Vaginal Electrical Stimulation Versus Neuromodulation (Estim)
Vaginal Electrical Stimulation Versus Sacral Neuromodulation for the Treatment of Refractory Overactive Bladder: A Pilot Study
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- University of Oklahoma Health Sciences Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Electrical Stimulation
Participants will have a dedicated visit with a pelvic floor physical therapist during which instructions on usage and technique for the Minnova unit will be given.
The electrical parameters selected will be: 10 Hertz frequency, 5-second on/10=second off cycle, and a pulse width of 0.4 milliseconds.
The bipolar square will be delivered over a range that varies from 0 to 100 milliamps, depending on the maximum current intensity comfortably tolerated by the patient.
The participant will perform each treatment session for 20 minutes twice daily for 8 weeks.
Participants will be asked to keep a log recording the dates, times, and duration of each treatment session.
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Interstim device
Participants assigned to the sacral neuromodulation group will undergo InterStim device placement by one of the three Urogynecologists at OUHSC using a staged implant technique according to manufacturer's specifications.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Symptom improvement
Lasso di tempo: 3 months
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>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.
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3 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: S. Abbas Shobeiri, MD, Univerisity of Oklahoma Health Sciences Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1104
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