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Completed

NCT Number: NCT00928395

Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms

This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gregory L. Davis, M.D., FACOG, Inc., Chico, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
  • Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
  • Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
  • Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
  • Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
  • Subjects must remain off all antimuscarinics throughout participation in trial
  • Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
  • Capable of giving informed consent
  • Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years

Exclusion criteria

  • Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
  • Subjects who were not able or willing to follow original SUmiT Trial study schedule

Treatment and study plan

Urgent PC

Device

The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

Primary outcomes

  1. Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline

    Time frame: 36 months total

    The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).

Secondary outcomes

  1. GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.

    Time frame: every three months for 36 months

  2. Change in OAB-q and SF-36 Questionnaires.

    Time frame: every three months for 36 months

  3. Change in Voiding Diary Parameters.

    Time frame: every three months for 36 months

Sponsors and collaborators

Lead sponsor

Uroplasty, Inc

Industry

Registry information

Official study title

Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation

Acronym: STEP

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 26, 2009
Registry last updated
May 16, 2013

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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