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Trial record 38 of 197 for:    Vaginal Cancer: Clinical Trials

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

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ClinicalTrials.gov Identifier: NCT01444911
Recruitment Status : Terminated (Slow accrual)
First Posted : October 3, 2011
Results First Posted : July 27, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Sexual Dysfunction, Physiological
Interventions Device: Vaginal Renewal Program
Device: Vaginal Dilator
Enrollment 29
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Vaginal Renewal Program Standard of Care
Hide Arm/Group Description 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.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Period Title: Overall Study
Started 16 13
Completed 8 13
Not Completed 8 0
Arm/Group Title Vaginal Renewal Program Standard of Care Total
Hide Arm/Group Description 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.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Total of all reporting groups
Overall Number of Baseline Participants 16 13 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  93.8%
11
  84.6%
26
  89.7%
>=65 years
1
   6.3%
2
  15.4%
3
  10.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Female
16
 100.0%
13
 100.0%
29
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 13 participants 29 participants
16 13 29
Pelvic Radiation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Prior Pelvic Radiation 2 1 3
No Prior Pelvic Radiation 14 12 26
Primary Disease Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Ovary 5 5 10
Endometrium 6 6 12
Cervix 3 1 4
Vulva 1 0 1
Dual Primary (Ovary and Endometrium) 1 1 2
1.Primary Outcome
Title Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
Hide Description 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.
Time Frame At baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaginal Renewal Program Standard of Care
Hide Arm/Group Description:
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.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Overall Number of Participants Analyzed 8 13
Mean (Full Range)
Unit of Measure: Units on a scale
5.575
(-8.4 to 14)
6.069
(-4.0 to 20.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaginal Renewal Program, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Marinoff Scale at 6 Months
Hide Description

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.

Time Frame At baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vaginal Renewal Program Standard of Care
Hide Arm/Group Description:
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.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Overall Number of Participants Analyzed 7 11
Mean (Full Range)
Unit of Measure: units on a scale
-0.857
(-2 to 0)
-0.818
(-3 to 0)
3.Secondary Outcome
Title FACT-G Score
Hide Description 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.
Time Frame At baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaginal Renewal Program Standard of Care
Hide Arm/Group Description:
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.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Overall Number of Participants Analyzed 8 13
Mean (Full Range)
Unit of Measure: units on a scale
4.375
(-15 to 22)
4.872
(-1 to 25)
4.Secondary Outcome
Title Vaginal Length
Hide Description Change in vaginal length as measured from baseline to 6 months.
Time Frame At baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaginal Renewal Program Standard of Care
Hide Arm/Group Description:
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.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

Overall Number of Participants Analyzed 8 13
Mean (Full Range)
Unit of Measure: Centimeters
1.188
(0 to 3.5)
0.154
(-3 to 1)
Time Frame Adverse event data were collected for 1 year, 8 months.
Adverse Event Reporting Description 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.
 
Arm/Group Title Vaginal Renewal Program Standard of Care
Hide Arm/Group Description 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.

This will consist of still vaginal dilator and/or lubricant.

Vaginal Dilator: Still vaginal dilator with lubricant.

All-Cause Mortality
Vaginal Renewal Program Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vaginal Renewal Program Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vaginal Renewal Program Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/16 (25.00%)      3/13 (23.08%)    
Infections and infestations     
Urinary tract infections (UTI)  1  1/16 (6.25%)  1 2/13 (15.38%)  3
Musculoskeletal and connective tissue disorders     
Wrist pain  1  0/16 (0.00%)  1/13 (7.69%)  1
Renal and urinary disorders     
Bladder irritation  1  1/16 (6.25%)  1 0/13 (0.00%) 
Bladder pressure  1  1/16 (6.25%)  1 0/13 (0.00%) 
Reproductive system and breast disorders     
Vaginal infection  1 [1]  1/16 (6.25%)  1 0/13 (0.00%) 
Vaginal irritation  1  1/16 (6.25%)  1 0/13 (0.00%) 
Vulvar fissures  1  1/16 (6.25%)  1 0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Yeast
The study was closed before completion due to a slowing accrual rate.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David Kushner
Organization: University of Wisconsin Carbone Cancer Center
Phone: 608-263-1210
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01444911     History of Changes
Other Study ID Numbers: 2011-0217
OS10706 ( Other Identifier: UWCCC )
First Submitted: September 29, 2011
First Posted: October 3, 2011
Results First Submitted: January 24, 2017
Results First Posted: July 27, 2017
Last Update Posted: August 25, 2017