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Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen (IMPROVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02431897
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : December 16, 2022
Last Update Posted : September 6, 2023
Sponsor:
Collaborators:
University of Alabama at Birmingham
Women and Infants Hospital of Rhode Island
Pfizer
Information provided by (Responsible Party):
David Rahn, MD, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pelvic Organ Prolapse
Urogenital Prolapse
Vaginal Vault Prolapse
Cystocele
Uterine Prolapse
Vaginal Prolapse
Pelvic Floor Disorders
Interventions Drug: Conjugated Estrogens Cream
Drug: Placebo Cream
Enrollment 206
Recruitment Details  
Pre-assignment Details Of the 206 participants consented/enrolled, 7 were not randomized: 4 withdrew consent before randomization, and 3 were found to be ineligible and were not randomized. This left n=199 for randomization.
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery. Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Period Title: Overall Study
Started 102 97
Completed 93 93
Not Completed 9 4
Arm/Group Title Estrogen Cream Placebo Cream Total
Hide Arm/Group Description Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery. Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery. Total of all reporting groups
Overall Number of Baseline Participants 102 97 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 97 participants 199 participants
64.9  (6.1) 65.2  (7.3) 65.0  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 97 participants 199 participants
Female
102
 100.0%
97
 100.0%
199
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 97 participants 199 participants
Hispanic or Latino
24
  23.5%
24
  24.7%
48
  24.1%
Not Hispanic or Latino
78
  76.5%
73
  75.3%
151
  75.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 97 participants 199 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   9.8%
5
   5.2%
15
   7.5%
White
92
  90.2%
89
  91.8%
181
  91.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   2.1%
2
   1.0%
Gravidity  
Median (Inter-Quartile Range)
Unit of measure:  Pregnancies
Number Analyzed 102 participants 97 participants 199 participants
3
(2 to 3)
2
(2 to 3)
3
(2 to 3)
Vaginal deliveries  
Median (Inter-Quartile Range)
Unit of measure:  Births
Number Analyzed 102 participants 97 participants 199 participants
2
(2 to 3)
2
(2 to 3)
2
(2 to 3)
1.Primary Outcome
Title Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse
Hide Description Cumulative failures, as measured by (i) anatomic assessment of prolapse, (ii) presence of bulge symptoms, and/or (iii) retreatment of pelvic organ prolapse
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 93 93
Measure Type: Count of Participants
Unit of Measure: Participants
18
  19.4%
8
   8.6%
2.Secondary Outcome
Title Condition Specific (i.e. Pelvic Organ Prolapse) Symptom Bother as Measured by Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire
Hide Description Questionnaire score at 12 months in overall condition-specific symptom bother as measured by Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire, which is scored from 0-300, higher scores being worse (i.e., more distressing)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 93 93
Mean (Standard Error)
Unit of Measure: score on a scale
23.1  (4.6) 23.1  (4.7)
3.Secondary Outcome
Title Condition Specific (i.e. Pelvic Organ Prolapse) Quality of Life as Measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Hide Description Questionnaire score at 12 months in overall condition-specific quality of life as measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7) questionnaire, which is scored from 0-300, higher scores being worse (i.e., more distressing)
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 93 93
Mean (Standard Error)
Unit of Measure: score on a scale
8.9  (4.5) 9.5  (4.6)
4.Secondary Outcome
Title Generic Quality of Life as Measured by SF-12 Questionnaire
Hide Description Generic (physical component) quality of life as measured by SF-12 questionnaire at 12 months. Scores range from 0-100, with higher scores indicating better physical functioning; the US population average is 50 points.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 93 93
Mean (Standard Error)
Unit of Measure: score on a scale
52.1  (0.9) 53.2  (0.9)
5.Secondary Outcome
Title Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6
Hide Description Urinary symptom bother as measured by urinary subscale questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire, i.e. the Urinary Distress Inventory, UDI-6. This is scored from 0-100, with greater scores indicating greater symptom bother.
Time Frame Time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 102 97
Mean (Standard Error)
Unit of Measure: score on a scale
38.2  (2.7) 37.7  (2.8)
6.Secondary Outcome
Title Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6
Hide Description Urinary symptom bother as measured by urinary subscale questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire, i.e. the Urinary Distress Inventory, UDI-6. This is scored from 0-100, with greater scores indicating greater symptom bother.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 93 93
Mean (Standard Error)
Unit of Measure: score on a scale
9.8  (2.1) 9.2  (2.2)
7.Secondary Outcome
Title Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire
Hide Description Urinary symptom impact on quality of life as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire. This is scored from 0-100, with greater scores indicating worse impact on quality of life.
Time Frame Time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 102 97
Mean (Standard Error)
Unit of Measure: score on a scale
26.9  (1.8) 25.2  (1.8)
8.Secondary Outcome
Title Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire
Hide Description Urinary symptom impact on quality of life as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire. This is scored from 0-100, with greater scores indicating worse impact on quality of life.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 93 93
Mean (Standard Error)
Unit of Measure: score on a scale
1.2  (1.9) 2.6  (1.9)
9.Secondary Outcome
Title Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Hide Description Sexual function in sexually-active women as measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The score ranges from 1 (worse sexual experience) to 5 (better sexual experience) with midrange scores commonly seen in women with pelvic floor disorders.
Time Frame Time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 102 97
Mean (Standard Error)
Unit of Measure: score on a scale
3.13  (0.10) 3.12  (0.10)
10.Secondary Outcome
Title Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Hide Description Sexual function in sexually-active women as measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). The score ranges from 1 (worse sexual experience) to 5 (better sexual experience) with midrange scores commonly seen in women with pelvic floor disorders.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 93 93
Mean (Standard Error)
Unit of Measure: score on a scale
3.55  (0.10) 3.70  (0.10)
11.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants reporting any adverse events from baseline randomization to 12 months postoperatively
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description:
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Overall Number of Participants Analyzed 102 97
Measure Type: Count of Participants
Unit of Measure: Participants
73
  71.6%
68
  70.1%
Time Frame From baseline randomization to 12 months postoperatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Estrogen Cream Placebo Cream
Hide Arm/Group Description Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery. Placebo Cream: 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
All-Cause Mortality
Estrogen Cream Placebo Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)      0/97 (0.00%)    
Hide Serious Adverse Events
Estrogen Cream Placebo Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/102 (9.80%)      11/97 (11.34%)    
Cardiac disorders     
Chest pain  1  0/102 (0.00%)  0 1/97 (1.03%)  1
Atrial fibrillation  1  0/102 (0.00%)  0 2/97 (2.06%)  3
Cardiac catheter ablation  1  0/102 (0.00%)  0 1/97 (1.03%)  1
Gastrointestinal disorders     
Volvulus  1  0/102 (0.00%)  0 1/97 (1.03%)  1
Immune system disorders     
Anaphylactic shock due to adverse food reaction  1  1/102 (0.98%)  1 0/97 (0.00%)  0
Infections and infestations     
Sepsis  1  1/102 (0.98%)  1 2/97 (2.06%)  2
Infection MRSA  1  1/102 (0.98%)  1 0/97 (0.00%)  0
Pneumonia  1  1/102 (0.98%)  1 0/97 (0.00%)  0
Viral infection NOS  1  0/102 (0.00%)  0 1/97 (1.03%)  1
Musculoskeletal and connective tissue disorders     
Trimalleolar fracture, closed  1  3/102 (2.94%)  3 0/97 (0.00%)  0
Fractured hip  1  1/102 (0.98%)  1 0/97 (0.00%)  0
Rheumatoid arthritis  1  0/102 (0.00%)  0 1/97 (1.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Carcinoma breast stage II  1  1/102 (0.98%)  1 0/97 (0.00%)  0
Endometrial carcinoma  1  1/102 (0.98%)  1 1/97 (1.03%)  1
Nervous system disorders     
Stroke  1  1/102 (0.98%)  1 0/97 (0.00%)  0
Renal and urinary disorders     
Stress urinary incontinence  1  0/102 (0.00%)  0 1/97 (1.03%)  1
Surgical and medical procedures     
Bladder injury  1  0/102 (0.00%)  0 1/97 (1.03%)  1
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Estrogen Cream Placebo Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/102 (54.90%)      51/97 (52.58%)    
Gastrointestinal disorders     
Nausea and vomiting  1  7/102 (6.86%)  7 6/97 (6.19%)  6
Constipation  1  3/102 (2.94%)  3 5/97 (5.15%)  5
Infections and infestations     
Urinary tract infection  1  18/102 (17.65%)  20 22/97 (22.68%)  32
Yeast infection  1  10/102 (9.80%)  10 6/97 (6.19%)  6
Injury, poisoning and procedural complications     
Granulation tissue  1  7/102 (6.86%)  7 3/97 (3.09%)  3
Reproductive system and breast disorders     
Dyspareunia  1  6/102 (5.88%)  6 5/97 (5.15%)  5
Vaginal itching  1  6/102 (5.88%)  6 4/97 (4.12%)  4
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David D. Rahn
Organization: University of Texas Southwestern Medical Center Dallas
Phone: 12146486430
EMail: david.rahn@utsouthwestern.edu
Layout table for additonal information
Responsible Party: David Rahn, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02431897    
Other Study ID Numbers: STU 022015-117
First Submitted: April 23, 2015
First Posted: May 1, 2015
Results First Submitted: November 16, 2022
Results First Posted: December 16, 2022
Last Update Posted: September 6, 2023