Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05627726 |
| Other study ID # |
HMRF PolyU |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
February 28, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
The Hong Kong Polytechnic University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aims: (1) Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for
improving SUI symptom severity in women; (2) Compare the cost-effectiveness of the PelviSense
device against PFMT alone for treating SUI in women; (3) Explore the views of women regarding
the use of the PelviSense device as an adjunct to PFMT and the impacts of the PelviSense
device on their lives and well-being.
Design and subjects: A sequential, embedded, experimental mixed-methods design, including a
randomised controlled trial (RCT) and semi-structured focus groups, will be conducted
alongside an economic evaluation. The proposed study will include 142 women with SUI or
stress-predominant mixed urinary incontinence.
Interventions: Women will be randomly allocated to one of two groups (PelviSense or PFMT
alone [control]). The PelviSense group will perform PFMT with assistance from the PelviSense
device, and the control group will perform PFMT without biofeedback (i.e., PFMT alone).
Outcome measures: International Consultation on Incontinence Questionnaire-Short Form,
one-hour pad test, Modified Oxford Scale, EQ-5D-5L, and electronic cost diary.
Data analysis and expected results: Statistical analysis will be conducted using analysis of
covariance. The PelviSense group is expected to report significant improvements in primary
and secondary outcomes compared with the PFMT alone group. The PelviSense group will yield
cost savings and result in lower health care utility compared with the PFMT alone group.
Description:
Background Pelvic floor muscle (PFM) training (PFMT) is a common conservative first-line
treatment for SUI in women. However, the success of PFMT alone, without adjunctive therapies,
has been hampered by the lack of training adherence among patients, who report the inability
to contract the correct PFMs and limited motivation to perform PFMT exercises. Therefore,
PFMT is often combined with adjunctive therapies, such as electromyography (EMG) biofeedback
via an intravaginal probe (referred to as conventional biofeedback), transvaginal electrical
stimulation (TVES), or weighted vaginal cones. However, PFMT adjunctive therapies that
involve intravaginal probes/ cones are not preferred by women because they are invasive, and
the vaginal insertion of probes/ cones can cause pain and discomfort. In addition, older
women with atrophic vaginas have difficulty retaining probe/cones within the vaginal canal
due to weak PFM tone.
To meet the existing need for a non-invasive PFMT adjunctive therapy, the research team
developed the PelviSense. The PelviSense is an innovative, non-invasive biofeedback device
with wearable EMG sensors, designed to assist individuals in isolating and strengthening PFMs
by helping them distinguish correct PFM contractions (lifting or squeezing the muscles) from
incorrect attempts (bearing down). A mixed-methods study, including a full-scale RCT and
semi-structured focus groups, alongside an economic evaluation, will be conducted to evaluate
both the effectiveness and cost-effectiveness of the newly developed PelviSense device for
the treatment of SUI in women.
Aims:
Aim 1: Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for
improving SUI symptom severity in women.
Aim 2: Compare the cost-effectiveness of the PelviSense device against PFMT alone for
treating SUI in women.
Aim 3: Explore the views of women regarding the use of the PelviSense device as an adjunct to
PFMT and the impacts of the PelviSense device on their lives and well-being.
Methods Recruitment: Women with SUI who attend the outpatient Obstetrics and Gynecology
Department of Kwong Wah Hospital (KWH) will be recruited for the study. In addition,
potential participants will be recruited using a non-probability convenience sampling
technique through public, KWH, elderly care centers, and HK Polytechnic University (PolyU)
campus advertising. Advertising will consist of study flyers posted at KWH, around the
university campus, in waiting rooms of university health services and physiotherapy clinics,
in community churches, and in university-owned amenities, including sports centres and gyms.
Randomisation and blinding: Computer-generated randomisation will be utilised to ensure that
both study groups are assigned an equal number of participants at a 1:1 ratio. Sequentially
numbered, sealed, opaque envelopes of similar size and shape will be utilised to conceal
group allocation and avoid selection bias. Due to the nature of the intervention, it is not
possible to blind the therapists or participants to the allocation of treatment; therefore,
only the outcome assessor will be blinded. To minimise detection bias, the outcome assessors
will not participate in the treatment, and all study outcomes will be assessed in a separate
room without any knowledge of participant allocation. Statistical analysis will be performed
in a blinded manner, with each group assigned a code (group A and group B). The group
identities will be revealed after all analyses are completed.
Procedure and baseline assessment: Potentially eligible women who contact research personnel
will be invited to attend an in-person screening session. On this first day of contact, all
women will undergo BMI measurement; complete the screening questionnaire, MMSE, and 1-h pad
test to confirm eligibility; and provide written informed consent. Baseline assessments of
study outcomes will be performed, and eligible and consenting participants will be randomised
to intervention groups.
Outcome measures Outcomes assessments will be completed at baseline (time point 1 [T1]),
1-month (T2) and 6-months (T3).
Intervention. The interventions will be provided for 6 months, beginning with a 1-month
supervised training period at KWH and PolyU. Following supervised training, women will be
instructed to perform unsupervised home exercises for 5 months. Unsupervised home exercises
will consist of at least eight contractions, performed 3 times per day, for 5 days of each
week, with or without the biofeedback device according to group assignment. Each contraction
will last for 10 seconds, followed by relaxation for 10 seconds. The PFMT exercise parameters
are based on the National Institute for Health and Care Excellence PFMT guidelines for UI.
Qualitative study (semi-structured focus groups). A computer-generated randomization schedule
will be utilized to identify 20 participants (from the 71 participants included in the
PelviSense-assisted PFMT group) to participate in the focus groups. Each focus group will
last for 45-60 minutes. Focus groups will continue to be conducted until data saturation
occurs. Focus groups will be scheduled for 8-months post-randomisation. A semi-structured
focus group approach will be used, during which discussion will be guided by but not limited
to a set of pre-determined, open-ended questions.
Data processing and analysis: Statistical analysis will be performed on an intention-to-treat
basis using the Statistical Package for the Social Sciences (v.25; Armonk, NY).
Treatment effects for both primary and secondary outcomes between T1, T2, and T3 and across
the intervention groups will be evaluated using a two-way analysis of covariance (ANCOVA)
with age as the covariate. T1 and T2 will be compared to establish immediate treatment
effects, and T1 and T3 will be compared to evaluate the retention of treatment effects. For
significant group by time interaction effects, post-hoc analysis using Bonferroni correction
will be performed.
The unadjusted mean total and disaggregated costs and differences in costs between the
PelviSense and PFMT alone groups will be calculated. Seemingly unrelated regression (SUR)
analyses will be used to estimate total cost differences (ΔC) and effect differences (ΔE).
The EQ-5D-5L responses will be converted into utility scores to estimate the gain or loss of
quality-adjusted life-years (QUALYs). The incremental cost-effectiveness ratio (ICER) will be
calculated using the formula ICER = ΔC / ΔE. Uncertainty surrounding ICERs and 95% confidence
intervals for cost differences will be estimated using bias-corrected and accelerated
bootstrapping with 5,000 replications.
Qualitative data from the focus groups will be analysed using the six phases of thematic
analysis recommended by Braun and Clarke. The identified themes will then be defined and
named according to their contents. The final set of themes will be confirmed as coherent and
comprehensive by review of the team.
