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The Efficacy of Intravaginal Electrical Stimulation in Women With Idiopathic Overactive Bladder

NCT05416450 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-11-01

No results posted yet for this study

Summary

In this study, it was aimed to compare the effectiveness of intravaginal electrical stimulation (IVES) added to bladder training (BT) on quality of life (QoL) and clinical parameters related to overactive bladder (OAB) in antimuscarinic naive and refractory women. The results of this study would make it easier to understand the place of IVES among the treatment options in women with idiopathic OAB.

Conditions

  • Urinary Bladder, Overactive

Interventions

DEVICE

intravaginal electrical stimulation added to bladder training

BT was given as a home program. After information session, squeezing the PFM was shown in practice at least once to use in the urgency suppression strategies via digital palpation technique. The second stage strategies was aimed to delay urination, inhibit detrusor contraction, and prevent urgency by squeezing the PFM several times on a row, breathing deeply and self-motivating. In the third stage, a timed voiding program was started; a timed voiding and increasing the time between urination considering the voiding diary. IVES was applied in addition to BT in both groups. It was performed in lithotomy position via a stimulation device (Enraf Nonius Myomed 632) with a vaginal probe; three days a week, a total of 24 sessions for 8 weeks. Every session lasted 20 minutes. The stimulation parameters were a 10 Hz of frequency, a 5-10 s of work-rest cycle duration and, a 100 ms of pulse width. The symmetric biphasic pulse wave could be delivered over a range of 1-100 mA.

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Principal Investigators

  • Necmettin Yıldız, Prof · Pamukkale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-12-15
Completion
2023-01-05

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 NCT05416450 on ClinicalTrials.gov