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Endometrial CancerCUTINCT02667431

Cancer of the Uterus and Treatment of Stress Urinary Incontinence

An observational study of Endometrial Cancer and Stress Urinary Incontinence, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical health and decrease costs for both patients and the health care system. At the time of endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a gynecologic oncologist, but the majority will undergo… Read more about this study

Who is it for?
Ages 18 to 100 years, women only
How many people
556 participants
Where
1 siteUnited States
Study dates
Jan 2016to Apr 2019
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 18 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with newly diagnosed complex atypical hyperplasia or clinical stage 1 or 2 endometrial cancer based on physical exam and/or imaging will be approached.

Who may be able to join

  • Women will be eligible if they have:
  • clinical stage 1 or 2 (disease confined to the uterus) endometrial carcinoma or complex atypical hyperplasia
  • answer yes to one screening question: "Do you ever leak urine when you cough, sneeze, jump or laugh?" We will include women with complex atypical hyperplasia (CAH) because 40% of these women will have an endometrial cancer identified at the time of surgery and the risk factors are the same for CAH as they are for clinical stage 1 and 2 endometrial cancers

Who cannot join

  • Women will be excluded if they have
  • clinical stage 3 and 4 endometrial cancer
  • prior pelvic radiation therapy
  • vesicovaginal fistula
  • urethrovaginal fistula.
  • We are excluding women with vesicovaginal fistula or urethrovaginal fistula due to the risk of infection when placing a midurethral sling.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical health and decrease costs for both patients and the health care system. At the time of endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a gynecologic oncologist, but the majority will undergo surgery within weeks of their diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and concurrent surgery performed. This would spare the patient two surgeries, decrease the emotional distress associated with SUI symptoms, decrease the costs associated with SUI for the patient and possibly improve overall quality of life. The proposed study will compare the quality of life and clinical outcomes among women with endometrial cancer and SUI that have concurrent surgery to women that do not have concurrent surgery. The findings of our proposed research will provide valuable information necessary for woman and clinicians to make decisions regarding the treatment of SUI, including evidence regarding the risks and benefits of performing concurrent endometrial cancer and SUI surgery.

Keywords
SUI
Medical subject headings
Endometrial Neoplasms, Urinary Incontinence, Stress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

    The purpose of this study is to compare quality of life among women with endometrial cancer and SUI who undergo SUI and endometrial cancer surgery simultaneously to women that do not.

    Measured: Pre-op to 12 month post-op

  2. Sexual Function will be measured using the female sexual function index (FSFI)

    Compare the sexual function of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only. Sexual function will be measured using the female sexual function index (FSFI). It is a 19-item instrument assessing 6 domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain.

    Measured: Pre-op to 12 month post-op

  3. Clinical Outcomes- Time to Surgery

    Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only, by measuring time to surgery (ie: number of days) using hospital records. The estimated time to surgery will be assessed up to 12 weeks, measuring from initial date of enrollment to date of documented surgery date.

    Measured: Enrollment to Day of Surgery

  4. Clinical Outcomes- Surgical Outcomes

    Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only by examining surgical outcomes such as intra op injuries or complications using hospital records.

    Measured: Pre-op to 12 month post-op

  5. Clinical Outcomes- Post-Operative Complications

    Compare the clinical outcomes of women with endometrial cancer and SUI who have concurrent surgery to women who have cancer surgery only by examining Post-Operative complications. We will document any treatment-related adverse events as assessed by CTCAE v4.0. We will use hospital records.

    Measured: Pre-op to 12 month post-op

Secondary outcomes (2)

  1. Sling Complications

    Compare the rate of midurethral sling complications among women who received radiation after sling placement to women who did not receive radiation using hospital records.

    Measured: Pre-op to 12 month post-op

  2. Post- Operative Pain

    We will also measure post-operative pain, using the modified Brief Pain Inventory (BPI) scale.

    Measured: Day 1 in hospital after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionApr 2019 (estimated)
  4. Study completionApr 2019 (estimated)

Resources

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
556 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02667431
Sponsor's protocol ID
823303-1
Acronym
CUTI
Status last verified
Oct 2018
First submitted
2 Dec 2015
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Robison K, Wohlrab K, Howe CJ, Richter HE, Sung V, Bevis KS, Luis C, McCourt C, Lowder J, Occhino J, Glaser G, Lokich E, Dunivan G, Brown A, Tunitsky-Bitton E, Wethington S, Chen CCG, Rahn D, Carlson M, Cram R, Raker C, Clark MA. Endometrial Cancer Surgery With or Without Concomitant Stress Urinary Incontinence Surgery. Obstet Gynecol. 2023 Apr 1;141(4):642-652. doi: 10.1097/AOG.0000000000005059. Epub 2023 Mar 9.

    PubMed 36897162

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Cancer and Stress Urinary Incontinence, run by Women and Infants Hospital of Rhode Island 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 6 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 2 Oct 2018. 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?

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?

Quality of Life (time frame: Pre-op to 12 month post-op). 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?

On the ClinicalTrials.gov record for NCT02667431, 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 2 Oct 2018.

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