Pelvic Floor DisordersNCT05778552
The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training
An observational study of Pelvic Floor Disorders and Pelvic Organ Prolapse, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Pelvic Organ Prolapse, Stress Urinary Incontinence
- What is being tested?
- Home-based pelvic muscle training devices or traditional PFMT at hospital
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with SUI and Pelvic organ prolapse could be enrolled for study
Who may be able to join
- Age > 18-year-old, non-pregnancy, SUI, bladder capacity > 300ml, RU<150ml, pelvic organ prolapse
Who cannot join
- recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Huann-Cheng Horng, MD, PhD, 886-(2) 2875-7826, hchorng@vghtpe.gov.tw
About this study
Official title: The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training : Prospective Study
When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.
Read the detailed description
The investigators will enroll participants with SUI or POP and allocate them into either the home-based pelvic floor muscle training (PFMT) group or traditional PFMT group. Participant satisfaction will be evaluated using a questionnaire score.
- Being tested
- Home-based pelvic muscle training devices or traditional PFMT at hospital
- Medical subject headings
- Pelvic Floor Disorders, Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based pelvic muscle training devices or traditional PFMT at hospitalDevice
Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital
| Study group | Role | What they receive |
|---|---|---|
| Home-based pelvic muscle training devices group | Patients underwent pelvic muscle training by home-based device and at home. Receives: Device: Home-based pelvic muscle training devices or traditional PFMT at hospital | |
| Traditional pelvic muscle training devices group | Patients underwent traditional pelvic muscle training at hospital Receives: Device: Home-based pelvic muscle training devices or traditional PFMT at hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
The satisfication of pelvic muscle training (UDI-6)
The total score ranges from 0 to 18, with a higher score indicating that the patient experiences a greater degree of urinary distress.
Measured: up to 2 years
The satisfication of pelvic muscle training (ICIQ-SF)
The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
Measured: up to 2 years
The satisfication of pelvic muscle training (IIQ-7)
The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
Measured: up to 2 years
The satisfication of pelvic muscle training (POPDI-6)
POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms
Measured: up to 2 years
The satisfication of pelvic muscle training (PISQ-IR)
The PISQ-IR is a validated questionnaire in research for assessment of female sexual function. A higher score indicates a greater negative impact on sexual function.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Huann-Cheng Horng, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778552
- Sponsor's protocol ID
- 2022-10-004A
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training : Prospective Study
- ClinicalTrials.gov ID
- NCT05778552
- Acronym / sponsor ID
- 2022-10-004A
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Mar 2023 (actual)
- 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.
When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.
Detailed description
The investigators will enroll participants with SUI or POP and allocate them into either the home-based pelvic floor muscle training (PFMT) group or traditional PFMT group. Participant satisfaction will be evaluated using a questionnaire score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based pelvic muscle training devices group | – | Device: Home-based pelvic muscle training devices or traditional PFMT at hospitalPatients underwent pelvic muscle training by home-based device and at home. |
| Traditional pelvic muscle training devices group | – | Device: Home-based pelvic muscle training devices or traditional PFMT at hospitalPatients underwent traditional pelvic muscle training at hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with SUI and Pelvic organ prolapse could be enrolled for study
Key inclusion criteria (1 listed)
- Age > 18-year-old, non-pregnancy, SUI, bladder capacity > 300ml, RU<150ml, pelvic organ prolapse
Key exclusion criteria (1 listed)
- recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems
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 |
|---|---|---|
| Home-based pelvic muscle training devices or traditional PFMT at hospitalPerformed home-based pelvic muscle training devices at home or traditional PFMT at hospital | Device | Home-based pelvic muscle training devices group, Traditional pelvic muscle training devices group |
Primary outcome
The satisfication of pelvic muscle training (UDI-6)
Time frame: up to 2 years
The total score ranges from 0 to 18, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (ICIQ-SF)
Time frame: up to 2 years
The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (IIQ-7)
Time frame: up to 2 years
The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (POPDI-6)
Time frame: up to 2 years
POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms
The satisfication of pelvic muscle training (PISQ-IR)
Time frame: up to 2 years
The PISQ-IR is a validated questionnaire in research for assessment of female sexual function. A higher score indicates a greater negative impact on sexual function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Huann-Cheng Horng principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders and Pelvic Organ Prolapse, run by Taipei Veterans General Hospital, Taiwan 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: looking for participants now, as of the sponsor's last update on 21 Mar 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huann-Cheng Horng (886-(2) 2875-7826, hchorng@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The satisfication of pelvic muscle training (UDI-6) (time frame: up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2023.