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Comparison of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women

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ClinicalTrials.gov Identifier: NCT02723279
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary:
The purpose of this study is to compare the efficacy of electrical pudendal nerve stimulation (EPNS) and Tolterodine Tartrate in patients with urgency-frequency syndrome.

Condition or disease Intervention/treatment Phase
Urgency-frequency Syndrome Behavioral: EPNS Drug: TT Not Applicable

Detailed Description:

Tolterodine Tartrate is one of the first-line medications in treatment of Urgency-frequency syndrome (UFS) patients. It is reported to reduce frequency urgency and nocturia and urinary leakage in patients with UFS. However dry mouth and constipation are the most frequently reported adverse events. In other reports blurred vision and increased heart rate are also reported. The side effects limit its application.

Electrical neuromodulation has proved to be valuable in patients with UFS with little adverse effect. The investigators have previously reported electrical pudendal nerve stimulation (EPNS) alone has long term effect in treatment of UFS in women patients. EPNS is developed by combining the advantages of pudendal nerve stimulation (PNS) and percutaneous tibial nerve stimulation (PTNS), and incorporating the technique of deep insertion of long acupuncture needles. Because pudendal nerve (PN) afferents are particularly important for the inhibitory effect on the voiding reflex and SNS only excites part of PN afferents, direct PN stimulation may be more effective. PNS can be used to treat UFS refractory to SNS, but this therapy also has the disadvantages similar to those of SNS. PTNS is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but the results of chronic PTNS treatment are unknown in initially successful patients and PTNS effects diminish over time.

In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves. CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Besides the radiographic evidence, simultaneous records of perineal ultrasonographic PFM contraction, vaginal pressure and pelvic floor surface electromyogram in the investigators previous study have proved that EPNS can exactly excite PN. The investigators previous study has also proved that EPNS has a good post-treatment effect on UFS in women. The purpose of the present study is to show the long-term efficacy of EPNS for UFS in women.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Study on Efficacies of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EPNS group Behavioral: EPNS
Electrical pudendal nerve stimulation Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. On the upper points, a needle of 0.40 Х 100 mm is inserted perpendicularly to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The locations of the two lower points are about 1 cm bilateral to the tip of the coccyx. On the lower points, a needle of 0.40 Х 100 or 125 mm is inserted obliquely towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally inserted needles.
Other Name: electrical pudendal nerve stimulation

Active Comparator: TT group Drug: TT
Tolterodine tartrate (GSK, UK) 4mg per day is taken orally for six weeks
Other Name: Tolterodine tartrate




Primary Outcome Measures :
  1. Lower urinary tract syndrome score [ Time Frame: 6 weeks ]
    International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) is used

  2. Quality of life score [ Time Frame: 6 weeks ]
    International Consultation on Incontinence Questionnaire-Quality of life (ICIQ-qol) is used



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urgency with a documented daytime frequency of more than eight voids and/or nocturia of more than one void.

Exclusion Criteria:

  • Age <18 years,or >80 years;
  • Urinary tract infections based on results of urinalysis or urine culture;
  • Painful bladder syndrome manifested by suprapubic pain related to bladder filling accompanied by frequency and other diseases (including interstitial cystitis, neurogenic bladder, bladder tumor, and vesical calculus)
  • Causative of urgency and frequency confirmed by physical examination, B-scan ultrasonography.

urodynamic study, cystoscopy, and radiography


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723279


Locations
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China
Shanghai research institute of acupuncture and meridian
Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
RenJi Hospital
Investigators
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Principal Investigator: Siyou Wang Shanghai University of Traditional Chinese Medicine affliated Yueyang Hospital

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Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT02723279     History of Changes
Other Study ID Numbers: 201512ZYSUFS
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shanghai Institute of Acupuncture, Moxibustion and Meridian:
Urgency-frequency Syndrome
Electrical Pudendal Nerve Stimulation
Tolterodine Tartrate

Additional relevant MeSH terms:
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Syndrome
Urinary Bladder, Overactive
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents