Lower Urinary Tract SymptomsNCT07175805
Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy
An observational study of Lower Urinary Tract Symptoms and Stress Urinary Incontinence, run by Hartford HealthCare at 1 site in United States.
Trial summary
The purpose of this study is to compare change in pelvic floor symptoms between patients receiving medical therapy for weight loss and surgical treatment for weight loss. Examples of pelvic floor symptoms include urinary incontinence, urinary urgency, urinary frequency, fecal incontinence, and vaginal prolapse. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Urge Urinary Incontinence
- What is being tested?
- Bariatric Surgery and GLP1 receptor agonist
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Jun 2027
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seeking medical weight loss or surgical weight loss at the weight loss clinics at Hartford Hospital.
Who may be able to join
- female
- 18-89 years old
- any race/ethnicity
- BMI ≥30 kg/m2
- current medical weight loss or surgical weight loss patient of Obesity Medicine and Metabolic \& Bariatric Surgery
- able/willing to give informed consent
Show all 13Show fewer
- have a home scale to measure weight
- Patients meeting all the following criteria will be eligible to participate in the medical weight loss therapy arm:
- prescribed and start a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or a GLP-1/gastric inhibitory peptide (GIP1)
- taking other weight loss agents (such as metformin)
- Patients meeting all the following criteria will be eligible to participate in the bariatric surgery arm:
- plan to undergo gastric sleeve or gastric bypass surgery
- taking weight loss agents which are not GLP-1 RA or GLP-1/GIP1 medications at the start of the study. Patients will not be excluded if they are started on GLP-1 RA or GLP-1/GIP1 medications after surgery.
Who cannot join
- Pregnant
- ≥90 years old
- <18 years old
- BMI <30 kg/m2
- A history of bariatric surgery prior to enrollment
- No home scale to measure weight
- Active cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hartford Hospital
Hartford, Connecticut, 06106
Madeline Carmain, MD, 860-972-4338, madeline.carmain@hcchealth.org
About this study
The purpose of this study is to compare change in pelvic floor symptoms between patients receiving medical therapy for weight loss and surgical treatment for weight loss. Examples of pelvic floor symptoms include urinary incontinence, urinary urgency, urinary frequency, fecal incontinence, and vaginal prolapse. Participants in this study do not need to have any pelvic floor symptoms to enroll in the study. Understanding how different types of weight loss treatment impact pelvic floor symptoms will help clinicians guide which weight loss treatments are recommended for patients with pelvic floor symptoms in the future.
Read the detailed description
Lower Urinary Tract Symptoms (LUTS) are defined as bothersome symptoms related to the storage of urine, voiding, and postvoid symptoms, and includes urgency, frequency, and urinary incontinence (UI). UI is the involuntary loss of urine and is a common and bothersome form of LUTS. The prevalence of urinary incontinence is high and increasing, with 61.8% of all women over 20 years old reporting urinary incontinence. High body mass index (BMI) is associated with higher risk of UI. In women with UI, modest weight loss due to behavioral changes or dieting has been shown to decrease the frequency of UI episodes. In women with UI who lost weight through bariatric surgery, there is improvement or even complete resolution of UI symptoms. Within the field of weight loss management, bariatric surgery is seen as the gold standard treatment with well-established improvements in LUTS symptoms.
UI is known to impact quality of life, with worse UI symptoms correlated with worse quality of life scores. Treatment resulting in improved or resolution of UI symptoms improves quality of life scores. In addition, UI takes a financial toll on women, with estimates from 2008 showing that patients spend $1500 annually for incontinence products. Any treatment which is able to improve or resolve symptoms of UI has the potential to significantly improve patient's quality of life and decrease patient's financial burdens.
In addition to LUTS symptoms, there are other pelvic disorders which are influenced by obesity and pelvic muscle function. Pelvic organ prolapse (POP), the descent of intrabdominal organs (bladder, rectum, intestines, uterus) into the vaginal space, is more common in overweight and obese women; a metanalysis of women with POP who underwent bariatric surgery had improvement in POP symptoms after surgery. Fecal incontinence (FI) is the involuntary loss of stool; the rate of FI is higher in patients with obesity. The causal relationship between weight loss and FI improvement is not clear (as FI is highly dependent on stool consistency), although there are studies which demonstrate improvement of FI after bariatric surgery. All of these disorders can be treated or improved with pelvic floor physical therapy, illustrating the importance of pelvic floor musculature in appropriate function of pelvic organs and function. A weight loss therapy which potentially diminishes the function of the pelvic floor through lean muscle loss may worsen any of these pelvic floor associated disorders.
In 2021, semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), was approved by the FDA for weight management. Since this approval, there has been a rapid uptake of these medications for weight loss, with 1 in 12 people in the United States having been prescribed a GLP-1 RA as of May 2024. A recent study showed that GLP-1 RA prescriptions for people who were overweight or obese but did not have diabetes increased 700% between 2019 and 2023. With the rapid uptake of these drugs for weight loss, there has been significant interest in understanding the full beneficial effects of treatment for patients taking GLP-1 RA for weight loss, with recent studies demonstrating cardiovascular benefits for overweight patients being treated with GLP-1 RAs. A second class of related medications, dual GLP-1 RA and gastric inhibitory peptide-1 (GIP1) medications have been released and are being used for weight loss management. At this time, there are no studies published investigating the effect of weight loss with GLP-1 RAs or GLP-1/GIP1s on LUTS.
Given the rapid uptake of this therapy class for weight loss, it is necessary to establish whether weight loss from GLP-1 RAs results in the same improvement in LUTS as other therapies. Recent investigations show that there can be a high amount of lean body mass and muscle loss as a component of the weight lost with GLP-1 RA therapy; recent studies demonstrate that 30% of weight lost using GLP-1 RAs was secondary to loss of lean muscle mass. As the pelvic floor musculature is essential in preventing LUTS symptoms, GLP-1 RA therapy may worsen LUTS. At this time, it is not clear that weight lost with GLP-1 RAs will result in the same improvement of LUTS symptoms as weight lost with behavioral changes, dietary changes, or bariatric surgery.
In this study, the investigators will evaluate the difference of LUTS, UI, FI, and POP symptoms between patients losing weight through bariatric surgery or GLP-1/GIP1 therapy. By comparing results of weight loss from GLP-1 RAs or combination GLP-1/GIP1 medications to weight loss from bariatric surgery, the gold standard weight loss treatment that is well established to improve LUTS and POP symptoms, the investigators will be able to detect whether there are differences in improvement in these pelvic floor disorders based on the mechanism of weight loss or whether it is only the amount of weight lost that impacts symptomatic improvement.
- Conditions
- Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Urge Urinary Incontinence, Overactive Bladder, Pelvic Organ Prolapse, Weight Loss
- Being tested
- Bariatric Surgery, GLP1 receptor agonist
- Keywords
- lower urinary tract symtpoms, stress urinary incontinence, urge urinary incontinence, overactive bladder, pelvic organ prolapse, weight loss, fecal incontinence, bariatric surgery, glp1 agonist
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Bladder, Overactive, Pelvic Organ Prolapse, Weight Loss, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
Patients in this arm plan to undergo gastric sleeve or gastric bypass surgery.
GLP1 receptor agonistDrug
Patients in this arm plan to start a GLP-1 receptor agonist.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Patients who plan to undergo bariatric surgery Receives: Procedure: Bariatric Surgery | |
| GLP1 or GLP1/GIP1 | Patients who plan to take GLP1 or GLP1/GIP1 medications Receives: Drug: GLP1 receptor agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pelvic floor symptoms measured by survey the Urogenital Distress Inventory (UDI)
The investigators plan to measure the change in pelvic floor symptoms between woman taking glucagon-like peptide-1 receptor agonists (GLP1) medications vs women receiving bariatric surgery. These changes will be measured by validated survey, including the Urogenital Distress Inventory (UDI)
Measured: 6 months
Change in pelvic floor symptoms measured by validated survey the Colorectal-Anal Distress Inventory (CRADI-8).
The investigators plan to measure the change in pelvic floor symptoms between woman taking glucagon-like peptide-1 receptor agonists (GLP1) medications vs women receiving bariatric surgery. These changes will be measured by validated survey the Colorectal-Anal Distress Inventory (CRADI-8).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (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 Lower Urinary Tract SymptomsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madeline Carmain, Hartford HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175805
- Sponsor's protocol ID
- HHC-2025-0168
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chirumamilla V, Tyler KH. Menopause, Weight Loss, and Pelvic Floor Changes: Clinical and Aesthetic Considerations. Dermatol Surg. 2026 Nov 3. doi: 10.1097/DSS.0000000000005435. Online ahead of print.
PubMed 42975544
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy
- ClinicalTrials.gov ID
- NCT07175805
- Acronym / sponsor ID
- HHC-2025-0168
- Conditions
- Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Urge Urinary Incontinence, Overactive Bladder, Pelvic Organ Prolapse, Weight Loss
- Keywords
- lower urinary tract symtpoms, stress urinary incontinence, urge urinary incontinence, overactive bladder, pelvic organ prolapse, weight loss, fecal incontinence, bariatric surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hartford HealthCareUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Sep 2025 (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.
The purpose of this study is to compare change in pelvic floor symptoms between patients receiving medical therapy for weight loss and surgical treatment for weight loss. Examples of pelvic floor symptoms include urinary incontinence, urinary urgency, urinary frequency, fecal incontinence, and vaginal prolapse. Participants in this study do not need to have any pelvic floor symptoms to enroll in the study. Understanding how different types of weight loss treatment impact pelvic floor symptoms will help clinicians guide which weight loss treatments are recommended for patients with pelvic floor symptoms in the future.
Detailed description
Lower Urinary Tract Symptoms (LUTS) are defined as bothersome symptoms related to the storage of urine, voiding, and postvoid symptoms, and includes urgency, frequency, and urinary incontinence (UI). UI is the involuntary loss of urine and is a common and bothersome form of LUTS. The prevalence of urinary incontinence is high and increasing, with 61.8% of all women over 20 years old reporting urinary incontinence. High body mass index (BMI) is associated with higher risk of UI. In women with UI, modest weight loss due to behavioral changes or dieting has been shown to decrease the frequency of UI episodes. In women with UI who lost weight through bariatric surgery, there is improvement or even complete resolution of UI symptoms. Within the field of weight loss management, bariatric surgery is seen as the gold standard treatment with well-established improvements in LUTS symptoms.
UI is known to impact quality of life, with worse UI symptoms correlated with worse quality of life scores. Treatment resulting in improved or resolution of UI symptoms improves quality of life scores. In addition, UI takes a financial toll on women, with estimates from 2008 showing that patients spend $1500 annually for incontinence products. Any treatment which is able to improve or resolve symptoms of UI has the potential to significantly improve patient's quality of life and decrease patient's financial burdens.
In addition to LUTS symptoms, there are other pelvic disorders which are influenced by obesity and pelvic muscle function. Pelvic organ prolapse (POP), the descent of intrabdominal organs (bladder, rectum, intestines, uterus) into the vaginal space, is more common in overweight and obese women; a metanalysis of women with POP who underwent bariatric surgery had improvement in POP symptoms after surgery. Fecal incontinence (FI) is the involuntary loss of stool; the rate of FI is higher in patients with obesity. The causal relationship between weight loss and FI improvement is not clear (as FI is highly dependent on stool consistency), although there are studies which demonstrate improvement of FI after bariatric surgery. All of these disorders can be treated or improved with pelvic floor physical therapy, illustrating the importance of pelvic floor musculature in appropriate function of pelvic organs and function. A weight loss therapy which potentially diminishes the function of the pelvic floor through lean muscle loss may worsen any of these pelvic floor associated disorders.
In 2021, semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), was approved by the FDA for weight management. Since this approval, there has been a rapid uptake of these medications for weight loss, with 1 in 12 people in the United States having been prescribed a GLP-1 RA as of May 2024. A recent study showed that GLP-1 RA prescriptions for people who were overweight or obese but did not have diabetes increased 700% between 2019 and 2023. With the rapid uptake of these drugs for weight loss, there has been significant interest in understanding the full beneficial effects of treatment for patients taking GLP-1 RA for weight loss, with recent studies demonstrating cardiovascular benefits for overweight patients being treated with GLP-1 RAs. A second class of related medications, dual GLP-1 RA and gastric inhibitory peptide-1 (GIP1) medications have been released and are being used for weight loss management. At this time, there are no studies published investigating the effect of weight loss with GLP-1 RAs or GLP-1/GIP1s on LUTS.
Given the rapid uptake of this therapy class for weight loss, it is necessary to establish whether weight loss from GLP-1 RAs results in the same improvement in LUTS as other therapies. Recent investigations show that there can be a high amount of lean body mass and muscle loss as a component of the weight lost with GLP-1 RA therapy; recent studies demonstrate that 30% of weight lost using GLP-1 RAs was secondary to loss of lean muscle mass. As the pelvic floor musculature is essential in preventing LUTS symptoms, GLP-1 RA therapy may worsen LUTS. At this time, it is not clear that weight lost with GLP-1 RAs will result in the same improvement of LUTS symptoms as weight lost with behavioral changes, dietary changes, or bariatric surgery.
In this study, the investigators will evaluate the difference of LUTS, UI, FI, and POP symptoms between patients losing weight through bariatric surgery or GLP-1/GIP1 therapy. By comparing results of weight loss from GLP-1 RAs or combination GLP-1/GIP1 medications to weight loss from bariatric surgery, the gold standard weight loss treatment that is well established to improve LUTS and POP symptoms, the investigators will be able to detect whether there are differences in improvement in these pelvic floor disorders based on the mechanism of weight loss or whether it is only the amount of weight lost that impacts symptomatic improvement.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | – | Procedure: Bariatric SurgeryPatients who plan to undergo bariatric surgery |
| GLP1 or GLP1/GIP1 | – | Drug: GLP1 receptor agonistPatients who plan to take GLP1 or GLP1/GIP1 medications |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking medical weight loss or surgical weight loss at the weight loss clinics at Hartford Hospital.
Key inclusion criteria (13 listed)
- female
- 18-89 years old
- any race/ethnicity
- BMI ≥30 kg/m2
- current medical weight loss or surgical weight loss patient of Obesity Medicine and Metabolic \& Bariatric Surgery
Key exclusion criteria (7 listed)
- Pregnant
- ≥90 years old
- <18 years old
- BMI <30 kg/m2
- A history of bariatric surgery prior to enrollment
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 |
|---|---|---|
| Bariatric SurgeryPatients in this arm plan to undergo gastric sleeve or gastric bypass surgery. | Procedure or surgery | Bariatric Surgery |
| GLP1 receptor agonistPatients in this arm plan to start a GLP-1 receptor agonist. | Drug | GLP1 or GLP1/GIP1 |
Primary outcome
Change in pelvic floor symptoms measured by survey the Urogenital Distress Inventory (UDI)
Time frame: 6 months
The investigators plan to measure the change in pelvic floor symptoms between woman taking glucagon-like peptide-1 receptor agonists (GLP1) medications vs women receiving bariatric surgery. These changes will be measured by validated survey, including the Urogenital Distress Inventory (UDI)
Change in pelvic floor symptoms measured by validated survey the Colorectal-Anal Distress Inventory (CRADI-8).
Time frame: 6 months
The investigators plan to measure the change in pelvic floor symptoms between woman taking glucagon-like peptide-1 receptor agonists (GLP1) medications vs women receiving bariatric surgery. These changes will be measured by validated survey the Colorectal-Anal Distress Inventory (CRADI-8).
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 16 Sep 2025.
- Derived from this study: PubMed 42975544Chirumamilla V, Tyler KH. Menopause, Weight Loss, and Pelvic Floor Changes: Clinical and Aesthetic Considerations. Dermatol Surg. 2026 Nov 3. doi: 10.1097/DSS.0000000000005435. Online ahead of print.
- 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.
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 Lower Urinary Tract Symptoms and Stress Urinary Incontinence, run by Hartford HealthCare 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 13 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 Sep 2025. 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?
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 Madeline Carmain, MD (860.972.4338, madeline.carmain@hcchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic floor symptoms measured by survey the Urogenital Distress Inventory (UDI) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT07175805, 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 16 Sep 2025.