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Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence, Urethral Hypermobility, Intrinsic Sphincter Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
surface electromyographic biofeedback assisted pelvic floor muscle training
surface electromyographic biofeedback and electrical stimulation
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. overactivity bladder for more than 3 months
  2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
  3. need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises

Exclusion Criteria:

  1. Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
  2. Kidney disease
  3. Liver disease
  4. Patients with cardiac rhythm devices.
  5. Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises.
  6. Women during pregnancy.
  7. Maternity within six weeks after delivery

Sites / Locations

  • Far Eastern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

urethral hypermobility-surface electromyographic biofeedback only

urethral hypermobility-surface electromyographic biofeedback and electrical stimulation

intrinsic sphincter deficiency-surface electromyographic biofeedback only

intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation

Arm Description

Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months

Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months

Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months

Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months

Outcomes

Primary Outcome Measures

King's Health Questionnaire (KHQ)
KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 .
A five-item Self-Assessment of Treatment (SAT)
to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .
Sandvik urinary incontinence severity test
The Sandvik test was developed by Sandvik et al to be used as a simple way to calculate severity of urinary incontinence in women. Answer the two questions below and your result will be displayed (Severity Index Score).
Symptom Indexes for Stress Incontinence
assigning a grade based on a clinical history of incontinence: grade 1-only on Severe coughing, sneezing, lifting heavy objects, lifting heavy objects, jumping; grade 2-on walking or running; grade 3-on walking, doing housework (eg washing dishes, sweeping the floor), changing posture (eg from standing to squatting or sitting...);grade 4-on Resting state, such as turning over in bed

Secondary Outcome Measures

Introital and transvaginal ultrasound in the assessment of urogenital and pelvic floor dysfunction
the transducer is placed over the external urethral orifice with the transducer axis corresponding to the body axis Ultrasound assessment of the bladder and urethra starts in the midsagittal plane. From this position, the transducer can be moved to the left or to the right for additional assessment of the periurethral tissue. The distance between bladder neck and line through the lower edge of the pubic symphysis, and the posterior urethrovesical angle β (angle between urethral axis and bladder floor) are determined at rest and during contraction, coughing, and pressing. Changes in these parameters during contraction and pressing and in particular visual real-time ultrasound assessment serve to evaluate the reactivity of the pelvic floor muscles and the adequacy of the connective tissue supportive structures of the urogenital organs.
one-hour pad test
The test is carried out according to the recommendations of the International Continence Society and lasts for one hour and fifteen minutes. It consists in weighing the amount of urine retained in a sanitary napkin after the patient has completed a set of standard exercises, distributed over an hour.
change of electromyographic activity
Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)

Full Information

First Posted
February 28, 2022
Last Updated
March 20, 2023
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05272644
Brief Title
Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence
Official Title
Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Different Pathophysiological Classifications of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Far Eastern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. Electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. This study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.
Detailed Description
Participant will be assigned randomly to biofeedback-assisted pelvic floor muscle training (PFMT) group and biofeedback-assisted pelvic floor muscle training (PFMT) combined with electrical stimulation group. Each of the participant will receive the therapy for two months.The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with stress urinary incontinence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Urethral Hypermobility, Intrinsic Sphincter Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 128 women with stress urinary incontinence will be divided into two groups: urethral hypermobility and intrinsic sphincter deficiency; and they will be further randomized to 2 arms: surface electromyographic biofeedback arm, surface electromyographic biofeedback and electrical stimulation arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
urethral hypermobility-surface electromyographic biofeedback only
Arm Type
Active Comparator
Arm Description
Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months
Arm Title
urethral hypermobility-surface electromyographic biofeedback and electrical stimulation
Arm Type
Experimental
Arm Description
Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months
Arm Title
intrinsic sphincter deficiency-surface electromyographic biofeedback only
Arm Type
Active Comparator
Arm Description
Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months
Arm Title
intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation
Arm Type
Experimental
Arm Description
Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months
Intervention Type
Behavioral
Intervention Name(s)
surface electromyographic biofeedback assisted pelvic floor muscle training
Intervention Description
participants will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months
Intervention Type
Behavioral
Intervention Name(s)
surface electromyographic biofeedback and electrical stimulation
Intervention Description
participants will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months
Primary Outcome Measure Information:
Title
King's Health Questionnaire (KHQ)
Description
KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 .
Time Frame
Time Frame: through study completion, an average of 8 weeks
Title
A five-item Self-Assessment of Treatment (SAT)
Description
to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .
Time Frame
Time Frame: through study completion, an average of 8 weeks.
Title
Sandvik urinary incontinence severity test
Description
The Sandvik test was developed by Sandvik et al to be used as a simple way to calculate severity of urinary incontinence in women. Answer the two questions below and your result will be displayed (Severity Index Score).
Time Frame
Time Frame: through study completion, an average of 8 weeks
Title
Symptom Indexes for Stress Incontinence
Description
assigning a grade based on a clinical history of incontinence: grade 1-only on Severe coughing, sneezing, lifting heavy objects, lifting heavy objects, jumping; grade 2-on walking or running; grade 3-on walking, doing housework (eg washing dishes, sweeping the floor), changing posture (eg from standing to squatting or sitting...);grade 4-on Resting state, such as turning over in bed
Time Frame
Time Frame: through study completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Introital and transvaginal ultrasound in the assessment of urogenital and pelvic floor dysfunction
Description
the transducer is placed over the external urethral orifice with the transducer axis corresponding to the body axis Ultrasound assessment of the bladder and urethra starts in the midsagittal plane. From this position, the transducer can be moved to the left or to the right for additional assessment of the periurethral tissue. The distance between bladder neck and line through the lower edge of the pubic symphysis, and the posterior urethrovesical angle β (angle between urethral axis and bladder floor) are determined at rest and during contraction, coughing, and pressing. Changes in these parameters during contraction and pressing and in particular visual real-time ultrasound assessment serve to evaluate the reactivity of the pelvic floor muscles and the adequacy of the connective tissue supportive structures of the urogenital organs.
Time Frame
Time Frame: through study completion, an average of 8 weeks
Title
one-hour pad test
Description
The test is carried out according to the recommendations of the International Continence Society and lasts for one hour and fifteen minutes. It consists in weighing the amount of urine retained in a sanitary napkin after the patient has completed a set of standard exercises, distributed over an hour.
Time Frame
Time Frame: through study completion, an average of 8 weeks
Title
change of electromyographic activity
Description
Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
Time Frame
Time Frame: through study completion, an average of 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: overactivity bladder for more than 3 months more then 20 year old,less then 85 year old and acceptable to receive vaginal examination need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises Exclusion Criteria: Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc. Kidney disease Liver disease Patients with cardiac rhythm devices. Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises. Women during pregnancy. Maternity within six weeks after delivery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Yih Wu
Phone
88689667000
Ext
1424
Email
wenyih@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Far Eastern Memorial Hospital
Phone
88689667000
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence

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