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Transcutaneous Posterior Tibial Nerve Electrostimulation With Low Dose Trospium Chloride in OAB in Females

A

Alexandria University

Status

Completed

Conditions

Overactive Bladder

Treatments

Device: TPTNS
Combination Product: TPTNS+Drug

Study type

Interventional

Funder types

Other

Identifiers

NCT03104101
Alexandria University

Details and patient eligibility

About

This study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy.

Full description

The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30 minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.

Enrollment

30 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics

Exclusion criteria

  1. Patients having urinary tract infection or bladder outlet obstruction.
  2. Patients having neurological diseases.
  3. Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors.
  4. Patients with electronic implants such as heart pacemakers.
  5. During pregnancy
  6. Patients subject to seizures

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

TPTNS
Active Comparator group
Description:
Those who received Transcutaneous posterior tibial nerve stimulation sessions only
Treatment:
Device: TPTNS
TPTNS+Drug
Active Comparator group
Description:
Those who received Transcutaneous posterior tibial nerve stimulation sessions plus 20 mg Trospium chloride
Treatment:
Combination Product: TPTNS+Drug

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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