A continence promotion intervention involving a pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract, lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with or without androgen deprivation therapy (ADT): A Pilot Study
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ABSTRACT: Interventions: A specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with 6 months no-adjuvant androgen deprivation therapy and men NOT receiving (ADT) prior to beginning radiation therapy. Androgen Deprivation Therapy dose will be standardiesd to Lucrin ( leuprorelin) 22.5 mgs intramuscularly 3 monthly.
The intervention will be delivered one on one with physiotherapist. The protocol will be tailored to men’s measured pelvic floor muscle function and adherence to the program will be encouraged using motivational interviewing principles. Men receiving radiation therapy alone will meet with physiotherapist for review at all follow-up points which are : immediately radiation therapy completed ,at 1 and 3 months after radiation therapy . Ongoing contact with the physiotherapist will be undertaken using men’s preferred method-text/phone/email. All men in the intervention group will receive a copy of the DVD - pelvic floor exercises for men that was produced by the chief investigator for the Prostate Cancer Foundation of Australia. Men receiving ADT will need to exercise for 6 months prior to their RT . These men will also have adherence encouraged as above.
Exercises will be tailored to baseline so men on ADT will need to visit the physiotherapist fortnightly for reassessment and progression. Exercise will need to be performed 3 times daily but the number of repetition each time exercise is undertaken will be tailored to individually to suit the baseline function of men’s measured pelvic floor muscle function. The exercise sets will be the number of contractions that can be repeate
Primary outcome(s): Lower urinary tract symptoms : incontinence, urgency, frequency, nocturia etcetera validated instrument
ICSMLUTS SF
Lower bowel symptoms evaluated using validated instrument
ICSMLUTS Bowel[Baseline for all men:
Immediately following radiation therapy
3 months following radiation therapy
6 months following radiation therapy
Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy
usually 6 months after beginning androgen deprivation therapy.
Thereafter for all men:
Immediately following radiation therapy
3 months after Radiation therapy
6 months after Radiation therapy];Erectile dysfunction using a validated instrument
IIEFQuality of Life validated instrument MYMOP2[Baseline for all men
Men receiving androgen deprivation therapy will be measured again when they attend for their CT simulation session immediately prior to beginning radiation therapy
usually 6 months after beginning androgen deprivation therapy.]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy
DISEASE(S): Lower Bowel Dysfunction As Sequelae To Radiation Therapy With Or Without Androgen Deprivation Therapy,Lower Urinary Tract Sequelae To Radiation Therapy With Or Without Androgen Deprivation Therapy,Erectile Dysfunction As Sequelae To Radiation Therapy With Or Without Androgen Deprivation Therapy,Prostate Cancer Treatment,Renal And Urogenital-other Renal And Urogenital Disorders,Cancer-prostate,Physical Medicine / Rehabilitation-physiotherapy
PROVIDER: 2458234 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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