Urinary IncontinenceNCT01338584
Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post-prostatectomy Urinary Incontinence
A study testing Pelvic floor muscle training 3 weeks before radical prostatectomy and Intensive preoperative pelvic floor muscle training in people with Urinary Incontinence, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training 3 weeks before radical prostatectomy and Intensive preoperative pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chinese;
- Physically able to complete the pad test
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
NG Sau-loi
Hong Kong, Heng Fa Chuen
Sau-loi NG, DN (student), (852) 91907149, sauloi_ng@yahoo.com.hk
Sau-loi NG, DN(student)
About this study
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.
Read the 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).
- Conditions
- Urinary Incontinence
- Being tested
- Pelvic floor muscle training 3 weeks before radical prostatectomy, Intensive preoperative pelvic floor muscle training
- Keywords
- Pelvic floor muscle training, Post prostatectomy, Early regaining of urinary continence, Positive improvement in quality of life
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training 3 weeks before radical prostatectomyBehavioural
Also called Pelvic floor muscle training
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).
Intensive preoperative pelvic floor muscle trainingBehavioural
Also called post prostatectomy, promote urinary continence
Patient started to learn pelvic floor muscle 3 weeks before surgery
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training, post prostatectomy | Experimental | Pelvic floor muscle training will be taught on the day of admission Receives: Behavioral: Pelvic floor muscle training 3 weeks before radical prostatectomy; Behavioral: Intensive preoperative pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grams of urine loss at different intervals post surgery
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.
Measured: 4, 8, 12, and 24 weeks post surgery
Secondary outcomes (1)
Change in patients' sense of self control in urination and quality of life at different intervals post surgery
- 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.
- 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)
Measured: 4, 8, 12, and 24 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Sau-loi NG, Queen Mary Hospital, Hong Kong
- Investigators
- Sau-loi NG, Principal investigator, The University of Hong Kong & Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338584
- Sponsor's protocol ID
- UW 11-046
- Status last verified
- Nov 2014
- First submitted
- 4 Apr 2011
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hunter KF, Moore KN, Glazener CM. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2007 Nov;100(5):1191; author reply 1191-2. doi: 10.1111/j.1464-410X.2007.07248_1.x. No abstract available.
PubMed 17922792Novara G. Editorial comment on: does physiotherapist-guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy? A randomised clinical trial. Eur Urol. 2008 Aug;54(2):447. doi: 10.1016/j.eururo.2008.04.023. Epub 2008 Apr 18. No abstract available.
PubMed 18448232
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Study of the Efficacy of Intensive Preoperative Pelvic Floor Muscle Training to Decrease Post-prostatectomy Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01338584
- Acronym / sponsor ID
- UW 11-046
- Conditions
- Urinary Incontinence
- Keywords
- Pelvic floor muscle training, Post prostatectomy, Early regaining of urinary continence, Positive improvement in quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- Feb 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training, post prostatectomy | Experimental | Behavioral: Pelvic floor muscle training 3 weeks before radical prostatectomy, Behavioral: Intensive preoperative pelvic floor muscle trainingPelvic floor muscle training will be taught on the day of admission |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Chinese;
- Physically able to complete the pad test
Key exclusion criteria (6 listed)
- Prior bladder surgery;
- Prior urinary incontinence;
- Neurogenic dysfunction of the lower urinary tract;
- Pre-operative history of overactive bladder;
- Impaired mental status;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training 3 weeks before radical prostatectomyAlso: Pelvic floor muscle trainingParticipants 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). | Behavioural | Pelvic floor muscle training, post prostatectomy |
| Intensive preoperative pelvic floor muscle trainingAlso: post prostatectomy, promote urinary continencePatient started to learn pelvic floor muscle 3 weeks before surgery | Behavioural | Pelvic floor muscle training, post prostatectomy |
Primary outcome
Change in grams of urine loss at different intervals post surgery
Time frame: 4, 8, 12, and 24 weeks post surgery
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Background: PubMed 17922792Hunter KF, Moore KN, Glazener CM. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2007 Nov;100(5):1191; author reply 1191-2. doi: 10.1111/j.1464-410X.2007.07248_1.x. No abstract available.
- Background: PubMed 18448232Novara G. Editorial comment on: does physiotherapist-guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy? A randomised clinical trial. Eur Urol. 2008 Aug;54(2):447. doi: 10.1016/j.eururo.2008.04.023. Epub 2008 Apr 18. No abstract available.
- The University of Hong KongLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sau-loi NG principal investigator
The University of Hong Kong & Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training 3 weeks before radical prostatectomy and Intensive preoperative pelvic floor muscle training in people with Urinary Incontinence, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sau-loi NG ((852) 91907149, sauloi_ng@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grams of urine loss at different intervals post surgery (time frame: 4, 8, 12, and 24 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338584, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.