Non-Specific UrethritisNCT05399173
Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females
A study testing infrared (gallium aluminum arsenide laser) and medical treatment(desmopressin acetate) in people with Non-Specific Urethritis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of laser acupuncture on monosymptomatic nocturnal enuresis in adolescent females. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women only
- Conditions the study is for
- Non-Specific Urethritis
- What is being tested?
- infrared (gallium aluminum arsenide laser) and medical treatment(desmopressin acetate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2022to 8 Sep 2023
- 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 10 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent females have to meet the following criteria in order to participate in this study:
- Suffering from Monosymptomatic nocturnal enuresis.
- Their ages will range from 10-18 years.
- Resistance to medical treatment (desmopressin acetate)
Who cannot join
- Adolescent Females with the following criteria will be excluded from this study:
- Psychological or neurological disorders or other organic disorders.
- Any chronic diseases.
- Spinal cord abnormalities associated neurogenic bladder.
- Evidence of urinary tract infection.
- Ectopic ureter In addition, chronic constipation or encopresis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza
Jehan Mustafa, Master, 01063299714, jejemustafa@gmail.com
About this study
The aim of this study is to evaluate the effect of laser acupuncture on monosymptomatic nocturnal enuresis in adolescent females.
Read the detailed description
Nocturnal enuresis (NE) can be defined as the involuntary passage of urine during sleep beyond the age of anticipated nighttime bladder control, which is generally accepted as 5 years of age.
IF neglected may persist into adulthood and be associated with urgency incontinence . It causes social, psychological, and emotional distress and carries a significant clinical burden. Studies show that enuretic children have lower self-esteem than healthy children. Even among chronic illnesses, enuresis has more negative effect on children's mental and social health .
Most of the studies highlighted that persisting NE was a high risk of psychosocial comorbidity and negatively affects the quality of life. The feeling of helplessness of enuretic patients highlights the magnitude and complexity of the problem. Persisting enuresis adversely affects the coping, social competence, and school performance of enuretic patients when compared to their normal peers. Furthermore, a negative correlation exists between the self-esteem of an enuretic child and the chance of treatment failure .
Complementary and alternative medicine (CAM) widely helped to encounter the increasing demand for non-pharmacological approaches. In recent years, there is a focus on finding cost-effective therapeutic approaches with minimal side effects to treat nocturnal enuresis .
Regarding the effect of laser acupuncture on nocturnal enuresis, previous studies about the effect of low level laser acupuncture on monosymptomatic nocturnal enuresis females are limited. There was only one previous study that examined the effect of low level laser acupuncture on bladder reservoir . This study will be the first one to objectively assess the effect of laser acupuncture in monosymptomatic nocturnal enuresis by sonography. As a result, this study will have variable benefits for medical care organizations and will add to the body of knowledge of physical therapists in the scientific domain. Control group will consist of 30 females. participants will receive medical treatment (desmopressin acetate, ) per-night dose of 120 g (for 6 weeks) \& advice .
Study group will consist of 30 females. participants will receive the same medical treatment and advice as in group (A) in addition to low level laser therapy 3 session / week for 6 weeks.
All participants will be given a full explanation of the protocol of the study and an informed consent form will be signed by each female before participating in the study .
- Conditions
- Non-Specific Urethritis
- Being tested
- infrared (gallium aluminum arsenide laser), medical treatment(desmopressin acetate)
- Keywords
- adolescents, nocturnal enuresis
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared (gallium aluminum arsenide laser)Device
Patient Position will be in supine \& prone position, the area of these points is resolved utilizing anatomical landmarks and an arrangement of length measurements whose units are in respect to the physical extents of the individual patient. Acupuncture points used to treat nighttime enuresis are situated in regions that coincide with innervation by spinal sacral segments S2 through to S4 and expressed in the treatment conventions. The points of BL 23, BL 28, BL 32, RN 3, RN 4, RN 6, RN 12 impact the spinal micturition centers and parasympathetic innervation to the urinary tract, while excitement on scalp acupoints of DU 20 and DU 14 change cerebrum function through inner temporal, thalamencephalon and prefrontal cortical frameworks. Excitation of acupoints UB 20, UB 13, SP 6, ST 36, KI 3 and LU 9 are considered to strengthen spleen, vital energy and blood which encourage standardized bladder capacity
medical treatment(desmopressin acetate)Drug
participants will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) \& advice
| Study group | Role | What they receive |
|---|---|---|
| an infrared (gallium aluminum arsenide laser) | Experimental | Each female in study group will be treated by laser acupuncture for 3 sessions per week, for 6 weeks. An infrared (gallium aluminum arsenide) laser will be used at a wavelength of 808 nm and a power of 200 m W applied for 26 s to produce energy of less than 4 J/cm. participants will receive the same medical treatment (desmopressin acetate) and advice as in control group in addition to low level laser therapy 3 session / week for 6 weeks. Receives: Device: infrared (gallium aluminum arsenide laser) |
| conventional therapy | Active comparator | They will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) \& advice. Receives: Drug: medical treatment(desmopressin acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder capacity
Sonography for bladder capacity. It will be used to determine bladder capacity for all participants before the beginning of the study for both groups, and at end of the study
Measured: up to 6 weeks
Secondary outcomes (2)
Maximum voided volume
will be measured in all participants. using a voiding diary over 4 days before starting therapy for each female in both group A and B and after the treatment program.
Measured: up to 6 weeks
Frequency of bed wet
It will be used to determine the number of bed wet for each female in both group A and B before and after the treatment program.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start2 Jun 2022
- Primary completion8 Sep 2023 (estimated)
- Study completion8 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Specific UrethritisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jehan Hussien Mohammed Mustafa, Cairo University
- Investigators
- Mai Mo Shehata, lecturer, Principal investigator, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399173
- Sponsor's protocol ID
- P.T.REC/012/003689
- Status last verified
- Aug 2023
- First submitted
- 23 May 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture for Treating Monosymptomatic Nocturnal Enuresis in Adolescent Females
- ClinicalTrials.gov ID
- NCT05399173
- Acronym / sponsor ID
- P.T.REC/012/003689
- Conditions
- Non-Specific Urethritis
- Keywords
- adolescents, nocturnal enuresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 8 Sep 2023 (estimated)
- Study completion
- 8 Sep 2023 (estimated)
- First posted
- 1 Jun 2022 (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 evaluate the effect of laser acupuncture on monosymptomatic nocturnal enuresis in adolescent females.
Detailed description
Nocturnal enuresis (NE) can be defined as the involuntary passage of urine during sleep beyond the age of anticipated nighttime bladder control, which is generally accepted as 5 years of age.
IF neglected may persist into adulthood and be associated with urgency incontinence . It causes social, psychological, and emotional distress and carries a significant clinical burden. Studies show that enuretic children have lower self-esteem than healthy children. Even among chronic illnesses, enuresis has more negative effect on children's mental and social health .
Most of the studies highlighted that persisting NE was a high risk of psychosocial comorbidity and negatively affects the quality of life. The feeling of helplessness of enuretic patients highlights the magnitude and complexity of the problem. Persisting enuresis adversely affects the coping, social competence, and school performance of enuretic patients when compared to their normal peers. Furthermore, a negative correlation exists between the self-esteem of an enuretic child and the chance of treatment failure .
Complementary and alternative medicine (CAM) widely helped to encounter the increasing demand for non-pharmacological approaches. In recent years, there is a focus on finding cost-effective therapeutic approaches with minimal side effects to treat nocturnal enuresis .
Regarding the effect of laser acupuncture on nocturnal enuresis, previous studies about the effect of low level laser acupuncture on monosymptomatic nocturnal enuresis females are limited. There was only one previous study that examined the effect of low level laser acupuncture on bladder reservoir . This study will be the first one to objectively assess the effect of laser acupuncture in monosymptomatic nocturnal enuresis by sonography. As a result, this study will have variable benefits for medical care organizations and will add to the body of knowledge of physical therapists in the scientific domain. Control group will consist of 30 females. participants will receive medical treatment (desmopressin acetate, ) per-night dose of 120 g (for 6 weeks) \& advice .
Study group will consist of 30 females. participants will receive the same medical treatment and advice as in group (A) in addition to low level laser therapy 3 session / week for 6 weeks.
All participants will be given a full explanation of the protocol of the study and an informed consent form will be signed by each female before participating in the study .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| an infrared (gallium aluminum arsenide laser) | Experimental | Device: infrared (gallium aluminum arsenide laser)Each female in study group will be treated by laser acupuncture for 3 sessions per week, for 6 weeks. An infrared (gallium aluminum arsenide) laser will be used at a wavelength of 808 nm and a power of 200 m W applied for 26 s to produce energy of less than 4 J/cm. participants will receive the same medical treatment (desmopressin acetate) and advice as in control group in addition to low level laser therapy 3 session / week for 6 weeks. |
| conventional therapy | Active comparator | Drug: medical treatment(desmopressin acetate)They will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) \& advice. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent females have to meet the following criteria in order to participate in this study:
Key exclusion criteria (6 listed)
- Adolescent Females with the following criteria will be excluded from this study:
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 |
|---|---|---|
| infrared (gallium aluminum arsenide laser)Patient Position will be in supine \& prone position, the area of these points is resolved utilizing anatomical landmarks and an arrangement of length measurements whose units are in respect to the physical extents of the individual patient. Acupuncture points used to treat nighttime enuresis are situated in regions that coincide with innervation by spinal sacral segments S2 through to S4 and expressed in the treatment conventions. The points of BL 23, BL 28, BL 32, RN 3, RN 4, RN 6, RN 12 impact the spinal micturition centers and parasympathetic innervation to the urinary tract, while excitement on scalp acupoints of DU 20 and DU 14 change cerebrum function through inner temporal, thalamencephalon and prefrontal cortical frameworks. Excitation of acupoints UB 20, UB 13, SP 6, ST 36, KI 3 and LU 9 are considered to strengthen spleen, vital energy and blood which encourage standardized bladder capacity | Device | an infrared (gallium aluminum arsenide laser) |
| medical treatment(desmopressin acetate)participants will receive medical treatment (desmopressin acetate) per-night dose of 120 g (for 6 weeks) \& advice | Drug | conventional therapy |
Primary outcome
bladder capacity
Time frame: up to 6 weeks
Sonography for bladder capacity. It will be used to determine bladder capacity for all participants before the beginning of the study for both groups, and at end of the study
2 secondary outcomes
Maximum voided volume
Time frame: up to 6 weeks
Frequency of bed wet
Time frame: up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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.
Mai Mo Shehata, lecturer principal investigator
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 infrared (gallium aluminum arsenide laser) and medical treatment(desmopressin acetate) in people with Non-Specific Urethritis, 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 4 inclusion and 6 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 30 Aug 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 Jehan Hu Mustafa, demonstrator (01063299714, jejemustafa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder capacity (time frame: up to 6 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 30 Aug 2023.