Condition category
Urological and Genital Diseases
Date applied
09/01/2018
Date assigned
30/01/2018
Last edited
02/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The overactive bladder affects 4 out of 10 people, causing a huge economic burden and severely affects daily life. This medical condition impairs the quality of life of people as it causes sudden urges to urinate and involuntary loss of urine. Medications are the most used treatment but they have several adverse effects. There is new technology named neuromodulation (stimulating nerve activity) that may have a better impact on overactive bladders with no medical risks and a longer lasting impact. One of this technique called Tibial Nerve Stimulation which uses punctures in the leg in certain points specified by Chinese acupuncture called Splen-6 or Sanyinjiao. This procedure is painless, fast and has success in 60.6% of people, lasting as long as 24 months, with minimum adverse effects. The aim of this study is to evaluate the effects of a short number of sessions of Tibial Nerve Stimulation in persons who are suffering of overactive bladder.

Who can participate?
Adults over 18 years and older who are suffering overactive bladder

What does the study involve?
Participants are assigned to one of three groups. Those in the first group receive a single session of PTNS. Those in the second group perceive six sessions of PTNS over a two week period. Those in the last group receive a single dummy PTNS. Participants are followed for six 6 months. Each participant is asked to keep diaries documenting how many times they experience overactive bladder symptoms to assess the impact of their condition.

What are the possible benefits and risks of participating?
Participant may benefit from having the treatment for free, a no charge medical consultation and from having 24 hour access by phone to a Doctor. The participants who have the treatment have the possibility to reduce their symptoms in at least 60%. The risks are minimal like small pain or bleeding in the point of puncture as the procedure is painless.

Where is the study run from?
Centro de Urología Avanzada CURA (Mexico)

When is the study starting and how long is it expected to run for?
Janaur y2015 to December 2019

Who is funding the study?
Litomovil del Norte SA de CV/ Centro de Urología Avanzada CURA (Mexico)

Who is the main contact?
Carlos Pérez-Martínez MD
cperez4351@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlos Perez-Martinez

ORCID ID

Contact details

Centro de Urología Avnzada CURA
Avenida Agricultura Poniente 514
Colonia Centro
Delicias
Chihuahua
33000
Mexico
+52 (0)6394725206
cperez4351@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PTNS2016SHORT

Study information

Scientific title

Percutaneous Tibial Nerve Stimulation (PTNS) for patients with overactive bladder syndrome: effect of number of sessions and gender

Acronym

PTNS2016SHORT

Study hypothesis

The effect of Percutaneous Tibial Nerve Stimulation (PTNS) in overactive bladder (OAB) syndrome patients depends of the number of session and the gender of the participant.

Ethics approval

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

Study design

Longitudinal random consecutive case controlled study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Over active bladder syndrome

Intervention

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 pecutaneour 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 cms deep 34 gauge needle electrode inserted at a 60 degree angle, 3 to 4 cms 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 at a 60 degree angle, 3 to 4 cms deep, in a point approximately 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. The device is turned on but the electrode is disconnected. Data is collected before and 24 hours after the session and again at one, three and 6 months later.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

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 measures

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

Overall trial start date

01/02/2015

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 Partricipants: Placebo 20; Group I 20; Group II 20; Group III 20 volunteers;

Participant 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

Recruitment start date

01/01/2016

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Mexico

Trial participating centre

Centro de Urología Avanzada CURA
Av. Agricultura Poniente 514, Colonia Centro.
Delicias
33000
Mexico

Sponsor information

Organisation

Centro de Urología Avnzada CURA

Sponsor details

Avenida Agricultura Poniente 514
Colonia Centro
Delicias
Chihuahua
33000
Mexico
+52 (0)6394743676
cperez4351@hotmail.com

Sponsor type

Hospital/treatment centre

Website

http://centrodeurologiaavanzada.com.mx

Funders

Funder type

Hospital/treatment centre

Funder name

Litomovil del Norte SA de CV/ Centro de Urología Avanzada CURA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be done by groups. 1st group results by June 2018, 2nd group results by Dec 2018, 3rd group results by June 2019.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from:
Carlos Pérez-Martínez MD
cperez4351@hotmail.com

Intention to publish date

01/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/02/2018: Internal review.