Pelvic Organ ProlapseNCT01776580
The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function
An observational study of Pelvic Organ Prolapse and Sexual Dysfunction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Sexual Dysfunction, Lower Urinary Tract Symptoms
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Dec 2017
- Phase
- Observational
- 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with lower urinary tract symptoms
Who may be able to join
- all patients with lower urinary tract symptoms and will undergo urodynamic studies
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, Taiwan, 100
Ho-Hsiung Lin, MD, PhD, +886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw
Ho-Hsiung Lin, MD,PhD
About this study
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.
Read the detailed description
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.
- Keywords
- Pelvic organ prolapse, lower urinary tract symptoms, sexual dysfunction
- Medical subject headings
- Pelvic Organ Prolapse, Sexual Dysfunction, Physiological, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lower urinary tract symptoms | Women with lower urinary tract symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the correlation of bladder descent and lower urinary tract symptoms.
To assess the correlation of bladder descent and lower urinary tract symptoms, and identify which symptoms is best correlated with bladder descent during Valsalva maneuver.
Measured: 1 day
Secondary outcomes (1)
To identify the correlation of bladder descent with sexual dysfunction.
To identify which parameters of sexual dysfunction is best correlated with the bladder descent.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJul 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, MD, PhD, Principal investigator, Department of Obstetrics & Gynecology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776580
- Sponsor's protocol ID
- 201107060RC
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2013
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function
- ClinicalTrials.gov ID
- NCT01776580
- Acronym / sponsor ID
- 201107060RC
- Keywords
- Pelvic organ prolapse, lower urinary tract symptoms, sexual dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Jan 2013 (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.
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.
Detailed description
Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower urinary tract symptoms | – | –Women with lower urinary tract symptoms |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower urinary tract symptoms
Key inclusion criteria (1 listed)
- all patients with lower urinary tract symptoms and will undergo urodynamic studies
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the correlation of bladder descent and lower urinary tract symptoms.
Time frame: 1 day
To assess the correlation of bladder descent and lower urinary tract symptoms, and identify which symptoms is best correlated with bladder descent during Valsalva maneuver.
1 secondary outcome
To identify the correlation of bladder descent with sexual dysfunction.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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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. This study is not recruiting at the moment.
Ho-Hsiung Lin, MD, PhD principal investigator
Department of Obstetrics & Gynecology, National Taiwan University Hospital
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 Organ Prolapse and Sexual Dysfunction, run by National Taiwan University 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 26 Jan 2016. 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 Ho-Hsiung Lin, MD, PhD (+886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the correlation of bladder descent and lower urinary tract symptoms. (time frame: 1 day). 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 26 Jan 2016.