Vaginal Electrical Stimulation Versus Neuromodulation

Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01525485

Acronym

Estim

Enrollment

Registered

2012-02-03

Start date

2011-03-31

Completion date

2016-04-30

Last updated

2016-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Overactive Bladder

Brief summary

This prospective study compares quality of life measures of patients with refractory overactive bladder, between two modes of neuromodulation: vaginal electrical stimulation (Group A) and sacral nerve stimulation (Group B). The specific aims are: 1\. To characterize patient symptom bother score, quality of life, and body image scores in patients obtaining sacral nerve stimulation, as compared to vaginal electrical stimulation. \- Hypothesis 1: Both modes of neuromodulation will impact patients' scores in quality of life, patient symptoms, and body image questionnaires.

Detailed description

All participants will have a standardized intake history which will include age, weight, history of prior treatment for incontinence, medication list, obstetric and gynecologic history, medical history, and surgical history, as well as a complete review of systems. The physical examination will include vital signs (including BMI), genitourinary exam, including Pelvic Organ Prolapse Quantification (POPQ), and neurologic exam. All patients will undergo spontaneous uroflowmetry, urine dipstick from catheterized specimen, multichannel urodynamics, and 3-day voiding diary. Measurement of post-void residual will also be obtained. Completion of the UDI-69, King's Health Questionnaire10, and the Modified Body Image Perception Scale (MBIS) will also be part of the initial visit 11,12. All participants taking anticholinergics will undergo a 2 week flush-out period prior to the intake assessment. After the intake assessment, the provider will determine which treatment option is appropriate to the participant, and they will then be assigned to one of the two treatment arms: Group A will use vaginal electrical stimulation using the Empi Intravaginal Stimulation Unit Minnova (Empi, St. Paul, MN, USA) and participants in Group B will receive sacral neuromodulation using InterStim (Medtronic, Minneapolis, MN, USA).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of refractory OAB (+/- UUI)\* * Female Gender * Eligible for both treatment interventions * Available for 8 weeks of follow-up * Able to complete study assessments * Must discontinue anticholinergics within 2 weeks of intervention

Exclusion criteria

* Age \< 21 * Pregnancy * Stage 3 or 4 pelvic organ prolapse * Current use of anticholinergics * Urinary tract infection * Undergoing concurrent treatment for pelvic organ prolapse * Unstable or serious cardiac arrhythmia * Implanted pacemaker * Postvoid residual \> 100ml * Unstable seizure disorder * Dementia or inability to follow instructions

Design outcomes

Primary

Measure	Time frame	Description
Symptom improvement	3 months	\>50% improvement in symptoms and decrease in frequency of voids and episodes of nocturia. Subjective outcomes will be measured by improvement in scores on the UDI-6, KHG, and MBIS.

Countries

United States

Outcome results