Œstrogène périurétral vs intravaginal pour la prévention des infections récurrentes des voies urinaires (TAPER)
Œstrogènes périurétraux vs intravaginaux pour la prévention des infections récurrentes des voies urinaires : essai TAPER (techniques d'application d'œstrogènes vaginaux pour la prévention des infections récurrentes des voies urinaires)
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Pennsylvania
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Cranberry Township, Pennsylvania, États-Unis, 16066
- UPMC Lemieux Sports Complex
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Erie, Pennsylvania, États-Unis, 16550
- UPMC Hamot
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh Medical Center-Magee Womens Hospital
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Pittsburgh, Pennsylvania, États-Unis, 15237
- UPMC Passavant-McCandless
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Who Are UTI-free at 6 Months
Délai: 6 months
|
The primary outcome was the percentage of participants who were UTI-free at 6 months after study drug initiation. |
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Urinary Symptoms at 6 Months
Délai: 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
Délai: 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
Délai: Baseline, 6 months
|
Assessment using pH strips during pelvic examination |
Baseline, 6 months
|
|
Participant Experience With Study Drug
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 6 months
|
E. coli is a common uropathogen and thus was investigated in the pilot translational sub-aim of this research study. |
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Stephanie W Zuo, MD, University of Pittsburgh Medical Center
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY22010147
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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