Pelvic Organ Prolapse Clinical Trial
Official title:
To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
NCT number | NCT02185235 |
Other study ID # | 14MMHIS031 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | May 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taiwan, Taipei, Mackay Memorial hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital |
Taiwan,
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 |
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