03218nas a2200217   4500000000100000008004100001100001600042700002000058700001700078700001500095700001600110700001800126700001300144700001800157700001800175245022300193300000800416490000700424520255500431022001402986       2017                            d1 aWang Hai-Bo1 aReilly Kathleen1 aWu Yang-feng1 aSun Xiu-Li1 aWang Zhi-Qi1 aCao Ting-Ting1 aYang Xin1 aHan Jing-Song1 aWang Jian-Liu00aEffect of transcutaneous electrical stimulation treatment on lower urinary tract symptoms after class III radical hysterectomy in cervical cancer patients: study protocol for a multicentre, randomized controlled trial.  a4160 v173 a<p>
<b>BACKGROUND: </b>Class III radical hysterectomy (RH III)_plus pelvic lymphadenectomy is the standard surgery for early stage cervical cancer (CC) patients, the 5&nbsp;year survival rate is about 90%, but pelvic floor disorders especially bladder dysfunction are common due to damaged vessels and nerve fibers following surgery. Transcutaneous electrical stimulation (TENS) treatment has been used to treat bladder disorders for many years, but its effect on cervical cancer patients, the best treatment time point and stimulated protocol, had never been assessed. The aim of this study is to investigate the efficacy of TENS treatment on lower urinary tract symptoms (LUTS) after RH III in CC patients.
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<b>METHODS/DESIGN: </b>The study will be conducted as a clinical, multicentre, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 208 participants (at 1:1 ratio, 104 subjects in each group). At 5-7&nbsp;days after RH III, patients are screened according to operative and pathological findings. Enrolled participants are randomised into an intervention group (TENS plus conventional clinical care) or control group (conventional clinical care), with stratification by menopausal status (menopause vs. non-menopause) and surgical modality (laparoscopic RH or abdominal RH). Participants in both groups will be followed up at 14&nbsp;days, 21&nbsp;days, 28&nbsp;days, 3&nbsp;months, 6&nbsp;months, 12&nbsp;months, 18&nbsp;months and 24&nbsp;months after surgery. The primary endpoint is improvement rate of urination function which is defined as recovery (residual urine ≤50&nbsp;ml) or improvement (residual urine 50-100&nbsp;ml). Secondary endpoints include urodynamic parameter, urinary incontinence, anorectal function, pelvic function, quality of life (QOL), disease-free survival and adverse events. Primary endpoint analyses will be carried out by Cochran-Mantel-Haenszel tests taking into center effect.
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<b>DISCUSSION: </b>To our knowledge this is the first trial to investigate the effect of TENS treatment on bladder function recovery after RH III among CC patients. This study will provide new information on TENS efficacy for bladder function recovery. Once confirmed, it may help to provide a new, non-invisive treatment for those postoperative CC patients with poor pelvic function, which would help improve their quality of life.
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<b>TRIAL REGISTRATION: </b>The study is registered to Clinical Trials.gov ( NCT02492542 ) on June 25, 2015.
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  a1471-2407