Tibial nerve stimulation for overactive bladder

• Register: ISRCTN
• Last refreshed on: 26 July 2021
• Main ID: ISRCTN15733799
• Date of registration: 30/01/2018
• Prospective Registration: No
• Primary sponsor: Centro de Urología Avanzada CURA
• Public title: Tibial nerve stimulation for overactive bladder
• Scientific title: Percutaneous Tibial Nerve Stimulation (PTNS) for patients with overactive bladder syndrome: effect of number of sessions and gender
• Date of first enrolment: 01/01/2016
• Target sample size: 80
• URL: https://www.isrctn.com/ISRCTN15733799
• Study type: Interventional
• Study design: Longitudinal random consecutive case controlled study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Mexico

Contacts

• Name: Carlos Perez-Martinez

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adults (female and male) suffering refractory OAB syndrome, 8 or more micturitions in 24 hours and questionnaire OAB-q SF score = 20 points
2. No response to medication
3. Evolution time = 6 months
4. Agree to participate and sign informed consent

Exclusion criteria:
1. Urinary tract infection
2. History of congenital urogenital disease, radiation, bladder cancer or litiasis
3. People who can not participate because of religious, cultural or mental reasons
4. People who can not participate because of do not sign informed consent or unwilling to participate in the protocol
5. Pregnancy
6. Age less than 18 years old
7. History of taking OAB medication for less than 2 weeks before to start PTNS


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Over active bladder syndrome
Urological and Genital Diseases
Over active bladder syndrome

Intervention(s)

Participants are recruiting in accordance the inclusion criteria and provide consent to participate in the protocol.

Data is collected about age, evolution time, voiding diary, OABq-SD questionnaire (Part A) using an Excel database, and values processed using the statistical software SPSS 10. Participants are then non-randomly allocated to groups based on experiment design and sample size. Participants are allocated to one of three groups. Participants with a severe impact on their quality of life are not included in placebo group. Participants are blinded to which group they are allocated to.

Group 1:
Participants receive a percutaneous tibial nerve stimulation (PTNS) session. The PTNS procedure consists of using a 34 gauge needle electrode inserted at a 60 degree angle, 3 to 4 cm deep 34 gauge needle electrode inserted at a 60 degree angle, 3 to 4 cm deep, in a point approximately 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. The device used is a Neuromuscular Electrostimulator EMS+2, STAODYN, (Staodyn, Inc, Longmont). Data is collected before and 24 hours after (PTNS) 30 minutes single session and is also again collected one, three and six months after the session.

Group 2:
Participants receive six 30 minute sessions of PTNS over a two week period (three sessions each week). Data is collected before the PTNS session (3 per week) and is also collected one, three and six months after.

Group 3 (Placebo group):
Participants receive the one 30 minute session of the placebo PTNS. This consists of using a 34 gauge needle electrode inserted at a 60 degree angle, only 2mm deep, 34 gauge needle electrode inserted a

Primary Outcome(s)

Bladder activity (nocturia, incontinence or urgency and frequency)is measured using the patient diaries for Group 1 and Placebo Group at baseline, 24 hours, one, three and six months and for Group 2 at baseline, one, three and six months.

Secondary Outcome(s)

1. Overactive bladder symptoms are measured using OABq-SF Questionnaire Part A for Group 1 and Placebo Group at baseline, 24 hours, one, three and six months and for Group 2 at baseline, one, three and six months.
2. Overactive bladder symptoms are measured using Perception of Bladder Condition (PPBC) Questionaire for Group 1 and Placebo Group at baseline, 24 hours, one, three and six months and for Group 2 at baseline, one, three and six months

Secondary ID(s)

PTNS2016SHORT

Source(s) of Monetary Support

Lito Movil del Norte SA de CV, Centro de Urología Avanzada (CURA)

Ethics review

Status:
Approval date:
Contact:

Ethical Committee of Litomovil del Norte/Urological Avaced Center, 30/11/2015, ref: PTNS2016SHORT-30/11/2015

Results

• Results available: Yes
• Date Completed: 30/06/2020