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

NCT ID: NCT02185235

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2025-05-31

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.

Conditions

Pelvic Organ Prolapse; Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biofeedback & Electrical Stimulation

Twice a week, 20 minutes for each time. One course includes 18 times treatment.

Group Type: EXPERIMENTAL

Electrical Stimulation

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Biofeedback & Pelvic Floor Training

Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.

Group Type: ACTIVE_COMPARATOR

Biofeedback

Intervention Type: DEVICE

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

Pelvic Floor Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

Biofeedback

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Femiscan Stim (Mega Electronics Ltd); Femiscan Multi-trainer

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tsung-Hsien Su

Mackay Memorial Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TSUNG H Su, Professor

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

Taiwan, Taipei, Mackay Memorial hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tsung-Hsien Su, PhD

Role: CONTACT

drthsu@mail.itrip.com.tw

886-25433535 ext. 2544

References

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.

Reference Type: DERIVED

PMID: 39170685 (View on PubMed)

Other Identifiers

14MMHIS031

Identifier Type: -

Identifier Source: org_study_id