Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126757
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-06
Brief Title:
PelviSense an Innovative Non-invasive Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
An Innovative Non-invasive Biofeedback Device for the Treatment of Stress Urinary Incontinence in Women Evaluation and Mechanism Testing
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background and purpose The research team developed the PelviSense a non-invasive biofeedback device paired with wearable EMG sensors for use as a PFMT adjunct The proposed study aims to 1 investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT on SUI in women and 2 identify the mechanisms underlying the beneficial effects of PFMT for the treatment of SUI Methods A two-arm parallel-group RCT will be conducted using 132 non-pregnant women with SUI aged 18-60 years The study participants will be randomised into two study groups PelviSense-assisted PFMT or unassisted PFMT Women will be supervised in the performance of PelviSense-assisted and unassisted PFMT on a 11 basis for 4 weeks and instructed to perform unsupervised home exercises for 24 weeks after the completion of supervised training The primary outcome will be the severity of urine loss as measured using the one-hour pad test Secondary outcomes will include quality of life SUI symptoms severity and PFM strength as measured using the incontinence impact questionnaire short-form international consultation on incontinence questionnaire short-form and modified Oxford scale respectively Mediator variables will include the following bladder neck elevation and levator hiatus area Outcomes and mediator variables will be assessed at baseline 4 and 28 weeks Statistical analysis Treatment and mediation effects will be evaluated using analysis of covariance and the Hayes PROCESS macro respectively
Detailed Description:
Background and purpose Stress urinary incontinence SUI is a common condition among women resulting in urine leakage during physical exertion sneezing or coughing Due to the risks associated with surgical and pharmacological treatments women with SUI often prefer conservative treatments such as pelvic floor muscle PFM training PFMT PFMT has been shown to provide increased beneficial effects when combined with electromyography EMG biofeedback referred to as conventional biofeedback CB via intravaginal probe than when performed alone However the CB device applied in clinical practice is not preferred by women because it is invasive and involves the insertion of a probe into the vagina causing pain discomfort Therefore we developed the PelviSense a non-invasive biofeedback device paired with wearable EMG sensors for use as a PFMT adjunct
The proposed study aims to 1 investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT on SUI in women and 2 identify the mechanisms underlying the beneficial effects of PFMT for the treatment of SUI
Hypotheses 1 women assigned to the PelviSense-assisted PFMT group will report a greater reduction in the severity of urine loss compared with women assigned to the unassisted PFMT group and 2 improvements in the severity of urine loss will be mediated by increased PFM strength causing an increase in bladder neck elevation and a reduction in levator hiatus LH area during the Valsalva manoeuvre
Methods A two-arm parallel-group RCT will be conducted using 132 non-pregnant women with SUI aged 18-60 years The study participants will be randomised into two study groups PelviSense-assisted PFMT or unassisted PFMT Women will be supervised in the performance of PelviSense-assisted and unassisted PFMT on a 11 basis for 4 weeks and instructed to perform unsupervised home exercises for 24 weeks after the completion of supervised training
Recruitment Potential participants will be recruited using a non-probability convenience sampling technique through public and university campus advertising
Randomisation and blinding An individual who will not be involved in study recruitment will randomly assign participants to one of the two study groups PelviSense assisted PFMT or unassisted PFMT at a 11 ratio Another individual will assign treatments according to a computer-generated random schedule in permuted blocks of two within age strata The allocation sequence will be concealed using sealed opaque sequentially numbered envelopes containing the group name and a personal identification number To eliminate expectation effects and biases a research assistant RA will complete the assessment of primary outcomes and intervention training and supervision at HK PolyU will be conducted by a physiotherapy research postgraduate RPg student Raw data will be double entered into a spreadsheet by a student assistant Data analysis will be completed in a blinded manner with code names Groups A and B used for each group and group identities will only be revealed after the analysis has been completed
Procedure and baseline assessment Potential participants will be invited to an in-person visit at HK PolyU On the first day of contact the participants will complete a screening questionnaire and a 1-h pad test to determine eligibility Written informed consent and body mass index BMI measurements will also be obtained The 1-h pad test International Consultation on Incontinence Questionnaire Short Form ICIQ-SF the Incontinence Impact Questionnaire Short Form IIQ-7 and the MOS will be used to establish baseline severity of urine loss SUI symptoms severity QoL and PFM strength respectively Participants will undergo a transabdominal ultrasound TAU to measure baseline bladder neck elevation and LH area during a Valsalva manoeuvre cough Following baseline assessments participants will select an envelope containing treatment allocation details
Outcome measures The primary outcome will be the severity of urine loss as measured using the one-hour pad test Secondary outcomes will include quality of life SUI symptoms severity and PFM strength as measured using the incontinence impact questionnaire short-form international consultation on incontinence questionnaire short-form and modified Oxford scale respectively Mediator variables will include the following bladder neck elevation and levator hiatus area Outcomes and mediator variables will be assessed at baseline 4 and 24 weeks Statistical analysis Treatment and mediation effects will be evaluated using analysis of covariance and the Hayes PROCESS macro respectively
Statistical analysis Hypothesis 1 Treatment effects on both primary and secondary outcomes between T1 T2 and T3 and across the intervention groups will be evaluated using analysis of covariance ANCOVA
Hypothesis 2 Mediation analyses will be conducted using the Hayes PROCESS SPSS macro v213 Model 4
The proposed study aims to 1 investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT on SUI in women and 2 identify the mechanisms underlying the beneficial effects of PFMT for the treatment of SUI
Hypotheses 1 women assigned to the PelviSense-assisted PFMT group will report a greater reduction in the severity of urine loss compared with women assigned to the unassisted PFMT group and 2 improvements in the severity of urine loss will be mediated by increased PFM strength causing an increase in bladder neck elevation and a reduction in levator hiatus LH area during the Valsalva manoeuvre
Methods A two-arm parallel-group RCT will be conducted using 132 non-pregnant women with SUI aged 18-60 years The study participants will be randomised into two study groups PelviSense-assisted PFMT or unassisted PFMT Women will be supervised in the performance of PelviSense-assisted and unassisted PFMT on a 11 basis for 4 weeks and instructed to perform unsupervised home exercises for 24 weeks after the completion of supervised training
Recruitment Potential participants will be recruited using a non-probability convenience sampling technique through public and university campus advertising
Randomisation and blinding An individual who will not be involved in study recruitment will randomly assign participants to one of the two study groups PelviSense assisted PFMT or unassisted PFMT at a 11 ratio Another individual will assign treatments according to a computer-generated random schedule in permuted blocks of two within age strata The allocation sequence will be concealed using sealed opaque sequentially numbered envelopes containing the group name and a personal identification number To eliminate expectation effects and biases a research assistant RA will complete the assessment of primary outcomes and intervention training and supervision at HK PolyU will be conducted by a physiotherapy research postgraduate RPg student Raw data will be double entered into a spreadsheet by a student assistant Data analysis will be completed in a blinded manner with code names Groups A and B used for each group and group identities will only be revealed after the analysis has been completed
Procedure and baseline assessment Potential participants will be invited to an in-person visit at HK PolyU On the first day of contact the participants will complete a screening questionnaire and a 1-h pad test to determine eligibility Written informed consent and body mass index BMI measurements will also be obtained The 1-h pad test International Consultation on Incontinence Questionnaire Short Form ICIQ-SF the Incontinence Impact Questionnaire Short Form IIQ-7 and the MOS will be used to establish baseline severity of urine loss SUI symptoms severity QoL and PFM strength respectively Participants will undergo a transabdominal ultrasound TAU to measure baseline bladder neck elevation and LH area during a Valsalva manoeuvre cough Following baseline assessments participants will select an envelope containing treatment allocation details
Outcome measures The primary outcome will be the severity of urine loss as measured using the one-hour pad test Secondary outcomes will include quality of life SUI symptoms severity and PFM strength as measured using the incontinence impact questionnaire short-form international consultation on incontinence questionnaire short-form and modified Oxford scale respectively Mediator variables will include the following bladder neck elevation and levator hiatus area Outcomes and mediator variables will be assessed at baseline 4 and 24 weeks Statistical analysis Treatment and mediation effects will be evaluated using analysis of covariance and the Hayes PROCESS macro respectively
Statistical analysis Hypothesis 1 Treatment effects on both primary and secondary outcomes between T1 T2 and T3 and across the intervention groups will be evaluated using analysis of covariance ANCOVA
Hypothesis 2 Mediation analyses will be conducted using the Hayes PROCESS SPSS macro v213 Model 4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None