Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post-prostatectomy Urinary Incontinence
NCT01338584 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2014-11-04
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Pelvic floor muscle training 3 weeks before radical prostatectomy
Participants in the intervention group need to attend the nurse-led clinic 6 times for practising pelvic floor muscle preoperatively instead of starting the exercise one day before surgery (usual management).
- BEHAVIORAL
-
Intensive preoperative pelvic floor muscle training
Patient started to learn pelvic floor muscle 3 weeks before surgery
Sponsors & Collaborators
-
The University of Hong Kong
collaborator OTHER -
Queen Mary Hospital, Hong Kong
lead OTHER
Principal Investigators
-
Sau-loi NG · The University of Hong Kong & Queen Mary Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2015-09-30
- Completion
- 2015-10-31
Countries
- Hong Kong
Study Locations
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