Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post-prostatectomy Urinary Incontinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Queen Mary Hospital, Hong Kong
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Sau-loi NG, Queen Mary Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01338584
First received: April 4, 2011
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Urinary Incontinence
Behavioral: Pelvic floor muscle training 3 weeks before radical prostatectomy
Behavioral: Intensive preoperative pelvic floor muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post-prostatectomy Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Queen Mary Hospital, Hong Kong:

Primary Outcome Measures:
  • Change in grams of urine loss at different intervals post surgery [ Time Frame: 4, 8, 12, and 24 weeks post surgery ] [ Designated as safety issue: No ]
    To determine the benefit of starting intensive PFMT before radical prostatectomy and continuing PFMT postoperatively in order to promote (1) early regaining of urinary continence in the intervention group by weighted pad after pad test and (2) any positive improvement in quality of life in the intervention group.


Secondary Outcome Measures:
  • Change in patients' sense of self control in urination and quality of life at different intervals post surgery [ Time Frame: 4, 8, 12, and 24 weeks post surgery ] [ Designated as safety issue: No ]
    1. The intervention group will significantly regain bladder control by decreasing urine leakage as measured by pad test than the control group by the end of three months post surgery.
    2. The intervention group will report better quality of life as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), Incontinence Impact on Quality (IIQ-7) and Health-related Quality of Life (SF 12)


Estimated Enrollment: 84
Study Start Date: February 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelvic floor muscle training, post prostatectomy
Pelvic floor muscle training will be taught on the day of admission
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).
Other Name: Pelvic floor muscle training
Behavioral: Intensive preoperative pelvic floor muscle training
Patient started to learn pelvic floor muscle 3 weeks before surgery
Other Names:
  • intensive preoperative pelvic floor muscle training
  • post prostatectomy
  • promote urinary continence

Detailed Description:

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).

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese;
  • Physically able to complete the pad test

Exclusion Criteria:

  • Prior bladder surgery;
  • Prior urinary incontinence;
  • Neurogenic dysfunction of the lower urinary tract;
  • Pre-operative history of overactive bladder;
  • Impaired mental status;
  • Allergic to latex.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338584

Contacts
Contact: Sau-loi NG (852) 91907149 sauloi_ng@yahoo.com.hk

Locations
Hong Kong
NG Sau-loi Recruiting
Hong Kong, Heng Fa Chuen, Hong Kong
Contact: Sau-loi NG, DN (student)    (852) 91907149    sauloi_ng@yahoo.com.hk   
Principal Investigator: Sau-loi NG, DN(student)         
Sponsors and Collaborators
Queen Mary Hospital, Hong Kong
The University of Hong Kong
Investigators
Principal Investigator: Sau-loi NG The University of Hong Kong & Queen Mary Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Sau-loi NG, Advanced Practice Nurse, Queen Mary Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT01338584     History of Changes
Other Study ID Numbers: UW 11-046
Study First Received: April 4, 2011
Last Updated: July 25, 2013
Health Authority: Hong Kong:Institutional Review Board of The University of Hong Kong / Hospital authority Hong Kong West Cluster

Keywords provided by Queen Mary Hospital, Hong Kong:
Pelvic floor muscle training
Post prostatectomy
Early regaining of urinary continence
Positive improvement in quality of life

Additional relevant MeSH terms:
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 29, 2014