Overactive Bladder SyndromeNCT06088394
Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder
A study testing Acupuncture and pelvic floor exercises in people with Overactive Bladder Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Acupuncture and pelvic floor exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Oct 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a clinical diagnosis of idiopathic OAB syndrome. Willingness to take part in the study protocol. Ability to complete outcome measures. Ability to give informed consent. Acupuncture not contra-indicated. Age:50-60 years. Vaginal delivery.
- -Parity:2-3times. Body mass index <35kg/m2.
Who cannot join
- - Evidence of other pathology that may be contributing to OAB symptoms i.e., urinary tract infection or a neurological condition.
- Smoking.
- Taking sedative and hypnotic drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza, 12611
Rana Ahmed, master, 01094761174, ranaahmedmohamed35@gmail.com
About this study
Official title: Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder
The aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder
Read the detailed description
Overactive bladder syndrome (OAB) is a common complaint affecting 11.8% of the population. OAB is defined by the International Continence Society as "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology."Urinary frequency accompanies OAB in 20%-25% of cases, and nocturia is present in 70%-75% of cases. Around one in three people with OAB also experience urinary incontinence. . OAB can be further categorized into "OAB-dry" (urinary incontinence is absent) and "OAB-wet" (urinary incontinence is present). 2 OAB is a long-term condition that reduces quality of life, leading to anxiety and depression and a negative effect on self-esteem.
Pelvic floor exercises and acupuncture play an important role in overactive bladder.This trial has 2 groupes ,one will recieve pelvic floor exercises augmented with acupuncture ,the second will recive pelvic floor exercises only for 12weeks.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Acupuncture, pelvic floor exercises
- Keywords
- pelvic floor exercises and acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Participants will be asked to assume supine lying position on the plinth and the following points will be located then needles will be inserted:
- CV3,4 \&5-40 mm needles at a depth of 1 cun perpendicular insertion.
- ST 25 bilaterally-40 mm needles at a depth of 1 cun oblique insertion.
- SP6 \& 9, K13\&7 bilaterally-25 mm needles at a depth of 0.5 cun perpendicular insertion. A total of 13 needles will be inserted at each session.
pelvic floor exercisesOther
pelvic floor muscle exercises can help strengthen pelvic floor muscle, which provides better control of urinary urgency by interfering with urethral-detrusor reflexes and inhibiting detrusor contractions
| Study group | Role | What they receive |
|---|---|---|
| The patients will do pelvic floor exercises and acupuncture | Experimental | The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks Receives: Device: Acupuncture; Other: pelvic floor exercises |
| The patient will do pelvic floor exercises | Experimental | The patient will perform pelvic floor exercises 3 times per week for 12 weeks. pelvic floor muscles exercises involves repetitive contraction and relaxation of the pelvic floor muscles in an attempt to strengthen the muscles .
Each training session involved three training rounds and each round lasted for five minutes. Women will be instructed to perform PFMC and rest with 10min break between each round. They will be instructed to perform two to three sets of PFE repetitions per day, with 8-10 PFMC lasting for 10 s each set. All women will be asked to document their practice of PFE in PFE diary to assess their compliance. Receives: Other: pelvic floor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oxford scale
The scale ranges from 0 to 5 ranging from "no contraction" to "maximal contraction which is assessed by digital palpation using 1 to 2 fingers inserted into the vagina or rectum . This method is reliable to assess improvements in overall function and voluntary control of the PFM necessary for proper voiding
Measured: 12 weeks
Secondary outcomes (1)
patient perception of intensity and urgency scale (PPIUS)
A 5-point scale designed for measurement of both urinary urgency and urge incontinence. It has been incorporated into a micturition diary and has been used in OAB clinical trials
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start13 Oct 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pelvic floor exercises and acupuncture
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ahmed Elsayed, Cairo University
- Investigators
- cairo U Egypt, Study chair, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088394
- Sponsor's protocol ID
- P.T.REC/012/004593
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder
- ClinicalTrials.gov ID
- NCT06088394
- Acronym / sponsor ID
- P.T.REC/012/004593
- Conditions
- Overactive Bladder Syndrome
- Keywords
- pelvic floor exercises and acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Oct 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder
Detailed description
Overactive bladder syndrome (OAB) is a common complaint affecting 11.8% of the population. OAB is defined by the International Continence Society as "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology."Urinary frequency accompanies OAB in 20%-25% of cases, and nocturia is present in 70%-75% of cases. Around one in three people with OAB also experience urinary incontinence. . OAB can be further categorized into "OAB-dry" (urinary incontinence is absent) and "OAB-wet" (urinary incontinence is present). 2 OAB is a long-term condition that reduces quality of life, leading to anxiety and depression and a negative effect on self-esteem.
Pelvic floor exercises and acupuncture play an important role in overactive bladder.This trial has 2 groupes ,one will recieve pelvic floor exercises augmented with acupuncture ,the second will recive pelvic floor exercises only for 12weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- pelvic floor exercises and acupuncture
| Arm | Type | Receives |
|---|---|---|
| The patients will do pelvic floor exercises and acupuncture | Experimental | Device: Acupuncture, Other: pelvic floor exercisesThe patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks |
| The patient will do pelvic floor exercises | Experimental | Other: pelvic floor exercisesThe patient will perform pelvic floor exercises 3 times per week for 12 weeks. pelvic floor muscles exercises involves repetitive contraction and relaxation of the pelvic floor muscles in an attempt to strengthen the muscles . Each training session involved three training rounds and each round lasted for five minutes. Women will be instructed to perform PFMC and rest with 10min break between each round. They will be instructed to perform two to three sets of PFE repetitions per day, with 8-10 PFMC lasting for 10 s each set. All women will be asked to document their practice of PFE in PFE diary to assess their compliance. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of idiopathic OAB syndrome. Willingness to take part in the study protocol. Ability to complete outcome measures. Ability to give informed consent. Acupuncture not contra-indicated. Age:50-60 years. Vaginal delivery.
- -Parity:2-3times. Body mass index <35kg/m2.
Key exclusion criteria (3 listed)
- - Evidence of other pathology that may be contributing to OAB symptoms i.e., urinary tract infection or a neurological condition.
- Smoking.
- Taking sedative and hypnotic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureParticipants will be asked to assume supine lying position on the plinth and the following points will be located then needles will be inserted: * CV3,4 \&5-40 mm needles at a depth of 1 cun perpendicular insertion. * ST 25 bilaterally-40 mm needles at a depth of 1 cun oblique insertion. * SP6 \& 9, K13\&7 bilaterally-25 mm needles at a depth of 0.5 cun perpendicular insertion. A total of 13 needles will be inserted at each session. | Device | The patients will do pelvic floor exercises and acupuncture |
| pelvic floor exercisespelvic floor muscle exercises can help strengthen pelvic floor muscle, which provides better control of urinary urgency by interfering with urethral-detrusor reflexes and inhibiting detrusor contractions | Other | The patient will do pelvic floor exercises, The patients will do pelvic floor exercises and acupuncture |
Primary outcome
Modified Oxford scale
Time frame: 12 weeks
The scale ranges from 0 to 5 ranging from "no contraction" to "maximal contraction which is assessed by digital palpation using 1 to 2 fingers inserted into the vagina or rectum . This method is reliable to assess improvements in overall function and voluntary control of the PFM necessary for proper voiding
1 secondary outcome
patient perception of intensity and urgency scale (PPIUS)
Time frame: 12 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cairo U Egypt study chair
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and pelvic floor exercises in people with Overactive Bladder Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Ahmed, Master (0201094761174, ranaahmedmohamed35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Oxford scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.