Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-04 @ 3:14 AM
Study NCT ID:
NCT02185235
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
Sponsor:
Mackay Memorial Hospital
Organization:
Study Overview
Official Title:
To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: