A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
1 other identifier
interventional
200
1 country
1
Brief Summary
Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse (POP), and fecal incontinence-which often occur together. Pelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women. Surgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies. This may be because of higher awareness among women and cost of and morbidity after surgery. The conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback. The outcome was up to 35\~70 % improved rate as the literature before. Current guidelines recommended conservative management as a first-line therapy. However, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies. Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.). At the aspect of Quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedNovember 7, 2022
November 1, 2022
10 years
June 11, 2014
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-Hour Pad test of urine leakage amount (gm)
A pad test is a tool to used to measure urine leakage amount . Pad testing can be done over a period of time to one hour. A sanitary napkin is weighed and then worn for sixty minutes, during which time the individual is asked to perform certain activities which may include: * Walking briskly for three minutes * Sitting and then standing ten to twenty times * Walking up and down stairs for one to two minutes * Picking up objects from the floor five to ten times * Coughing twelve times (at various strengths; may be repeated) * Running in place for one minute (may be repeated) The pad is then removed and weighed again to calculate the amount of urine voided.
Total 18 times of treatment, for 3 months
Secondary Outcomes (1)
Quality of life (score)
Total 18 times of treatment, for 3 months
Other Outcomes (2)
Vaginal pressure (mmHg)
Total 18 times of treatment, for 3 months
Urodynamics data analysis
Total 18 times of treatment, for 3 months
Study Arms (2)
Biofeedback & Electrical Stimulation
EXPERIMENTALTwice a week, 20 minutes for each time. One course includes 18 times treatment.
Biofeedback & Pelvic Floor Training
ACTIVE COMPARATORPelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.
Interventions
The Chartered Society of Physiotherapy recommends the following standard for electrical devices. Frequency: 35 Hertz. Pulse width: 250µs (0.25ms). Current type: bi-phasic rectangular. Intensity: maximum tolerated. Duty-cycle: 5 seconds on/10 seconds off. Very weak muscles: 5 seconds on/15 seconds off. Treatment time: 5 minutes initially, gradually increasing to 20 minutes.
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
First, as you are sitting or lying down, try to contract the muscles you would use to stop urinating To contract the pelvic muscles, squeeze for 3 seconds and then relax for 3 seconds. Repeat this exercise to 20 minutes each session.
Eligibility Criteria
You may qualify if:
- Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.
You may not qualify if:
- Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taiwan, Taipei, Mackay Memorial hospital
Taipei, Taiwan
Related Publications (1)
Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Effect of intra-vaginal electric stimulation on bladder compliance in stress urinary incontinence patients: the involvement of autonomic tone. Front Neurosci. 2024 Aug 7;18:1432616. doi: 10.3389/fnins.2024.1432616. eCollection 2024.
PMID: 39170685DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TSUNG H Su, Professor
Mackay Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mackay Memorial Hospital
Study Record Dates
First Submitted
June 11, 2014
First Posted
July 9, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2024
Study Completion
May 1, 2025
Last Updated
November 7, 2022
Record last verified: 2022-11