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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofeedback & Electrical Stimulation | Experimental | Twice a week, 20 minutes for each time. One course includes 18 times treatment. |
|
| Biofeedback & Pelvic Floor Training | Active Comparator | Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Total 18 times of treatment, for 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (score) | Total 18 times of treatment, for 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Urodynamics data analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsung-Hsien Su, PhD | Contact | 886-25433535 | 2544 | drthsu@mail.itrip.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| TSUNG H Su, Professor | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiwan, Taipei, Mackay Memorial hospital | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39170685 | Derived | 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. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
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|
|
| Biofeedback | 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 | 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. |
|
Use urodyanmic examinations for evaluation of bladder function
| Total 18 times of treatment, for 3 months |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |