Cervical Cancer Clinical Trial
Official title:
A Pilot Randomized Control Trial to Evaluate Pelvic Floor Muscle Training for Urinary Incontinence Among Gynecologic Cancer Survivors
This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT03367871 -
Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Withdrawn |
NCT04806945 -
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
|
Phase 3 | |
Active, not recruiting |
NCT04185389 -
Long-Term Follow-Up of HPV FOCAL Participants
|
||
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Completed |
NCT05120167 -
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
|
N/A | |
Recruiting |
NCT05483491 -
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
|
Phase 1 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Completed |
NCT05862844 -
Promise Women Project
|
N/A | |
Recruiting |
NCT04934982 -
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)
|
N/A | |
Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
Terminated |
NCT04864782 -
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A |