Urinary Incontinence Clinical Trial
Official title:
A Randomized Controlled Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post-prostatectomy Urinary Incontinence
Urinary incontinence after radical prostatectomy is a significant clinical problem despite
advances in surgical techniques. In the literature, the incidence of post prostatectomy
urinary incontinence varies widely from 0.5 to 87% (Parekh et al, 2003). Various reasons are
held responsible for this wide discrepancy, including surgical technique, definition of
incontinence, time of evaluation, pathological stage, and patient age. The etiology of post
prostatectomy urinary incontinence has been attributed to sphincteric deficiency, either
from injury of striated muscle fibres or the innervating nerve fibres (Koelbl et al 2002).
The effect of urinary incontinence on the quality of life in these patients has been subject
to debate (Litwin et al, 1995; Braslis et al, 1995). For many patients, however, early
recovery from urinary incontinence has been a major concern (Moore et al, 1999), especially
in younger patients.
Various treatment modalities for post prostatectomy urinary incontinence have been
introduced, including conservative managemnt such as pelvic floor muscle training,
pharmacological treatment and surgical treatment. However, surgery is an invasive procedure
and it's usually be the last resort. Although the Cochrane Incontinence Group (2007)
commented on the need for ongoing research to clarify the role of pelvic floor muscle
training, it is still the first-line treatment used to restore pelvic floor or bladder
function after radical prostatectomy (MacDonald et. al., 2007). Currently, patients learned
pelvic floor muscle training on the day of admission for surgery by ward staff in HA
hospitals of Hong Kong. Subsequently, after removal of urethral catheter, patients will
attend the nurse-led clinic for reassessment and reinforcement of pelvic floor muscle
training. The continence rates which defined as zero pad were 69%, 78.7% and 88.9% at 3
months, 6 months and 12 months respectively (Tam and Ho et al., 2010). In order to determine
the efficacy of intensive preoperative pelvic floor muscle training to decrease
post-prostatectomy urinary incontinence, a randomized controlled trial will be conducted.
Participants in the intervention group would start the pelvic floor muscle training 3 weeks
before surgery provided by an urology nurse specialist whereas the control group would start
the pelvic floor muscle training on the day of admission for surgery provided by ward staff.
Measurement on the grams of urine loss, sense of self control in urination and quality of
life are collected on 4, 8, 12 and 24 weeks after surgery for comparison between the two
groups.
Prostate cancer is one of the most important health problems in men. According to the
information from Centre of Health Promotion (CHP) in January 2010, prostate cancer recorded
the largest increase in incidence rate among the common male cancers in Hong Kong during the
past two decades. In 2007, prostate cancer was the fourth most common cancer in men and
there were 1 205 newly diagnosed cases of prostate cancer. It accounted for 9.2% of all new
cancer cases in males. It is the fifth leading cause of male cancer deaths in Hong Kong. In
2008, a total of 282 men died from this cancer, accounting for 3.8% of male cancer deaths.
For patients with disease confined to the prostate, several treatment alternatives are now
available. However, radical prostatectomy remains the standard for long-term cure
(Guidelines of American Urological Association, 2010). The incidence of incontinence and
erectile dysfunction is higher after operation than other therapies for localized prostate
cancer (Alivizatos, et al, 2005). Based on the literature review, the post prostatectomy
urinary incontinence (PPUI) rates were ranging from 0.5-87% (Parekh, et al, 2003) and
potency rates ranging from 11-87% (Alivizatos, et al, 2005). Various reasons are held
responsible for this wide discrepancy, including surgical technique, definition of
incontinence, time of evaluation, pathological stage, and patient age (Pannek & Konig,
2005). However, the majority of the patients undergoing radical prostatectomy would vote for
the operation again as they put tumour free on their first priority (Alivizatos, et al.,
2005). The cause of urinary incontinence after radical prostatectomy is not completely
understood, but leakage is thought to result primarily from sphincteric insufficiency,
resulting from sphincteric injury or detrusor overactivity and effects on the bladder
detrusor muscle (Leach, 1995). Men afflicted with urinary incontinence must contend with
shame, embarrassment, depression, avoidance of social activities and altered life style
(Braslis et al., 1995; Herr, 1994). So, early and appropriate management of urinary
incontinence can improve one's quality of life and reduce the adverse consequences of
urinary incontinence such as lowering of the physical health causing disability and
dependence, affecting the psychological well-being and social functioning; as well as
escalating health care costs (White & Getliffe, 2003; Wyman, 2003).
Sueppel et al. (2001) found that pelvic floor muscle training (PFMT) taught pre operatively
helped patients achieve continence quicker than if only taught post operatively. There was
significant improvement in the intervention group objectively by weighting the pad in every
visit (pad weight: 2.8 g in intervention group whereas 33.3 g in control group). Previously,
Bales et al. (2000) recruited 100 men scheduled to undergo radical prostatectomy were
randomized to receive PFMT with biofeedback 2-4 weeks before surgery by a nurse pre and post
operatively or to a group only receive briefly verbal instruction on PFMT without
biofeedback. Six months following surgery, the continence rates, as defined by the use of
one pad or less per day were 96% (44 of 47) and 96% (48 of 50) in the biofeedback and
control groups respectively. The authors concluded that pre operative formal PFMT and
biofeedback training did not improve the outcome of PFMT on overall continence as measured
by number of pads used or the rate of return of urinary control in men undergoing radical
prostatectomy at 6 months (p=0.596).
Among all studies reviewed, the efficacy of pre operative PFMT in early regaining of urinary
control after radical prostatectomy is still inconclusive. Thus, further studies on PFMT for
PPUI are needed (Centemero & Rigatti, et al., 2010).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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