Clinical trial NCT04389307: Intravaginal Electrical Stimulation in Idiopathic Overactive Bladder
Official title: Bladder Training With and Without Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Overactive Bladder
Electrical Stimulation
Bladder Training
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overactive bladder (OAB) is a symptom complex defined as urgency, with or without urge urinary incontinence (UUI), usually with frequency and nocturia, in the absence of urinary tract infection. Currently, a wide range of therapeutic options exist for the treatment of OAB. These include first-line conservative (physical) therapies which focus on electrical stimulation (ES) and behavioral therapies such as lifestyle modifications, bladder training (BT), pelvic floor muscle training with or without biofeedback, second-line therapies which are pharmacologic, and third-line therapies which either neuromodulate or chemodenervate the bladder.

In clinical practice, BT and Intravaginal ES (IVES) are frequently used together in the treatment of women with OAB, but the evidences/results of the combined (BT+IVES) use of these two treatment options are so rare that they can be neglected in the literature. There is only one study including BT+ES treatment arm (one of the four treatment arms) in women with idiopathic OAB in the literature. In a study, BT+ES was not found to be effective both from BT alone and from the untreated control group. While interpreting the results of this study, it should be take into consideration that patients treated received relatively few treatment sessions (nine treatment sessions, once weekly) in this study. In addition, in the light of authors clinical experience, the investigators think that this issue is still open for research. Moreover, there is no recommendation on conservative combinations in the guidelines due to insufficient data.

This study is the first prospective randomized controlled trial that compares the efficacy of BT and BT plus IVES in women with idiopathic OAB. In this study, the investigators aimed to evaluate the efficacy of BT with and without IVES on incontinence-related QoL and clinical parameters in women with idiopathic OAB.


Eligibility criteria: Inclusion Criteria:

* Women over the age of 18 with clinical diagnosis of idiopathic OAB
* Urodynamically diagnosed detrusor overactivity
* The strength of pelvic floor muscle 3/5 and more
* Able to give written, informed consent
* Able to understand the procedures, advantages and possible side effects
* Willing and able to complete the voiding diary and QoL questionnaire

Exclusion Criteria:

* History of conservative therapy (BT, ES) for OAB within 3 months
* Previously treated with antimuscarinics (within 4 weeks)
* Pregnancy or intention to become pregnant during the study
* Current vulvovaginitis or urinary tract infections or malignancy
* History of urogynecological surgery within 3 months
* Anatomic structural disorders of genital region that could not allow to apply the vaginal probe
* Having stage 2 or more according to the pelvic organ prolapse quantification
* Cardiac pacemaker or implanted defibrillator
* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
* Ultrasonographic evidence of residual urine volume more than 100 ml
* Allergy to condom or lubricant gel that is used with perineometer/vaginal probe

Primary outcomes:
measure: incontinence episodes-incontinence related outcomes measures
timeFrame: 8 weeks
Secondary outcomes:
measure: frequency of voiding-incontinence related outcomes measures
timeFrame: 8 weeks
measure: nocturia frequency- incontinence related outcomes measures
timeFrame: 8 weeks
measure: incontinence related quality of life questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Hakan Alkan
state: None Selected
Study officials:
References: