Trial Outcomes & Findings for Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction (NCT NCT01444911)

Last Updated: 2019-12-09

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

At baseline and 6 months

Results posted on

2019-12-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Vaginal Renewal Program Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.	Standard of Care This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
Overall Study STARTED	16	13
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	8	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaginal Renewal Program n=16 Participants Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.	Standard of Care n=13 Participants This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Pelvic Radiation Prior Pelvic Radiation	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Pelvic Radiation No Prior Pelvic Radiation	14 participants n=5 Participants	12 participants n=7 Participants	26 participants n=5 Participants
Primary Disease Site Ovary	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Primary Disease Site Endometrium	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Primary Disease Site Cervix	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Primary Disease Site Vulva	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Primary Disease Site Dual Primary (Ovary and Endometrium)	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline and 6 months

Outcome measures

Outcome measures
Measure	Vaginal Renewal Program n=8 Participants Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.	Standard of Care n=13 Participants This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months	5.575 Units on a scale Interval -8.4 to 14.0	6.069 Units on a scale Interval -4.0 to 20.8

SECONDARY outcome

Timeframe: At baseline and 6 months

Population: 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.

The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse 1. = pain with intercourse that doesn't prevent the completion 2. = pain with intercourse requiring interruption or discontinuance 3. = pain with intercourse preventing any intercourse Difference in Marinoff scores reported, value at 6 months minus value at baseline.

Outcome measures

Outcome measures
Measure	Vaginal Renewal Program n=7 Participants Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.	Standard of Care n=11 Participants This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
Change in Marinoff Scale at 6 Months	-0.857 units on a scale Interval -2.0 to 0.0	-0.818 units on a scale Interval -3.0 to 0.0

SECONDARY outcome

Timeframe: At baseline and 6 months

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.

Outcome measures

Outcome measures
Measure	Vaginal Renewal Program n=8 Participants Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.	Standard of Care n=13 Participants This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
FACT-G Score	4.375 units on a scale Interval -15.0 to 22.0	4.872 units on a scale Interval -1.0 to 25.0

SECONDARY outcome

Timeframe: At baseline and 6 months

Change in vaginal length as measured from baseline to 6 months.

Outcome measures

Outcome measures
Measure	Vaginal Renewal Program n=8 Participants Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.	Standard of Care n=13 Participants This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
Vaginal Length	1.188 Centimeters Interval 0.0 to 3.5	0.154 Centimeters Interval -3.0 to 1.0

Adverse Events

Vaginal Renewal Program

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vaginal Renewal Program n=16 participants at risk Vaginal Renewal Program: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.	Standard of Care n=13 participants at risk This will consist of still vaginal dilator and/or lubricant. Vaginal Dilator: Still vaginal dilator with lubricant.
Renal and urinary disorders Bladder irritation	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/13 • 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.
Renal and urinary disorders Bladder pressure	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/13 • 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.
Infections and infestations Urinary tract infections (UTI)	6.2% 1/16 • Number of events 1 • 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.	15.4% 2/13 • Number of events 3 • 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.
Reproductive system and breast disorders Vaginal infection	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/13 • 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.
Reproductive system and breast disorders Vaginal irritation	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/13 • 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.
Reproductive system and breast disorders Vulvar fissures	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/13 • 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.
Musculoskeletal and connective tissue disorders Wrist pain	0.00% 0/16 • 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.	7.7% 1/13 • Number of events 1 • 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.

Additional Information

Dr. David Kushner

University of Wisconsin Carbone Cancer Center

Phone: 608-263-1210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place