Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000134628p
Ethics application status
Submitted, not yet approved
Date submitted
16/01/2023
Date registered
8/02/2023
Date last updated
8/02/2023
Date data sharing statement initially provided
8/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a novel intravaginal device for rehabilitating women with pelvic organ prolapse.
Scientific title
Development of a novel intravaginal device for rehabilitating women with pelvic organ prolapse: Investigating safety and feasibility of use.
Secondary ID [1] 308759 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse 328705 0
Condition category
Condition code
Physical Medicine / Rehabilitation 325716 325716 0 0
Other physical medicine / rehabilitation
Renal and Urogenital 325909 325909 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine the feasibility, safety, and function of intravaginal electrical stimulation (IVES), participants will be asked to use the device in 3-minute stimulation increments over a single 20-30-minute session with the stimulation device. During this session, participants will be administered IVES by a pelvic floor physiotherapist using a physiotherapist recommended protocol with a stimulation device restricted to a frequency range of 2-100Hz, current amplitude of 0-90mA, pulse width between 50µs-450µs, controllable duty cycle, controllable ramp up time, and a biphasic wave output. The precise protocol used will depend on the ability of the impulse to produce a valuable contraction. This will help correlate contraction strength with frequency. During administration of the IVES, the protocol, pelvic floor muscle contraction strength, pain/discomfort, and any adverse events will be recorded.
Intervention code [1] 325214 0
Treatment: Devices
Intervention code [2] 325215 0
Rehabilitation
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333564 0
Strength of pelvic floor muscle contraction determined using the digital palpation scale developed by the International Continence Society (Absent vs Weak vs Normal/moderate vs Strong contraction) and transperineal ultrasound.
Timepoint [1] 333564 0
Assessed continuously during stimulation
Secondary outcome [1] 417533 0
Stimulation frequency determined by accessing device settings
Timepoint [1] 417533 0
Assessed continuously during stimulation
Secondary outcome [2] 417534 0
Pain/discomfort perceived by participants using 11-point visual analog scale
Timepoint [2] 417534 0
Immediately post-stimulation
Secondary outcome [3] 417535 0
Side effects experienced by participants using a study-specific questionnaire. Examples include pain, irritation, discomfort, and bleeding.
Timepoint [3] 417535 0
Immediately post-stimulation
Secondary outcome [4] 417536 0
Patient feedback on device experience and overall acceptability using a study-specific questionnaire
Timepoint [4] 417536 0
Immediately post-stimulation
Secondary outcome [5] 417537 0
Clinician feedback on device experience using a study-specific questionnaire
Timepoint [5] 417537 0
Immediately post-stimulation

Eligibility
Key inclusion criteria
The women in the following group:
1. Women above 18 years of age
2. Women with POP-Q Stage 2 or 3

The clinicians included in this study will be the pelvic floor physiotherapists administering IVES to the patient. As such, the clinicians will not be considered participants for recruitment but their feedback on the application to the patient will be sought to understand usability.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women below 18 years of age
2. Patients with an intellectual impairment
3. Women with an allergy to nickel or stainless steel.
4. People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process
5. People highly dependent on medical care
6. Women with a pre-existing cardiac condition and/or possess a cardiac pacemaker or neuromodulation device
7. Women with an active implantable medical device
8. Women with an active deep vein thrombosis
9. Women who are pregnant or within a period of 3 months post-partum
10. Women with any known or suspected tissue damage (eg. levator avulsion) or malignancy, active infection/disease in the vaginal region, impaired vaginal sensation, recently radiated tissue, or recent history of gynaecological surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
3/07/2023
Actual
Date of last data collection
Anticipated
3/07/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23835 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 39290 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 312982 0
Charities/Societies/Foundations
Name [1] 312982 0
Norman Beischer Medical Research Foundation
Country [1] 312982 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 314668 0
Hospital
Name [1] 314668 0
Monash Health
Address [1] 314668 0
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country [1] 314668 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312247 0
Monash Health HREC
Ethics committee address [1] 312247 0
Research Support Services,
Level 2, i Block,
Monash Medical Centre,
246 Clayton Road,
Clayton, VIC, 3168
Ethics committee country [1] 312247 0
Australia
Date submitted for ethics approval [1] 312247 0
18/01/2023
Approval date [1] 312247 0
Ethics approval number [1] 312247 0

Summary
Brief summary
Pelvic organ prolapse (POP) is a common gynaecological condition which has been observed in up to 50% of women above 50 and has an associated 20% risk of surgery during a woman’s lifetime. Despite impacting the lives of millions of women in our society, there are few options available for preventing or addressing this condition.

Defined as the downward displacement of one or more pelvic organs into the vagina, POP can significantly impact the quality-of-life of women with the condition. It has a number of causes including injury from vaginal birth/pregnancy, and is exacerbated by ageing, obesity, genetics, constipation, chronic coughing, heavy lifting, and smoking. Severity is graded using the Pelvic Organ Prolapse Quantification (POP-Q) tool which classifies the degree of descent using the hymen as a reference point. Stages of descent vary from minor descent (Stage 1) to the complete external presentation of the organ (uterus, bladder, bowel) through the vagina (Stage 4).

Symptoms include a heavy sensation or dragging feeling in the vagina, a lump in the vagina, a lump which bulges out and can be felt or seen when standing, painful intercourse or loss of sensation, difficulty emptying the bowel or bladder, recurring urinary tract infections, and faecal or urinary incontinence (UI). According to a report by the Australian Institute of Health and Welfare, UI alone accounts for >$200 million each year in healthcare expenditure in Australia, with drastically more women being affected than men for this condition.

Current clinical protocols primarily have a passive management focus, which includes lifestyle changes or simple intravaginal pessaries, both of which require long-term (often until surgery or end-of-life) investment and adherence by patients; or a rehabilitation focus where pelvic floor muscle training attempts to strengthen the pelvic floor muscles. On the spectrum of invasive practices, 10-20% of women will undergo surgical intervention. However, surgery carries a number of risks, contraindications, and has the disadvantage that up to a third of women may have a recurrence. Additionally, vaginal mesh procedures introduced to reduce the risk of recurrence caused unacceptable adverse events and are no longer approved. Due to these limitations with current management protocols, there is a demand for novel non-surgical treatments which can improve or cure the condition.

IVES could play a role in rehabilitating the pelvic floor muscles of women with POP. It does this by triggering neuromuscular contractions in the pelvic floor which may either increase muscle bulk or tone muscles to improve their ability to support the organs. With research suggesting that IVES may be effective at treating UI and at increasing pelvic floor muscle strength, it is possible that IVES may be an effective treatment for mild-to-moderate POP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123982 0
Prof Anna Rosamilia
Address 123982 0
Monash Health - Moorabbin Hospital
823-865 Centre Rd,
Bentleigh East
VIC 3165
Country 123982 0
Australia
Phone 123982 0
+61 3 9928 8785
Fax 123982 0
Email 123982 0
annarosamilia@urogyn.com.au
Contact person for public queries
Name 123983 0
Mr Ritesh Warty
Address 123983 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 123983 0
Australia
Phone 123983 0
+61 404222456
Fax 123983 0
Email 123983 0
ritesh.warty1@monash.edu
Contact person for scientific queries
Name 123984 0
Mr Ritesh Warty
Address 123984 0
Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168
Country 123984 0
Australia
Phone 123984 0
+61 404222456
Fax 123984 0
Email 123984 0
ritesh.warty1@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.