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Completed

NCT Number: NCT01558856

Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

The primary objective of this study is to compare the efficacy of unilateral and bilateral neuromodulation tests at 1 month.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Beau Soleil, Montpellier, France

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About this study

The secondary objectives of this study are to compare the following elements between a group of patients undergoing unilater modulation tests (standard procedure) and a group of patients undergoing bilateral neuromodulation tests (experimental procedure) (at 1 month): Pollakiuria, pad use, urge incontinence, symptom severity, % of patients not eligible for an implant, debimetry, tolerance, complications, quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 1 month of follow-up
  • The patient understands and reads French
  • The patient has symptoms of overactive bladder resistant to first-line treatments (physiotherapy, anticholinergics)
  • The patient suffers from an overactive bladder confirmed by a urodynamic panel
  • The patient suffers from an overactive bladder unassociated with bladder obstruction as confirmed by flowmetry
  • The patient has primary (idiopathic) overactive bladder primary with normal urinalysis, abdominal and pelvic ultrasound, urine cytology + / - cystoscopy
  • The patient has no bleeding disorders, or the disorder is properly controlled after treatment

Exclusion criteria

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • Overactive bladder associated with bladder obstruction as determined by flowmetry
  • Overactive bladder unconfirmed by urodynamic panel
  • Overactive bladder secondary to another condition:
  • vesical: urolithiasis, bladder polyp, interstitial cystitis
  • pelivienne: tumor or inflammatory
  • neurological: multiple sclerosis, brain tumor, epilepsy
  • the patient has an uncorrectable bleeding disorder

Treatment and study plan

Unilateral electrode placement and testing

Procedure

An electrode is placed near a sacral nerve with an anal motor response under general anesthesia. During and adjustment phase, the electode is connected to a test box which allows for adjustment of stimulation parameters. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.

Bilateral electrode placement and testing

Procedure

Two electrodes are placed, one near each sacral nerve under general anesthesia. During an adjustment phase, the electodes are connected to a test box which allows for adjustment of stimulation parameters. This can result in the use of one or the other, or both electrodes, thus increasing the chances of success and the possibility that the patient is eligible for an implant. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.

Primary outcomes

  1. Success rate

    Time frame: 1 month

    "Success" is defined as a >= 50% improvement in at least one of the following symtoms: pollakiuria, number of urge incontinence episodes with incontinence, number of urge incontinence episodes.

Secondary outcomes

  1. presence/absence: 50% reduction in the number of daily mictions

    Time frame: 1 month

  2. presence/absence: 50% reduction in the number of pads/protections used per day

    Time frame: 1 month

  3. presence/absence: 50% reduction in the number of urge incontinence episodes per day

    Time frame: 1 month

  4. presence/absence: 50% reduction in the number of urge incontinence episodes with incontinence per day

    Time frame: 1 month

  5. Symptom severity as measured by the MHU score

    Time frame: 1 month

    MHU = Mesure Hanicap Urinaire

  6. Yes/no: the patient was eligible for an implant

    Time frame: 1 month

  7. debimetry: flow rate per voiding

    Time frame: 1 month

  8. debimetry: urinary volume per voiding

    Time frame: 1 month

  9. Visual analog scale for pain at the implantation site

    Time frame: 1 month

  10. Visual analog scale for pain due to neuro stimulation (pain in legs or buttocks)

    Time frame: 1 month

  11. Presence/absence of infection of the implant or electrode

    Time frame: 1 month

  12. Change in quality of life: IQoL score

    Time frame: baseline to 1 month

  13. Change in quality of life: KHQ score

    Time frame: baseline to 1 month

  14. Change in quality of life: SF 36 score

    Time frame: baseline to 1 month

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Prospective Randomized Trial Comparing Unilateral and Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder

Acronym: HAVIR Bi

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Mar 20, 2012
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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