Who is sponsoring IMPROVE?

IMPROVE is sponsored by University of Texas Southwestern Medical Center.

What condition does IMPROVE study?

IMPROVE studies Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse, Vaginal Prolapse, Pelvic Floor Disorders.

What drugs are being tested in IMPROVE?

Interventions: Conjugated Estrogens Cream, Placebo Cream.

What is the status of IMPROVE?

IMPROVE is currently COMPLETED.

Last reviewed 2023-08-23 · How we verify

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

NCT02431897 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 4
Status	COMPLETED
Enrolment	206
Start date	2016-12
Completion	2023-05-17

Conditions

Pelvic Organ Prolapse
Urogenital Prolapse
Vaginal Vault Prolapse
Cystocele
Uterine Prolapse
Vaginal Prolapse
Pelvic Floor Disorders

Interventions

Conjugated Estrogens Cream
Placebo Cream

Primary outcomes

Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse — 12 months
Cumulative failures, as measured by (i) anatomic assessment of prolapse, (ii) presence of bulge symptoms, and/or (iii) retreatment of pelvic organ prolapse

Countries

United States