic floor muscle training for mixed urinary incontinence

Mona Solberg et al. Acupunct Med. 2016 Feb.

Abstract

Objectives: To determine the feasibility and acceptability of traditional Chinese medicine (TCM) acupuncture and pelvic floor muscle training (PFMT) in reducing symptoms and bothersomeness in women with mixed urinary incontinence (MUI); and to estimate the sample size for a full scale trial.

Methods: Thirty-four women with MUI were randomly assigned to either 12 sessions of TCM acupuncture, 12 sessions of PFMT, or to a waiting list control group. Outcome measures included an assessment of interest to participate in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with treatment. Clinical outcomes were assessed at baseline and 12 weeks, and included the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI SF), expectations of treatment effect, and adverse events.

Results: Recruitment was feasible and randomisation worked adequately by means of SurveyMonkey. SurveyMonkey does not permit stratification by ICIQ-UI SF baseline score. Fourteen of 22 women found the treatment options acceptable. The dropout rate was high, especially in the control group (6/12). Outcome forms were completed by 20 of 34 women. The median (IQR) changes of the ICIQ-UI SF scores in the acupuncture, physiotherapy, and waiting list group were 5.5 (2.3 to 6.8), 1.0 (-3.0 to 4.5), and 1.5 (-1.5 to 3.0), respectively, suggesting the need for a full scale trial.

Conclusions: Women with MUI were willing to participate in this study. There is a need for adjusting eligibility criteria. A sample size of 129 women, 43 in three arms, is required. No major adverse events occurred.

Keywords: ACUPUNCTURE; PHYSIOTHERAPY; UROLOGY.

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Figures

Figure 1
Figure 1
Flowchart of the study.
Figure 2
Figure 2
Boxplot showing International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI SF) change score in the three groups.
Figure 3
Figure 3
Regression on expectations and changes in International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI SF).
See this image and copyright information in PMC

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