Clinical Trials Logo
  1. Home
  2. Overactive Bladder
  3. NCT04831801
  4. Details
NCT04831801 Clinical Trial

OAB and the Microbiome

Overactive Bladder Clinical Trial

Official title:
Trends in the Microbiome Profiles of Women With Urgency and Frequency Syndrome, With or Without Pelvic Pain?

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04831801
Other study ID # 20201001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 30, 2021
Est. completion date November 20, 2023

Study information
Verified date May 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).

Recruitment information / eligibility
Status Terminated
Enrollment 39
Est. completion date November 20, 2023
Est. primary completion date November 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 18 y/o-90 y/o - Able to consent - Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or 2. - Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2. Exclusion Criteria: - Pregnant - Pelvic radiation - Urinary retention (>200 ml) - Renal calculi - Recurrent urinary tract infection (UTI) (2 in 6 months), or - Current UTI - Immunosuppressed or radiation history - Neurologic disorder

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Holy Cross Hospital Fort Lauderdale Florida
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with Lactobacillus in samples. Evaluation of urine and perineal samples by PCR. Day 1
Primary Proportion of patients negative for repeat sequencing. Evaluation of urine and perineal samples by PCR. Day 1
Primary Proportion of patients with change in UDI-6 score UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome. Up to 4 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04578899 - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity" N/A
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Completed NCT00928070 - A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder Phase 4