Pelvic Floor DisordersNCT00884871
Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders
An observational study of Pelvic Floor Disorders, run by University of California, San Diego at 1 site in United States.
Trial summary
The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- LapBand
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2009
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 obese women who have met surgical eligibility for laparoscopic adjustable gastric banding at the Center for the Treatment of Obesity at UCSD
Who may be able to join
- surgical eligibility met by Center for the Treatment Obesity criteria
- morbid obesity (BMI > 40 kg/m2) or severe obesity (BMI > 33 kg/m2) in presence of NIH co-morbidities
- willing to participate in study, including completion of self-reported questionnaires
Who cannot join
- pregnancy or planned pregnancy
- recent pregnancy or pelvic surgery
- age < 21 years
- known neurologic disease or pelvic pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Medical Center
La Jolla, California, 92037
About this study
Official title: A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders
The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and super-obese women using a prospective, observational study design.
- Conditions
- Pelvic Floor Disorders
- Being tested
- LapBand
- Keywords
- pelvic floor disorders, weight loss
- Medical subject headings
- Pelvic Floor Disorders, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapBandProcedure or surgery
Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic adjustable gastric banding | 100 obese women undergoing laparoscopic adjustable gastric banding Receives: Procedure: LapBand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire
Measured: 12 months
Secondary outcomes (3)
Weekly incontinence episodes and pad use ascertained by incontinence diary
Measured: 12 months
Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I)
Measured: 12 months
Sexual function ascertained by validated measure (PISQ)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startSep 2007
- Primary completionNov 2009
- Study completionNov 2009
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 University of California, San DiegoThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Emily L Whitcomb, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884871
- Sponsor's protocol ID
- 071113
- Status last verified
- Nov 2009
- First submitted
- 20 Apr 2009
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT00884871
- Acronym / sponsor ID
- 071113
- Conditions
- Pelvic Floor Disorders
- Keywords
- pelvic floor disorders, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Apr 2009 (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.
The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and super-obese women using a prospective, observational study design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic adjustable gastric banding | – | Procedure: LapBand100 obese women undergoing laparoscopic adjustable gastric banding |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 obese women who have met surgical eligibility for laparoscopic adjustable gastric banding at the Center for the Treatment of Obesity at UCSD
Key inclusion criteria (3 listed)
- surgical eligibility met by Center for the Treatment Obesity criteria
- morbid obesity (BMI > 40 kg/m2) or severe obesity (BMI > 33 kg/m2) in presence of NIH co-morbidities
- willing to participate in study, including completion of self-reported questionnaires
Key exclusion criteria (4 listed)
- pregnancy or planned pregnancy
- recent pregnancy or pelvic surgery
- age < 21 years
- known neurologic disease or pelvic pathology
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 |
|---|---|---|
| LapBandProspective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders | Procedure or surgery | Laparoscopic adjustable gastric banding |
Primary outcome
Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire
Time frame: 12 months
3 secondary outcomes
Weekly incontinence episodes and pad use ascertained by incontinence diary
Time frame: 12 months
Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I)
Time frame: 12 months
Sexual function ascertained by validated measure (PISQ)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
Related trials for Pelvic Floor Disorders
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
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.
Emily L Whitcomb, M.D. principal investigator
University of California, San Diego
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, run by University of California, San Diego at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 11 Nov 2009. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire (time frame: 12 months). 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 11 Nov 2009.