NCT02185235

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2024-06-01
• Completion: 2025-05-01
• First posted: 2014-07-09
• Last updated: 2022-11-07

Locations

1 site across 1 country: Taiwan