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.: PACTR202107816829078 Date of Approval: 29/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pelvic Floor Rehabilitation in Treatment of Mixed Urinary Incontinence Among Women
Official scientific title Pelvic Floor Rehabilitation in Treatment of Mixed Urinary Incontinence Among Women
Brief summary describing the background and objectives of the trial Mixed urinary incontinence (MUI) is a common under-reported problem among females, it has a major effect on patients’ quality of life (QOL). Treatment may be difficult since a single modality cannot be enough to alleviate both the urge and the stress symptoms. Biofeedback assisted pelvic floor muscle training (PFMT) has a great role in strengthening the pelvic floor muscles especially when accompanied by electrical stimulation. Neuromodulation is another safe well-tolerated method that may improve symptoms of female voiding dysfunction. There are no previous studies that assessed the efficacy of biofeedback PFMT versus two different types of peripheral neuromodulation which are TPTNS and anogenital neuromodulation in the treatment of MUI among women. The aim of this work is to study the effectiveness of biofeedback-assisted PFMT and electrostimulation versus peripheral neuromodulation in the treatment of MUI among women.
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 Treatment: Other
Anticipated trial start date 01/01/2020
Actual trial start date 01/01/2020
Anticipated date of last follow up 01/01/2021
Actual Last follow-up date 01/01/2021
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 68
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group posterior tibial neuromodulation 18 sessions / three times weekly (postponed during menstruation) 6- 8 weeks Patients in group II received 18 sessions of bilateral transcutaneous posterior tibial neuromodulation, the active rubber surface was placed behind the medial malleolus and the reference electrode was placed 10 cm proximal. Adjustment of the electric current was as follows: Continuous TENS current, pulse duration 200 msec. frequency 20 Hz, each session lasts for 30 minutes. The current intensity was adjusted according to the tolerance of the patient or until the big toe curls into plantarflexion 22
Control Group no control group none none 0 Uncontrolled
Experimental Group Anogenital neuromodulation 18 sessions / three times weekly 6-8 weeks ( postponed during menstruation ) Patients in group III were subjected to 18 sessions of anogenital vaginal electric stimulation using a vaginal stimulator and the same previous TENS current parameters. 23
Experimental Group biofeedback assisted pelvic floor muscle training with electrical stimulation 12 sessions / three times weekly 4-6 weeks (postponed during menstruation) - Surged triangular faradic stimulation for 15 minutes with 10 seconds holding time and 5 seconds interval. Pulse duration ranged from 0.1 to 1 ms. - Pressure biofeedback-assisted PFMT was done using a vaginal pressure sensor covered with a sterile latex glove, inserted in the vagina for 4 cm depth, and adjusting the pressure to zero level before starting the exercise. Strengthening exercise was performed by asking the patient to maximally contract her PFM for 5 seconds followed by relaxation for 10 seconds for 10 repetitions. Then a resting period for 3 – 4 minutes before starting the endurance exercise. Endurance exercise was done by asking the patient to sub-maximally contract her PFM (about 50% of maximal contraction pressure measured by the pressure manometry device) for one minute or for the maximum period that she could afford if less than one minute, followed by a resting period for one minute. This exercise was repeated also 10 times. The strength of PFM measured through the squeezing force in hectopascals (hPa), as well as the maximum duration of contraction was discussed with the patient each session to encourage her for better performance. Verbal encouragement response was given to the patient during performing the session. Visual and auditory clues were also provided to the patient as feedback to her PFM contraction 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Idiopathic mixed urinary incontinence age above 18-year-old Any patient had previous anorectal, genitourinary, and gynecological surgeries. Traumatic perineal injury History of radiotherapy. Patients consuming drugs that affect lower urinary tract function Patients with any neurological conditions that affect sphincteric function. Patients with urinary tract infection or vaginitis. Patients with implanted cardiac pacemaker and defibrillator. Patients with uncompensated heart disease or uncontrolled hypertension Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 22/02/2019 The Alexandria University Faculty of Medicine Review Board and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
alexandria alexandria 25700 Egypt
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 21/02/2019 The Alexandria University Faculty of Medicine Review Board and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine Alexandria 25700 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Subjective outcome measures (questionnaires) after completing the sessions
Secondary Outcome objective measures (clinical examination, manometric pressure measurements). by the end of sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
pelvic floor rehabilitation unit main university hospital alexandria alexandria 25700 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nehad Mohamed Elshatby Faculty of medicine Alexandria university 25700 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nehad Mohamed Elshatby Main university hospital -Alexandria university Alexandria 25700 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohamed Hassan Imam Faculty of medicine Alexandria 25700 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nehad Elshatby dr.nehad@yahoo.com +201090840279 Main university hospital
City Postal code Country Position/Affiliation
Alexandria 25700 Egypt Alexandria university
Role Name Email Phone Street address
Public Enquiries Marwa Hassan Marwa.hassan@alexmed.edu.eg +201002773457 Faculty of medicine
City Postal code Country Position/Affiliation
Alexandria 25700 Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Saba emadaziz55@yahoo.com +201224718376 Faculty of medicine
City Postal code Country Position/Affiliation
Alexandria 25700 Egypt Faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results reported in this article after deidentification including tables, figures, and appendicies Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol three years researchers who wish to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 29/07/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/07/2021 Result - 29/07/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information