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Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder

Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06088394
Enrollment
40
Registered
2023-10-18
Start date
2023-10-13
Completion date
2024-02-01
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome

Keywords

pelvic floor exercises and acupuncture

Brief summary

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.

Interventions

DEVICEAcupuncture

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 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

random generator

Intervention model description

pelvic floor exercises and acupuncture

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

* \- 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.

Design outcomes

Primary

MeasureTime frameDescription
Modified Oxford scale12 weeksThe 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

Secondary

MeasureTime frameDescription
patient perception of intensity and urgency scale (PPIUS)12 WEEKSA 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

Other

MeasureTime frameDescription
8 Items overative bladder questionnaire12 weeks: The OAB-V8 asks how bothered one is by the 4 hallmark symptoms of OAB: urinary frequency, urgency, nocturia, and urge incontinence Patients respond on a 6-point Likert scale ranging from 0 (not at all) to 5 (a very great deal), with a maximum possible score of 40. After completing the awareness tool, patients were asked to calculate their scores by adding their responses .
3days bladder diary test12 weeksIt consists of three sheets to be completed by the patient (one for each day) and one evaluation sheet to be completed by the clinician based on the interpretation of the three patient-completed sheets. The patient should record, on the daily sheet, the time they wake up and go to bed and the time and volume of every micturition.

Countries

Egypt

Contacts

Primary ContactRana Ahmed, Master
ranaahmedmohamed35@gmail.com0201094761174
Backup ContactRana Ahmed, Master
ranaahmedmohamed35@gmail.com01094761174

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026