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

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ClinicalTrials.gov Identifier: NCT02431897
Recruitment Status : Recruiting
First Posted : May 1, 2015
Last Update Posted : May 6, 2019
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

Tracking Information
First Submitted Date  ICMJE April 23, 2015
First Posted Date  ICMJE May 1, 2015
Last Update Posted Date May 6, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
Surgical "success" or "failure" defined by (i) anatomic assessment of prolapse, (ii) presence or absence of bulge symptoms, (iii) retreatment of prolapse [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02431897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • Condition specific (i.e. pelvic organ prolapse) quality of life as measured by Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Condition specific (i.e. pelvic organ prolapse) quality of life as measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7) [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Generic quality of life as measured by SF-12 questionnaire [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • 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 [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in questionnaire scores from baseline to time of surgery
  • 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 [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Urinary symptoms as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in questionnaire scores from baseline to time of surgery
  • Urinary symptoms as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Sexual function as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in questionnaire scores from baseline to time of surgery
  • Sexual function as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Number of participants with adverse events [ Time Frame: through 12 months ]
    Comparison of proportions by treatment group
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
  • Condition specific (i.e. pelvic organ prolapse) quality of life as measured by Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Condition specific (i.e. pelvic organ prolapse) quality of life as measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7) [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Generic quality of life as measured by SF-12 questionnaire [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • 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 [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in questionnaire scores from baseline to time of surgery
  • 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 [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Urinary symptoms as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in questionnaire scores from baseline to time of surgery
  • Urinary symptoms as measured by urinary subscale questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Overactive bladder symptoms (urinary frequency) as measured by voiding diary [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in voiding frequency from baseline to time of surgery
  • Stress urinary incontinence as measured by cough stress test [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in proportion of patients with/without positive cough stress test from baseline to time of surgery
  • Sexual function as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [ Time Frame: Baseline, time of surgery (8 wk) ]
    Change in questionnaire scores from baseline to time of surgery
  • Sexual function as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [ Time Frame: Baseline, 12 months ]
    Change in questionnaire scores from baseline to 12 months
  • Number of participants with adverse events [ Time Frame: through 12 months ]
    Comparison of proportions by treatment group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Official Title  ICMJE Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Brief Summary This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.
Detailed Description This is a double-blind randomized trial of intravaginal estrogen (conjugated estrogens, 0.625mg/1g cream) vs. placebo in postmenopausal women (n=222 total) with symptomatic prolapse beyond the hymen planning transvaginal native tissue repairs. Medication will be started >5 weeks before surgery and continued for 1 year postoperatively, i.e. until scar remodeling is complete. The investigators aim to determine if pre- and postoperative intravaginal estrogen therapy (i) results in anatomic and patient-reported subjective improvement in pelvic organ support, and (ii) impacts other pelvic floor disorders (overactive bladder and incontinence, sexual function and pain, postoperative cystitis), satisfaction, quality of life, and vaginal wound healing. Finally, (iii) the investigators will determine the potential mechanisms by which local estrogen treatment alters pelvic organ support by examining full-thickness vaginal wall biopsies taken at the time of surgery for histologic, connective tissue, and smooth muscle synthesis and degradative changes. The investigators expect this will highlight other novel targets for future therapies in prolapse repair and prevention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Organ Prolapse
  • Urogenital Prolapse
  • Vaginal Vault Prolapse
  • Cystocele
  • Uterine Prolapse
  • Vaginal Prolapse
  • Pelvic Floor Disorders
Intervention  ICMJE
  • Drug: 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.
    Other Name: Premarin Vaginal Cream
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Estrogen Cream
    Intervention: Drug: Conjugated Estrogens Cream
  • Placebo Comparator: Placebo Cream
    Intervention: Drug: Placebo Cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2015)
222
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2015)
276
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal: no menses for >1 year
  • Minimum age: 48 years
  • Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
  • No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
  • Medically fit for elective surgery
  • Physically able to apply/insert the study drug
  • Available for clinic follow-up for minimum 1yr

Exclusion Criteria:

  • Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
  • BMI >35 kg/m2
  • Recent history (within last month) of vaginal infection or vaginitis
  • Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
  • History of connective tissue disease
  • Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu
  • History of vaginal irradiation
  • Allergy to Premarin or its constituents
  • Prior apical repair or use of mesh for prolapse repair
  • Current tobacco use
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 48 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David D Rahn, MD 214-648-6430 david.rahn@utsouthwestern.edu
Contact: Agnes Burris, RN 214-645-3833 agnes.burris@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02431897
Other Study ID Numbers  ICMJE AG047290-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Rahn, MD, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • University of Alabama at Birmingham
  • Women and Infants Hospital of Rhode Island
  • Pfizer
Investigators  ICMJE
Principal Investigator: David D Rahn, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP