A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder

November 2, 2022 updated by: Tsung-Hsien Su, Mackay Memorial Hospital

To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taiwan, Taipei, Mackay Memorial hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

  • Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback & Electrical Stimulation
Twice a week, 20 minutes for each time. One course includes 18 times treatment.
Device: Electrical Stimulation

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.

Other Names:
  • Femiscan Stim (Mega Electronics Ltd)
Device: Biofeedback
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
Other Names:
  • Femiscan Multi-trainer
Active Comparator: Biofeedback & Pelvic Floor Training
Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.
Device: Biofeedback
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
Other Names:
  • Femiscan Multi-trainer
Other: Pelvic Floor Training

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Hour Pad test of urine leakage amount (gm)
Time Frame: Total 18 times of treatment, for 3 months

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 Outcome Measures

Outcome Measure
Time Frame
Quality of life (score)
Time Frame: Total 18 times of treatment, for 3 months
Total 18 times of treatment, for 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal pressure (mmHg)
Time Frame: Total 18 times of treatment, for 3 months
Use the vaginal probe sensor to evaluate the objective level of vaginal squeezing pressure and endurance time
Total 18 times of treatment, for 3 months
Urodynamics data analysis
Time Frame: Total 18 times of treatment, for 3 months
Use urodyanmic examinations for evaluation of bladder function
Total 18 times of treatment, for 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: TSUNG H Su, Professor, Mackay Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

July 3, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14MMHIS031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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