None listed
Conditions
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. This study aims to develop a heat map of the optimal intravaginal regions to target with IVES to improve efficacy of IVES.
Interventions
This study is similar to ACTRN12623000134628p with the exception that this study aims to develop a heatmap of the optimal intravaginal/pelvic muscles to stimulate instead of testing efficacy and performance. As part of this study, participants will undergo a single 30 minute session where the stimulation probe will be inserted at various depths and participants will undergo intravaginal electrical stimulation (IVES) using a clinician recommended protocol (patient dependent) with a device (NeuroTrac Continence) 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, NeuroTrac probe insertion depth, the protocol, pelvic floor muscle contraction strength, pain/discomfort, and any adverse events will be recorded. Administration and control of IVES will be performed by a pelvic floor nurse or pelvic floor physiotherapist.
Sponsors
Study design
Eligibility
Inclusion criteria
The women in the following group: 1. Women 18 years of age or above 2. Women with Pelvic Organ Prolapse Quantification System (POP–Q) Stage 2 or 3 3. Women with a ring pessary due for checking or replacement The following criteria are relevant as the women most likely to benefit from the solution are those with these grades of prolapse, and the demographics most likely to suffer from POP are women above 50 years of age or post-partum women
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