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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pelvic organ prolapse

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Renal and Urogenital

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]

Treatment: Devices

Intervention code [2]

Rehabilitation

Comparator / control treatment

Not applicable.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Assessed continuously during stimulation

Secondary outcome [1]

Stimulation frequency determined by accessing device settings

Timepoint [1]

Assessed continuously during stimulation

Secondary outcome [2]

Pain/discomfort perceived by participants using 11-point visual analog scale

Timepoint [2]

Immediately post-stimulation

Secondary outcome [3]

Side effects experienced by participants using a study-specific questionnaire. Examples include pain, irritation, discomfort, and bleeding.

Timepoint [3]

Immediately post-stimulation

Secondary outcome [4]

Patient feedback on device experience and overall acceptability using a study-specific questionnaire

Timepoint [4]

Immediately post-stimulation

Secondary outcome [5]

Clinician feedback on device experience using a study-specific questionnaire

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Moorabbin campus - East Bentleigh

Recruitment postcode(s) [1]

3165 - East Bentleigh

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Norman Beischer Medical Research Foundation

Address [1]

459 Toorak Rd, Toorak VIC 3142

Country [1]

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]

Hospital

Name [1]

Monash Health

Address [1]

Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

Research Support Services,
Level 2, i Block,
Monash Medical Centre,
246 Clayton Road,
Clayton, VIC, 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2023

Approval date [1]

Ethics approval number [1]

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

Prof Anna Rosamilia

Address

Monash Health - Moorabbin Hospital
823-865 Centre Rd,
Bentleigh East
VIC 3165

Country

Australia

Phone

+61 3 9928 8785

Fax

[email protected]

Contact person for public queries

Name

Ritesh Warty

Address

Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168

Country

Australia

Phone

+61 404222456

Fax

[email protected]

Contact person for scientific queries

Name

Ritesh Warty

Address

Department of Obstetrics and Gynaecology, Monash University,
Monash Medical Centre, 246 Clayton Road,
Clayton, VIC, 3168

Country

Australia

Phone

+61 404222456

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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