Urinary Incontinence,StressNCT03295253
Fat Grafting Technique Using Autologous Adipose Tissue Lipogems in Patients Suffering From Stress Urinary Incontinence
A study testing Autologous adipose tissue harvesting/grafting using Lipogems in people with Urinary Incontinence,Stress, run by The Miriam Hospital at 1 site in United States.
Trial summary
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral sphincter all result in stress incontinence… 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
- Urinary Incontinence,Stress
- What is being tested?
- Autologous adipose tissue harvesting/grafting using Lipogems
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2016to 15 Dec 2018
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients with:
- stress incontinence (SUI)
- mixed urinary incontinence (SUI main component)
- Intrinsic Sphincter Deficiency (ISD)
Who cannot join
- Present diagnosis of cancer (not in remission)
- Patients with uncorrected vaginal prolapse (cystocele or utero/bladder prolapse)
- Incontinence of unknown etiology (other medical reasons) overflow incontinence
- Patients with neurogenic bladder
- Any patients unable to give informed consent, including members of vulnerable populations
- Patients with concomitant pelvic floor disorders, like interstitial cystitis or pelvic floor dysfunction
Show all 9Show fewer
- Vulvar dermatosis, herpes simplex or active or recurrent urinary tract infection
- Patients with chronic steroid use
- Patients 17 and under
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Miriam Hospital/ Women Medicine Collaborative
Providence, Rhode Island, 02904
Janice Santos, MD, 401-421-0710 ext. 1321, janice.santos-cortes@lifespan.org
Patrizia Curran, MD, 401-793-7824, pcurran1@lifespan.org
About this study
Official title: Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral sphincter all result in stress incontinence, urge incontinence and sometimes mixed incontinence respectively.
The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence. This is a prospective study of 25 subjects that will be evaluated over a period of one year.
Read more
The treatment consist of the injection of micro fragmented adipose tissue, previously extracted from the patient in the area of the urethral sphyncter.
Patients will have follow ups at 6 months with Urodynamic studies to measure the pre-post injection differences to-date. Visual analog score questionnaire and report in subjective improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months follow-up.
Read the detailed description
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral sphincter all result in stress incontinence, urge incontinence and sometimes mixed incontinence respectively. The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence. This is a prospective study of 25 subjects that will be evaluated over a period of one year.
Different available treatments for stress urinary incontinence (SUI) are surgical: MMK, R A Z, Burch, (TOT, T VT-mesh sling) and urethral bulking agents. New treatments using mesenchymal stem cells have been tested for the last eight years and now moved from animal models to humans with positive results.
Subjects will receive a full history and examination by a single urologist. A clear history of their incontinence pattern, the amount of incontinence based on PAD counts, under what conditions incontinence occurs to categorize type of incontinence for the female patient pre- or post-menopause. Childbirth history, age of onset, time of occurrence, predisposing factors, medications, hormones, etc. all patients will be registered and categorized according to incontinence.
The patients will receive reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®).
Subjects will log their results immediately post injection and then daily for up to two years noting any changes they've noticed in their presenting problems. At 6 months Urodynamic studies will be performed to measure the pre-post injection differences to-date. Visual analog score questionnaire and report in subjective improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months follow-up.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- Autologous adipose tissue harvesting/grafting using Lipogems
- Keywords
- urinary incontinence, stress urinary incontinence, stress incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose tissue harvesting/grafting using LipogemsProcedure or surgery
Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems
| Study group | Role | What they receive |
|---|---|---|
| Female patients with Stress Incontinence | Experimental | Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck Receives: Procedure: Autologous adipose tissue harvesting/grafting using Lipogems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire
Comparison of pre and post procedure patient reported outcomes questionnaire
Measured: 2 years
Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies
Comparison of pre and post procedure patient Urodynamic studies
Measured: 2 years
Resolution of Stress urinary Incontinence Measured by patient reported pad count
Comparison of pre and post procedure patient pad count
Measured: 2 years
Resolution of Stress urinary Incontinence Measured by patient cough stress test
Comparison of pre and post procedure patient cough stress test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start15 Dec 2016
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janice Santos Cortes, The Miriam Hospital
- Investigators
- Janice Santos, MD, Principal investigator, Women Medicine Collaborative/The Miriam HospitalPatrizia Curran, MD, Study director, The Miriam Hospital/ Women Medicine Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295253
- Sponsor's protocol ID
- 212516
- Status last verified
- Sep 2017
- First submitted
- 2 Aug 2017
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03295253
- Acronym / sponsor ID
- 212516
- Conditions
- Urinary Incontinence,Stress
- Keywords
- urinary incontinence, stress urinary incontinence, stress incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Dec 2018 (estimated)
- First posted
- 27 Sep 2017 (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.
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral sphincter all result in stress incontinence, urge incontinence and sometimes mixed incontinence respectively.
The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence. This is a prospective study of 25 subjects that will be evaluated over a period of one year.
The treatment consist of the injection of micro fragmented adipose tissue, previously extracted from the patient in the area of the urethral sphyncter.
Patients will have follow ups at 6 months with Urodynamic studies to measure the pre-post injection differences to-date. Visual analog score questionnaire and report in subjective improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months follow-up.
Detailed description
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral sphincter all result in stress incontinence, urge incontinence and sometimes mixed incontinence respectively. The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence. This is a prospective study of 25 subjects that will be evaluated over a period of one year.
Different available treatments for stress urinary incontinence (SUI) are surgical: MMK, R A Z, Burch, (TOT, T VT-mesh sling) and urethral bulking agents. New treatments using mesenchymal stem cells have been tested for the last eight years and now moved from animal models to humans with positive results.
Subjects will receive a full history and examination by a single urologist. A clear history of their incontinence pattern, the amount of incontinence based on PAD counts, under what conditions incontinence occurs to categorize type of incontinence for the female patient pre- or post-menopause. Childbirth history, age of onset, time of occurrence, predisposing factors, medications, hormones, etc. all patients will be registered and categorized according to incontinence.
The patients will receive reconstructive lipoplasty with micro-fragmented autologous adipose tissue (Lipogems®).
Subjects will log their results immediately post injection and then daily for up to two years noting any changes they've noticed in their presenting problems. At 6 months Urodynamic studies will be performed to measure the pre-post injection differences to-date. Visual analog score questionnaire and report in subjective improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients with Stress Incontinence | Experimental | Procedure: Autologous adipose tissue harvesting/grafting using LipogemsFemale patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stress incontinence (SUI)
- mixed urinary incontinence (SUI main component)
- Intrinsic Sphincter Deficiency (ISD)
Key exclusion criteria (9 listed)
- Present diagnosis of cancer (not in remission)
- Patients with uncorrected vaginal prolapse (cystocele or utero/bladder prolapse)
- Incontinence of unknown etiology (other medical reasons) overflow incontinence
- Patients with neurogenic bladder
- Any patients unable to give informed consent, including members of vulnerable populations
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 |
|---|---|---|
| Autologous adipose tissue harvesting/grafting using LipogemsAdipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems | Procedure or surgery | Female patients with Stress Incontinence |
Primary outcome
Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire
Time frame: 2 years
Comparison of pre and post procedure patient reported outcomes questionnaire
Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies
Time frame: 2 years
Comparison of pre and post procedure patient Urodynamic studies
Resolution of Stress urinary Incontinence Measured by patient reported pad count
Time frame: 2 years
Comparison of pre and post procedure patient pad count
Resolution of Stress urinary Incontinence Measured by patient cough stress test
Time frame: 2 years
Comparison of pre and post procedure patient cough stress test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- 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. This study is not recruiting at the moment.
Janice Santos, MD principal investigator
Women Medicine Collaborative/The Miriam Hospital
Patrizia Curran, MD study director
The Miriam Hospital/ Women Medicine Collaborative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous adipose tissue harvesting/grafting using Lipogems in people with Urinary Incontinence,Stress, run by The Miriam Hospital 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 4 inclusion and 9 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 27 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janice Santos, MD (401-421-0710 ext. 1321, janice.santos-cortes@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire (time frame: 2 years). The study lists 4 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 27 Sep 2017.