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

NCT05416450 | Unknown

• 1 other identifier: PamukkaleU-Unal-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bladder training; intravaginal electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Incontinence episodes (positive response rate)

  To determine positive response rate, reduction in incontinence episodes was collected from the 3-day bladder diary. Women with ≥a 50% reduction in incontinence episodes were considered positive responders.

  Change from baseline at the 8th week after the treatment

Secondary Outcomes (6)

• the severity of incontinence

  Change from baseline at the 8th week after the treatment

• symptom severity

  Change from baseline at the 8th week after the treatment

• frequency of voiding

  Change from baseline at the 8th week after the treatment

• nocturia

  Change from baseline at the 8th week after the treatment

• number of pads

  Change from baseline at the 8th week after the treatment

Study Arms (2)

Antimuscarinic Naive (AM-N)

ACTIVE COMPARATOR

None of the women had previously taken anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) in this group.

Device: intravaginal electrical stimulation added to bladder training

Antimuscarinic Refractory (AM-R)

ACTIVE COMPARATOR

Women with idiopathic OAB refractory to anti-muscarinic agents and oral ß3 adrenoreceptor agonist (mirabegron) when 2 or more were administered for at least 6 weeks each and failure was due to lack of efficacy with or without side effects were included in this group.

Device: intravaginal electrical stimulation added to bladder training

Interventions

intravaginal electrical stimulation added to bladder training DEVICE

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.

Antimuscarinic Naive (AM-N); Antimuscarinic Refractory (AM-R)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18 with the clinical diagnosis of idiopathic OAB
• Who could able to give written informed consent and understand the procedures

You may not qualify if:

• Women who had stress urinary incontinence
• A history of conservative therapy (BT, ES) for OAB within 6 months
• Urogynecological surgery within 3 months
• Current vulvovaginitis or urinary tract infections or malignancy
• Pregnancy
• Cardiac pacemaker or implanted defibrillator
• Anatomic structural disorders of the genital region that did not allow to apply the vaginal probe
• The strength of PFM less than 3/5 (graded as modified Oxford scale, min:0-max:5)
• The pelvic organ prolapse quantification (POP-Q) (stage 2 or more)
• Neurogenic bladder
• The peripheral or central neurologic pathology
• Ultrasonographic evidence of post-void residual urine volume more than 100 ml
• Allergy to condom or lubricant gel that is used with vaginal probe

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale Univercity

Denizli, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Yildiz N, Unal B. Comparison of the efficacy of intravaginal electrical stimulation in women with idiopathic overactive bladder naive and refractory to pharmacological agents. Int Urogynecol J. 2023 Sep;34(9):2099-2105. doi: 10.1007/s00192-023-05517-1. Epub 2023 Mar 28.

  PMID: 36976326 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Necmettin Yıldız, Prof

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Burak Unal, M. D.

CONTACT

+905466033240; burakunal_3293@hotmail.com

Necmettin Yıldız, Prof

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: July 1, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 5, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

TU (1)