Bladder CarcinomaNCT05399004
Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
An observational study of Bladder Carcinoma, run by Mayo Clinic at 14 sites in United States.
Trial summary
This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bladder Carcinoma
- What is being tested?
- Survey Administration
- How many people
- 34 participants
- Where
- 14 sitesUnited States
- Study dates
- 3 Sep 2019to 30 Jun 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients undergoing radical cystectomy for bladder cancer between September 1, 2019 and December 31, 2022.
Who may be able to join
- Adult women greater than 18 years of age
- A diagnosis of bladder cancer
- Planned to undergo a radical cystectomy
- Willing and able to complete survey questionnaires
Who cannot join
- Inability to provide informed consent
- Non-English speaking
- Life expectancy less than 2 years
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
M D Anderson Cancer Center
Houston, Texas, 77030
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Louisiana State University
Lafayette, Louisiana, 70503
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: Sexual Function in Women After Radical Cystectomy
This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. This may affect sexual function in women. This study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.
Read the detailed description
PRIMARY OBJECTIVES:
- To characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.
II. To identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy.
III. To describe pre-operative importance in sexual function recovery after radical cystectomy.
IV. Quantify the changes in sexual function within the year following radical cystectomy in women.
- Explore the effects of age, baseline sexual function, general quality of life, parity, menopausal status, hormone replacement therapy (topical versus [vs.] oral), general and cancer related quality of life, chemotherapy (neoadjuvant vs. adjuvant), treatment-related complications and performance status on sexual function outcomes.
VI. Explore the effects of robotic vs. open approach, extracorporeal vs. intracorporal approach, organ-sparing (ovaries, uterus, cervix, anterior vaginal wall), type of vaginal closure (vertical vs. horizontal), nerve sparing, urinary diversion type (ileal conduit vs. neobladder vs. continent cutaneous diversion) on sexual function outcomes.
VII. Quantify the changes in sexual activity interest within the year following radical cystectomy.
OUTLINE:
Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.
- Conditions
- Bladder Carcinoma
- Being tested
- Survey Administration
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey) | Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative sexual function
Assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction version 2 (v2.0). Will utilize descriptive statistics to report preoperative sexual function. Frequencies and percentages will be reported for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables.
Measured: Baseline
Interest in sexual activity
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Lubrication
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Vaginal discomfort
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Satisfaction with sex life
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Secondary outcomes (5)
Labial discomfort
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Clitoral discomfort
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Orgasm ability
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Orgasm pleasure
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Measured: From baseline to 3, 6, and 12 months
Change in sexual function scores
Will use a linear mixed effects model of 12-month sexual function scores adjusting for baseline function to evaluate independent variables of interest related to the surgical procedure: age, robotic/open approach, pelvic organ sparing and diversion type. Variables of interest will be analyzed separately. In the analysis of robotic vs. open approach, the model will include terms for time (after surgery: 3, 6, and 12 months, using a discrete time formulation), approach (robotic=1, open=0), and approach by time interaction. Contrasts of the interaction and main effects will allow estimation of whether outcomes at 12 months differ by approach.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start3 Sep 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen A. Boorjian, M.D., Mayo Clinic
- Investigators
- Stephen A Boorjian, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399004
- Sponsor's protocol ID
- 19-007376
- Other IDs
- NCI-2021-13603
- Status last verified
- Aug 2024
- First submitted
- 26 May 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Function in Women After Radical Cystectomy
- ClinicalTrials.gov ID
- NCT05399004
- Acronym / sponsor ID
- 19-007376
- Conditions
- Bladder Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 Jun 2022 (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.
This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. This may affect sexual function in women. This study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.
Detailed description
PRIMARY OBJECTIVES:
- To characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.
II. To identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy.
III. To describe pre-operative importance in sexual function recovery after radical cystectomy.
IV. Quantify the changes in sexual function within the year following radical cystectomy in women.
- Explore the effects of age, baseline sexual function, general quality of life, parity, menopausal status, hormone replacement therapy (topical versus [vs.] oral), general and cancer related quality of life, chemotherapy (neoadjuvant vs. adjuvant), treatment-related complications and performance status on sexual function outcomes.
VI. Explore the effects of robotic vs. open approach, extracorporeal vs. intracorporal approach, organ-sparing (ovaries, uterus, cervix, anterior vaginal wall), type of vaginal closure (vertical vs. horizontal), nerve sparing, urinary diversion type (ileal conduit vs. neobladder vs. continent cutaneous diversion) on sexual function outcomes.
VII. Quantify the changes in sexual activity interest within the year following radical cystectomy.
OUTLINE:
Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey) | – | Other: Survey AdministrationPatients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients undergoing radical cystectomy for bladder cancer between September 1, 2019 and December 31, 2022.
Key inclusion criteria (4 listed)
- Adult women greater than 18 years of age
- A diagnosis of bladder cancer
- Planned to undergo a radical cystectomy
- Willing and able to complete survey questionnaires
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Non-English speaking
- Life expectancy less than 2 years
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 |
|---|---|---|
| Survey AdministrationComplete surveys | Other | Observational (survey) |
Primary outcome
Preoperative sexual function
Time frame: Baseline
Assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction version 2 (v2.0). Will utilize descriptive statistics to report preoperative sexual function. Frequencies and percentages will be reported for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables.
Interest in sexual activity
Time frame: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Lubrication
Time frame: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Vaginal discomfort
Time frame: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
Satisfaction with sex life
Time frame: From baseline to 3, 6, and 12 months
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.
5 secondary outcomes
Labial discomfort
Time frame: From baseline to 3, 6, and 12 months
Clitoral discomfort
Time frame: From baseline to 3, 6, and 12 months
Orgasm ability
Time frame: From baseline to 3, 6, and 12 months
Orgasm pleasure
Time frame: From baseline to 3, 6, and 12 months
Change in sexual function scores
Time frame: From baseline to 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 4 Sep 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Stephen A Boorjian principal investigator
Mayo Clinic in Rochester
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Carcinoma, run by Mayo Clinic at 14 sites 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 3 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Preoperative sexual function (time frame: Baseline). 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?
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 4 Sep 2024.