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Feasibility trial of pelvic floor rehabilitation for bowel function issues after colorectal cancer surgery.

A pelvic floor rehabilitation program for patients with bowel dysfunction after sphincter- preserving surgery for colorectal cancer: a feasibility study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000821998
Enrollment
15
Registered
2020-08-17
Start date
2021-05-05
Completion date
2024-04-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine the possibility and to examine if a short- term pelvic floor rehabilitation program can improve bowel issues after bowel cancer surgery with or without radiochemotherapy. Who is it for? You may be eligible for this study if you are an adult experiencing bowel issues after surgery for colorectal cancer. Study details Participants in this study will receive: 1. Education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises. 2. A 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strength training with use of an non- invasive technique called transperineal ultrasound for visual biofeedback, and anorectal sensory and coordination retraining using an minimally invasive technique called rectal balloon catheter biofeedback. Participants will also be instructed to practise home exercises and to complete a daily pelvic floor exercise diary. It is hoped that this research will determine the possibility of a short-term pelvic floor rehabilitation program for patients with bowel dysfunction after colorectal cancer surgery and treatment in an outpatient setting as well as identify the signals of benefit of pelvic floor rehabilitation for the improvement of bowel function and quality of life.

Interventions

Name: Pelvic floor rehabilitation program Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting. Intervent

Name: Pelvic floor rehabilitation program Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting. Intervention: A 15 minutes of education session will be provided at the commencement of the program at first week. Participants will be provided education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.The educational information and home exercise pamphlet is specifically designed for this study. Each participant will be assessed on their anorectal physiology by a colorectal surgeon and pelvic floor physiotherapist. Patient reported outcomes on bladder, bowel, sexual function and quality of life will be examined with questionnaires before and after the intervention. The intervention is a 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strengthening with use of transperineal ultrasound for visual biofeedback, anorectal sensory and coordination retraining using rectal balloon catheter biofeedback. Visual feedback will be provided via the application of a transperineal ultrasound. The patient will be able to visualise the pelvic floor muscle activity on the screen during the training session. A rectal balloon catheter will be used to provide sensory feedback in order to train pelvic floor muscle strength, rectal sensation and coordination. Verbal instruction will be given during the supervising session and a home exercise pamphlet explaining the exercises will be given to the patient. The pelvic floor exercises involve the contraction and relaxation of pelvic floor muscle together with diaphragmatic breathing. Pelvic floor exercises: two times per day with one for strength and one for endurance training. Strength training: 70%o of maximal pelvic floor muscle contraction, 10 reps x 3 sets with 1 minute rest in between. Endurance training: 50% of maximal pelvic floor muscle contraction 15 reps x5 sets with 2 minutes rest in between. This pelvic floor rehabilitation program will be delivered by a physiotherapist in the area of pelvic floor disorders with minimum 5 years experience. Participants will also be instructed to practise home exercises and to complete a daily pelvic floor exercise diary. Patients' satisfaction survey and attendance record will be evaluated at the end of the program for intervention adherence. Due to the recent global pandemic outbreaks, a telehealth option will be included in the study procedure to minimise the risk of exposure to coronavirus in both staff and participants. The telehealth consultation may replace face-to-face training sessions at any timepoint during the 10-weeks training. For the 10 weeks pelvic floor rehabilitation, participants will receive 5 mandatory face-to-face training sessions for biofeedback and 5 sessions for progressive pelvic floor exercise training which can be either face to face or via telehealth. Where possible the rehabilitation program will be carried out over 10 consecutive weeks whether it’s face-to-face or telehealth session.

Sponsors

Concord Repatriation General Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Underwent anterior resection with sphincter preservation for colorectal cancer with or without neoadjuvant/adjuvant therapy • Initial onset of bowel dysfunction symptoms after surgery and treatment, with a LARS score >20. • Bowel continuity restored without stoma for at least 6 months • No clinical evidence of recurrence of colorectal cancer or distant metastasis

Exclusion criteria

• Aged <18 • Unable to give informed consent or follow instructions due to cognitive or English language difficulties • Neurological disorders or acute exacerbation of inflammatory bowel disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026