Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911868991836 Date of Approval: 29/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF TRANSCUTANEOUS VERSUS PERCUTANEOUS TIBIAL NERVE STIMULATION ON OVER ACTIVE BLADDER IN POST MENOPAUSAL WOMEN
Official scientific title EFFECT OF TRANSCUTANEOUS VERSUS PERCUTANEOUS TIBIAL NERVE STIMULATION ON OVER ACTIVE BLADDER IN POST MENOPAUSAL WOMEN
Brief summary describing the background and objectives of the trial The purpose of this study is to: 1) determine the effect of transcutaneous and percutaneous tibial nerve stimulation on post-menopausal women with over active bladder; 2) compare the effect of transcutaneous versus percutaneous tibial nerve stimulation on post-menopausal women with over active bladder.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial TRANSCUTANEOUS VERSUS PERCUTANEOUS TIBIAL NERVE STIMULATION ON OVER ACTIVE BLADDER
Anticipated trial start date 26/11/2019
Actual trial start date 27/11/2019
Anticipated date of last follow up 26/05/2020
Actual Last follow-up date 26/05/2020
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group anti muscarinic drugs (5-10mg)per day for 12 weeks -Each woman in all groups (A,B&C) will receive selective anti muscarinic drugs (5-10mg)per day. 20 Active-Treatment of Control Group
Experimental Group Transcutaneous tibial nerve stimulation 3 times/week for 12 weeks -Each woman in group (B) will receive transcutaneous tibial nerve stimulation as follows: -The electrodes will be placed as follows: the negative electrode on the medial ankle malleolus, and the positive electrode 10 cm proximal to this, on the right leg along the nerve path. -Both electrodes will be connected to a conventional electrical stimulator producing pulses ranging from 10 to 50 mA (according to sensitivity and hallux mobilization of the patient during the therapy). -All women will show some degree of hallux mobilization (stimulation of the big toe), which ensures that the tibial nerve will be stimulated. Each session will last 30 min, with a pulse duration of 200 ms and frequency of 10 Hz in continuous mode. It will be applied 3 times/week for 12 weeks 20
Experimental Group Percutaneous tibial nerve stimulation 3 times/week for 12 weeks Each woman in group (C) will receive percutaneous tibial nerve stimulation as follows: -The procedures consist of stimulation of the tibial nerve by 34 gauge needle electrode inserted 4–5 cm cephalad to the medial malleolus. Interestingly, this site is the same one used in traditional Chinese acupuncture (spleen 6) to relieve dysfunction of the pelvic floor and pelvic organs. - Each woman will be positioned either supine or sitting with the soles of the feet together and their knees abducted and flexed (“frog position”). A pad will be placed at the medial face of the ipsilateral calcaneus as grounding. -The needle electrode will be connected to an external low voltage (9 V) pulse generator, which will deliver the electrical pulse. Once the electrode needle will be correctly placed and pulse will be applied, woman’s response will be confirmed by involuntary toe flexion of the entire foot accompanied by a sensation in the ankle and sole of the foot. Toe flexion will occur from direct stimulation of the S3 nerve root, which will be also responsible for bladder innervation. -A current level of 0.5-9 mA at a fixed frequency of 20 Hz and pulse width of 200 μs will be selected and adjusted based on the woman’s tolerance to the associated discomfort. Commonly used protocol consists of 3 times /week lasting approximately 30 minutes for 12 weeks 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Post-menopausal women suffering from pure urge urinary incontinence. • Their age will range from 55-65 years old. • Their body mass index (BMI) will range from 25-29.9 kg/m2. • They will experience menopause at least for 3 years. Post-menopausal women will be excluded if they had: • Urinary tract infection • Previous surgery for urinary incontinence • Upper motor neuron diseases • History of genito-urinary cancer • Previous pelvic irradiation • Pure stress urinary incontinence • Genital prolapse • Diabetes mellitus • Pace maker • Metal implantation. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 55 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/11/2019 Research Ethics committee Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmed El-Zayyat Dokki, Giza, Egypt 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 3-Day Bladder diary. It will be used to record the number of voids and number of incontinent episodes per day for each woman in all groups At baseline and after 3 months
Primary Outcome Pad test. It will be used to confirm and quantify the urine leakage for each woman in all groups (A,B&C). It is a simple noninvasive inexpensive, and easy method to evaluate the effect of treatment modalities for incontinence. Long duration (24 to 48 hours) pad test will be used At baseline and after 3 months
Primary Outcome Urodynamic Investigation System. It will also be used to measure the volume at first desire to void, first sensation of bladder filling (1st SBF) during cystometry, and maximum bladder capacity (MBC). At baseline and after 3 months
Secondary Outcome Overactive Bladder questionnaire Short Form (OAB-q SF): It will be used to assess symptoms and health-related quality of life (HR-QOL) for each woman in all groups (A,B&C). It is a brief, self-administered patient-reported outcomes tool with two scales. It is internally consistent, valid, and responsive to treatment-related change. At baseline and after 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AlAzhar Hospital Alazhar street New Damietta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Khaled Sayed Ahmed International Coastal Road New Damietta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University Ahmed Elzayat Street Dokki 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
SALWA MOSTAFA EL BADRY Ahmed Elzayyat Dokki Egypt
ABEER MOHAMED ELDEEB Ahmed Elzayyat Dokki Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Sayed ksayed@horus.edu.eg +201003895122 International Coastal road
City Postal code Country Position/Affiliation
New Damietta Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries SALWA EL BADRY elbadry_s@yahoo.com +201001412962 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
Dokki Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries ABEER ELDEEB beroeldeeb@yahoo.com +201001811588 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
Dokki Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Sixty post-menopausal women suffering from overactive bladder will participate in this study. They will be selected from Al-Azhar Hospital, New Damietta City. Data collected from this study, including de-identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12 months of publication of the primary outcomes of the study. Using of controlled access approach with systems in place to review data access requests for the medical community. Data will be made available as soon as possible after request approval on secure server or other secure data transfer methods. Supporting documentation will be supplied with the data set.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information