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Intravaginal Electrical Stimulation in Idiopathic Overactive Bladder

NCT04389307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-05-25

No results posted yet for this study

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.

Conditions

  • Idiopathic Overactive Bladder
  • Electrical Stimulation
  • Bladder Training

Interventions

OTHER

Electrical stimulation (IVES)

IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24 session treatment program of IVES.

OTHER

Bladder Training

Bladder Training

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-12-01
Completion
2020-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04389307 on ClinicalTrials.gov