Pelvic Organ ProlapseNCT02185235
A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
A study testing Electrical Stimulation, Biofeedback and Pelvic Floor Training in people with Pelvic Organ Prolapse and Incontinence, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Incontinence
- What is being tested?
- Electrical Stimulation, Biofeedback and Pelvic Floor Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.
Who cannot join
- Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taiwan, Taipei, Mackay Memorial hospital
Taipei
About this study
Official title: To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
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.
Read more
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
- Being tested
- Electrical Stimulation, Biofeedback, Pelvic Floor Training
- Keywords
- Electrical stimulation, Biofeedback
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationDevice
Also called Femiscan Stim (Mega Electronics Ltd)
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.
BiofeedbackDevice
Also called Femiscan Multi-trainer
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
Pelvic Floor TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback & Electrical Stimulation | Experimental | Twice a week, 20 minutes for each time. One course includes 18 times treatment. Receives: Device: Electrical Stimulation; Device: Biofeedback |
| Biofeedback & Pelvic Floor Training | Active comparator | Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times. Receives: Device: Biofeedback; Other: Pelvic Floor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Total 18 times of treatment, for 3 months
Secondary outcomes (1)
Quality of life (score)
Measured: Total 18 times of treatment, for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsung-Hsien Su, Mackay Memorial Hospital
- Investigators
- TSUNG H Su, Professor, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185235
- Sponsor's protocol ID
- 14MMHIS031
- Status last verified
- Nov 2022
- First submitted
- 11 Jun 2014
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39170685
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
- ClinicalTrials.gov ID
- NCT02185235
- Acronym / sponsor ID
- 14MMHIS031
- Conditions
- Pelvic Organ Prolapse, Incontinence
- Keywords
- Electrical stimulation, Biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback & Electrical Stimulation | Experimental | Device: Electrical Stimulation, Device: BiofeedbackTwice a week, 20 minutes for each time. One course includes 18 times treatment. |
| Biofeedback & Pelvic Floor Training | Active comparator | Device: Biofeedback, Other: Pelvic Floor TrainingPelvic floor training every 20 minutes for each time, twice a week. and total for 18 times. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.
Key exclusion criteria (1 listed)
- Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical StimulationAlso: Femiscan Stim (Mega Electronics Ltd)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 & Electrical Stimulation |
| BiofeedbackAlso: Femiscan Multi-trainerBiofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies | Device | Biofeedback & Electrical Stimulation, Biofeedback & Pelvic Floor Training |
| Pelvic Floor TrainingFirst, 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. | Other | Biofeedback & Pelvic Floor Training |
Primary outcome
1-Hour Pad test of urine leakage amount (gm)
Time frame: Total 18 times of treatment, for 3 months
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.
1 secondary outcome
Quality of life (score)
Time frame: Total 18 times of treatment, for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Derived from this study: PubMed 39170685Lau 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.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TSUNG H Su, Professor principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation, Biofeedback and Pelvic Floor Training in people with Pelvic Organ Prolapse and Incontinence, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsung-Hsien Su, PhD (886-25433535 ext. 2544, drthsu@mail.itrip.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Hour Pad test of urine leakage amount (gm) (time frame: Total 18 times of treatment, for 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.