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Trial registered on ANZCTR


Registration number
ACTRN12625000927426p
Ethics application status
Submitted, not yet approved
Date submitted
28/07/2025
Date registered
26/08/2025
Date last updated
26/08/2025
Date data sharing statement initially provided
26/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic Floor Physiotherapy and Recurrence of Diverticulitis: A Randomised Pilot Study
Scientific title
Pelvic Floor Physiotherapy and Recurrence of Diverticulitis: A Randomised Pilot Study
Secondary ID [1] 315011 0
None
Universal Trial Number (UTN)
U1111-1325-9570
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diverticulitis 338345 0
Condition category
Condition code
Oral and Gastrointestinal 334644 334644 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pelvic floor physiotherapy will include individualised assessment of each subject with a tailored treatment program based on the assessment findings. Treatment may include education, lifestyle advice, toileting techniques, pelvic floor training (strength or down-training exercises), electromyography (EMG) or rectal balloon biofeedback, tibial nerve stimulation with a transcutaneous electrical nerve stimulation (TENS) machine, interferential therapy, abdominal massage or other therapies relevant for that subject. The duration of intervention will be tailored based on individualised patient assessment by the pelvic floor physiotherapist. All patients in the PFPT group will have a one-hour initial assessment with further review appointments as required every 3-4 weeks for a maximum of six months. For the remainder of the 12 month follow-up, there are no expected further appointments with PFPT.
Intervention code [1] 331607 0
Prevention
Comparator / control treatment
Those randomised into the standard of care group will proceed with usual clinical care. This includes education on dietary fibre supplementation. No additional study related appointments or interventions will be required.
Control group
Active

Outcomes
Primary outcome [1] 342321 0
Recurrence of diverticulitis
Timepoint [1] 342321 0
12 months from discharge of patient after admission with acute diverticulitis.
Secondary outcome [1] 450313 0
Need for surgical intervention (such as Hartmann's procedure or anterior resection, other appropriate colectomy operations or abdominal wash out) as deemed appropriate by a general surgeon.
Timepoint [1] 450313 0
12 months from discharge of patient after admission with acute diverticulitis.
Secondary outcome [2] 451402 0
Need for radiological intervention (such as percutaneous aspiration or insertion of drain) as deemed appropriate by a general surgeon.
Timepoint [2] 451402 0
12 months from discharge of patient after admission with acute diverticulitis.

Eligibility
Key inclusion criteria
Adult patients admitted to QEII Hospital or Logan Hospital with acute diverticulitis within a 12 month period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring emergency surgery or interventional radiology management on index presentation will be excluded. Patients admitted for elective procedures for diverticular disease will be excluded. Patients who do not consent to inclusion or who withdraw consent during the study period will be excluded. Patients randomised to the PFPT group but who do not attend at least one physiotherapy appointment within 6 months of discharge will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a randomised pilot study to assess viability of implementation of larger study. As a result, this study will recruit up to 40 patients (aiming 20 per group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
31/08/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28246 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [2] 28247 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 44458 0
4108 - Coopers Plains
Recruitment postcode(s) [2] 44459 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 319577 0
Hospital
Name [1] 319577 0
Queen Elizabeth II Jubilee Hospital
Country [1] 319577 0
Australia
Funding source category [2] 319735 0
Hospital
Name [2] 319735 0
Logan Hospital
Country [2] 319735 0
Australia
Primary sponsor type
Hospital
Name
Queen Elizabeth II Jubilee Hospital
Address
Country
Australia
Secondary sponsor category [1] 322071 0
None
Name [1] 322071 0
Address [1] 322071 0
Country [1] 322071 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318138 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 318138 0
Ethics committee country [1] 318138 0
Australia
Date submitted for ethics approval [1] 318138 0
19/07/2025
Approval date [1] 318138 0
Ethics approval number [1] 318138 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143238 0
Dr Imran Aumeerally
Address 143238 0
Queen Elizabeth II Jubilee Hospital, Troughton Rd, Coopers Plains QLD 4108
Country 143238 0
Australia
Phone 143238 0
+61 408186991
Fax 143238 0
Email 143238 0
[email protected]
Contact person for public queries
Name 143239 0
Imran Aumeerally
Address 143239 0
Queen Elizabeth II Jubilee Hospital, Troughton Rd, Coopers Plains QLD 4108
Country 143239 0
Australia
Phone 143239 0
+61 731826111
Fax 143239 0
Email 143239 0
[email protected]
Contact person for scientific queries
Name 143240 0
Imran Aumeerally
Address 143240 0
Queen Elizabeth II Jubilee Hospital, Troughton Rd, Coopers Plains QLD 4108
Country 143240 0
Australia
Phone 143240 0
+61 731826111
Fax 143240 0
Email 143240 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.