再発性尿路感染症の予防のための尿道周囲 vs 膣内エストロゲン (TAPER)
再発性尿路感染症の予防のための尿道周囲 vs 膣内エストロゲン：TAPER（再発性尿路感染症の予防のための膣エストロゲン適用技術）試験
Due to rising antibiotic resistance, there has been a focus on non-antibiotic prophylactic measures for postmenopausal patients with recurrent urinary tract infections (rUTI), one of which is the safe and efficacious option of vaginal estrogen therapy. Standard application of vaginal estrogen cream entails intravaginal application of the cream twice a week, but some providers counsel patients with rUTI to apply a small, pea-sized amount to the periurethral area. This ideally reduces the amount of vaginal estrogen used while attaining a similar effect. However, to date, there is no data to prove that the periurethral technique of application is similar or non-inferior to intravaginal application in preventing UTI.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Pennsylvania
-
Cranberry Township、Pennsylvania、アメリカ、16066
- UPMC Lemieux Sports Complex
-
Erie、Pennsylvania、アメリカ、16550
- UPMC Hamot
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center-Magee Womens Hospital
-
Pittsburgh、Pennsylvania、アメリカ、15237
- UPMC Passavant-McCandless
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Postmenopausal (definition: No menses for 1 or more years or surgical menopause (bilateral oophorectomy). If there is a past history of hysterectomy, patient must be age 56 or older (95th percentile for age at menopause) or have laboratory evidence of menopause (ie. FSH >30)
- Meets criteria for recurrent urinary tract infections (UTIs) with 2 or more UTI in 6 months or 3 or more UTI in 1 year
- May include patients who used vaginal estrogen previously if they have stopped use for 3 or more months prior to inclusion into study.
- Patients must be recommended vaginal estrogen as part of normal clinical care for prevention of recurrent UTI
Exclusion Criteria:
- Current use of vaginal or oral estrogen products
- Inability or refusal to use vaginal estrogen
- Daily antibiotic use
- Significant vaginal stenosis (eg. due to lichen sclerosis, radiation or obliterative prolapse surgery) that would prohibit use of a vaginal applicator (ie. genital hiatus <1cm)
- Inability to use vaginal applicator and without caregiver who can administer (eg. provider-managed pessary use, significant arthritis)
- Frequent (1x weekly or more frequent) use of bladder instillations containing an antibiotic
- Known hydronephrosis as a result of incomplete bladder emptying
- Use of intermittent or indwelling urinary catheterization
- Known bladder stones, mesh erosion into bladder, or foreign object in bladder
- Unable to consent for self
- Active treatment for an estrogen-dependent malignancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Intravaginal Estrogen Application
Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months |
The control group will apply 1 gram estradiol cream intravaginally using an applicator. |
|
実験的：Periurethral Estrogen Application
Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months |
The experimental group will apply estradiol cream in a different location (periurethral) and at a smaller dose (0.5 gram) compared to the control group. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Who Are UTI-free at 6 Months
時間枠：6 months
|
The primary outcome was the percentage of participants who were UTI-free at 6 months after study drug initiation. |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Urinary Symptoms at 6 Months
時間枠：Baseline, 6 months
|
Questionnaire assessment of urinary symptoms and symptom distress (Urogenital Distress Inventory, Short Form), total score range 0-100 with higher numbers representing worse urinary symptoms |
Baseline, 6 months
|
|
Change From Baseline in Sexual Function at 6 Months
時間枠：Baseline, 6 months
|
Questionnaire assessment of sexual function (Female Sexual Function Index-6) with scores ranging from 2 to 30, with 19 and below denoting sexual dysfunction. |
Baseline, 6 months
|
|
Change From Baseline in Vaginal pH at 6 Months
時間枠：Baseline, 6 months
|
Assessment using pH strips during pelvic examination |
Baseline, 6 months
|
|
Participant Experience With Study Drug
時間枠：6 months
|
Agreement with the statement: "I am satisfied with the estrogen cream." (Positive response of "agree" or "strongly agree" on 5-point Likert Scale) |
6 months
|
|
Vaginal Maturation Value
時間枠：3 months
|
Vaginal maturation value at 3 months (score 0-100, higher values correlating with greater vaginal estrogenization) |
3 months
|
|
Average Amount of Estrogen Used Per Tube
時間枠：6 months
|
Study drug tubes were weighed at baseline and then at follow-up visits (weight in grams) and the average amount of study drug used per tube was calculated. |
6 months
|
|
Percentage of Participants With Lactobacillus Crispatus Positive Vaginal Specimens
時間枠：6 months
|
Lactobacillus crispatus is a species of Lactobacillus known to assist with UTI prevention through the maintenance of an acidic environment. It generally is elevated in the vagina in the presence of estrogen. |
6 months
|
|
Percentage of Participants With E. Coli Positive Vaginal Specimens
時間枠：6 months
|
E. coli is a common uropathogen and thus was investigated in the pilot translational sub-aim of this research study. |
6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Stephanie W Zuo, MD、University of Pittsburgh Medical Center
出版物と役立つリンク
一般刊行物
- Zuo SW, Bradley M, Mowers EE, Zyczynski HM, Hillier SL, Ackenbom MF. Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial. Contemp Clin Trials. 2025 Jun;153:107893. doi: 10.1016/j.cct.2025.107893. Epub 2025 Mar 30.
- Zuo SW, Mowers EE, Hem S, Bradley M, Zyczynski HM, Hillier SL, Ackenbom MF. Vaginal Estrogen Application Techniques for Prevention of Urinary Tract Infection: A Randomized Trial. Obstet Gynecol. 2026 Jul 27. doi: 10.1097/AOG.0000000000006376. Online ahead of print.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY22010147
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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