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

NCT01338584 | Unknown

• 1 other identifier: UW 11-046
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Urinary Incontinence

Keywords

Pelvic floor muscle training; Post prostatectomy; Early regaining of urinary continence; Positive improvement in quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  4, 8, 12, and 24 weeks post surgery

Study Arms (1)

Pelvic floor muscle training, post prostatectomy

EXPERIMENTAL

Pelvic floor muscle training will be taught on the day of admission

Behavioral: Pelvic floor muscle training 3 weeks before radical prostatectomy; Behavioral: Intensive preoperative pelvic floor muscle training

Interventions

Pelvic floor muscle training 3 weeks before radical prostatectomy BEHAVIORAL

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).

Also known as: Pelvic floor muscle training

Pelvic floor muscle training, post prostatectomy

Intensive preoperative pelvic floor muscle training BEHAVIORAL

Patient started to learn pelvic floor muscle 3 weeks before surgery

Also known as: post prostatectomy, promote urinary continence

Pelvic floor muscle training, post prostatectomy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese;
• Physically able to complete the pad test

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

NG Sau-loi

Hong Kong, Heng Fa Chuen, Hong Kong

RECRUITING

Related Publications (2)

• 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.

  PMID: 17922792 BACKGROUND

• Novara 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.

  PMID: 18448232 BACKGROUND

Related Links

• The University of Hong Kong

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sau-loi NG

  The University of Hong Kong & Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sau-loi NG

CONTACT

(852) 91907149; sauloi_ng@yahoo.com.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Practice Nurse

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 19, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

HK (1)