Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OS10706 | Other Identifier | University of Wisconsin Carbone Cancer Center | |
| NCI-2011-03674 | Registry Identifier | NCI Trial ID | |
| A532820 | Other Identifier | UW Madison | |
| SMPH\OBSTET & GYNEC\GYNEC ONC | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Slow accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewalâ„¢ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers.
In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP).
Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Renewal Program | Experimental |
| |
| Standard of care | Active Comparator | This will consist of still vaginal dilator and/or lubricant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Renewal Program | Device | The Vaginal Renewalâ„¢ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months | Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. | At baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Marinoff Scale at 6 Months | The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse
Difference in Marinoff scores reported, value at 6 months minus value at baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David M Kushner, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States | Madison | Wisconsin | 53792 | United States |
Not provided
| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
Not provided
Not provided
Participants with a history of a gynecologic cancer and self-reported sexual dysfunction that was new or worsened since cancer diagnosis, and were randomized to one of two arms. All participants enrolled at the Gynecologic Oncology and Radiation Oncology clinics at the University of Wisconsin Carbone Cancer Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vaginal Renewal Program | Vaginal Renewal Program: The Vaginal Renewalâ„¢ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant. |
| FG001 | Standard of Care | This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vaginal Renewal Program | Vaginal Renewal Program: The Vaginal Renewalâ„¢ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months | Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. | Posted | Mean | Full Range | Units on a scale | At baseline and 6 months |
|
Adverse event data were collected for 1 year, 8 months.
Participants were assessed for toxicity at each study visit. All events at least possibly related to the study intervention will be collected. Participants were instructed to call the study team for adverse events that occurred between visits. The study team or an on-call physician were available 24 hours a day.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaginal Renewal Program | Vaginal Renewal Program: The Vaginal Renewalâ„¢ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder irritation | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
The study was closed before completion due to a slowing accrual rate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Kushner | University of Wisconsin Carbone Cancer Center | 608-263-1210 | dmkushner@facstaff.wisc.edu |
Not provided
| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vaginal Dilator | Device | Still vaginal dilator with lubricant. |
|
| At baseline and 6 months |
| FACT-G Score | The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported. | At baseline and 6 months |
| Vaginal Length | Change in vaginal length as measured from baseline to 6 months. | At baseline and 6 months |
This will consist of still vaginal dilator and/or lubricant.
Vaginal Dilator: Still vaginal dilator with lubricant.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pelvic Radiation | Number | participants |
|
| Primary Disease Site | Number | participants |
|
|
|
|
| Secondary | Change in Marinoff Scale at 6 Months | The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse
Difference in Marinoff scores reported, value at 6 months minus value at baseline. | Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated. | Posted | Mean | Full Range | units on a scale | At baseline and 6 months |
|
|
|
| Secondary | FACT-G Score | The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported. | Posted | Mean | Full Range | units on a scale | At baseline and 6 months |
|
|
|
| Secondary | Vaginal Length | Change in vaginal length as measured from baseline to 6 months. | Posted | Mean | Full Range | Centimeters | At baseline and 6 months |
|
|
|
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | Standard of Care | This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant. | 0 | 13 | 3 | 13 |
| Bladder pressure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infections (UTI) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal infection | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Yeast |
|
| Vaginal irritation | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar fissures | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wrist pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided