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

NCT02723279 | Completed DMC

• 1 other identifier: 201512ZYSUFS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Urgency-frequency Syndrome

Keywords

Urgency-frequency Syndrome; Electrical Pudendal Nerve Stimulation; Tolterodine Tartrate

Outcome Measures

Primary Outcomes (2)

• Lower urinary tract syndrome score

  International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) is used

  6 weeks

• Quality of life score

  International Consultation on Incontinence Questionnaire-Quality of life (ICIQ-qol) is used

  6 weeks

Study Arms (2)

EPNS group

EXPERIMENTAL

Behavioral: EPNS

TT group

ACTIVE COMPARATOR

Drug: TT

Interventions

EPNS BEHAVIORAL

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.

Also known as: electrical pudendal nerve stimulation

EPNS group

TT DRUG

Tolterodine tartrate (GSK， UK) 4mg per day is taken orally for six weeks

Also known as: Tolterodine tartrate

TT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• RenJi Hospital: collaborator

Study Sites (1)

Shanghai research institute of acupuncture and meridian

Shanghai, 200030, China

Location

MeSH Terms

Interventions

Tolterodine Tartrate

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Siyou Wang

  Shanghai University of Traditional Chinese Medicine affliated Yueyang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

CN (1)