- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01806350
Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors
A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training.
II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training.
III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.
ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
After completion of study treatment, patients are followed up at 3 months.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87106
- University of New Mexico Cancer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- History of uterine, cervical, ovarian or vulvar malignancy
- Treatment free interval of >= one year and currently have no evidence of cancer
- Reports urinary incontinence based on screening questionnaire
- Must have a stable address for the three month period
Exclusion Criteria:
- Current clinical evidence of urinary tract infection
- Within three months of failed surgery for urinary incontinence
- Planned surgery for urinary incontinence in the next three months
- Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke
- Pregnancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm I (PFMT)
Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials.
Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles.
Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.
|
Etudes annexes
Undergo PFMT
Autres noms:
|
|
Comparateur actif: Arm II (usual care)
Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.
|
Etudes annexes
Receive usual care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Improvement in the Patient Global Impression of Improvement (PGI-I) rating
Délai: 12 weeks
|
Fisher's exact test will be used to test whether the chance of success is identical for the two groups (intervention vs. control).
|
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in the Incontinence Severity Index (ISI) score
Délai: Baseline to 3 months
|
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner.
A two sample t-test on the within individual differences will be used.
A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
|
Baseline to 3 months
|
|
Changes in Urinary Distress Inventory (UDI)
Délai: Baseline to 3 months
|
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner.
A two sample t-test on the within individual differences will be used.
A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
|
Baseline to 3 months
|
|
Changes in Incontinence Impact Questionnaire (IIQ), which measures the impact of urinary incontinence on quality of life
Délai: Baseline to 3 months
|
The Brinks scale will be used by the trainers for the treatment group follow-up to evaluate the adequacy of the contractions in a qualitative manner.
A two sample t-test on the within individual differences will be used.
A non-parametric Mann-Whitney test will be used if the sample differences are non-normally distributed.
|
Baseline to 3 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Teresa Rutledge, MD, University of New Mexico Cancer Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
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
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Maladies urologiques
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Symptômes des voies urinaires inférieures
- Manifestations urologiques
- Tumeurs utérines
- Tumeurs génitales, femme
- Maladies utérines
- Maladies du système endocrinien
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Tumeurs des glandes endocrines
- Troubles urinaires
- Maladies vulvaires
- Tumeurs ovariennes
- Incontinence urinaire
- Tumeurs de l'endomètre
- Carcinome épithélial ovarien
- Tumeurs vulvaires
Autres numéros d'identification d'étude
- INST 0912
- NCI-2012-01319 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
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