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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02185235
• Other study ID #: 14MMHIS031
• Status: Recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2025

Study information

• Verified date: November 2022
• Source: Mackay Memorial Hospital
• Contact: Tsung-Hsien Su, PhD
• Phone: 886-25433535
• Email: drthsu[@]mail.itrip.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Incontinence
• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• Biofeedback
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies

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.

Locations

Country	Name	City	State
Taiwan	Taiwan, Taipei, Mackay Memorial hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vaginal pressure (mmHg)	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
Other	Urodynamics data analysis	Use urodyanmic examinations for evaluation of bladder function	Total 18 times of treatment, for 3 months
Primary	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	Quality of life (score)		Total 18 times of treatment, for 3 months