Clinical trial NCT06662565: Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder
Official title: Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder

Detailed description: The relationship between overactive bladder (OAB), constipation, and overactive pelvic floor muscles is complex and interrelated. OAB increases the likelihood of overactive pelvic floor muscles, and conversely, hyperactive pelvic floor muscles can exacerbate OAB symptoms. Non-relaxing pelvic floor dysfunction often presents with urinary symptoms, including increased frequency, hesitancy, urgency, dysuria, bladder pain, and occasionally urge incontinence Pelvic floor down-training exercises targeting the rectum provide a safe, conservative way to manage constipation, which may in turn help relieve OAB. Unlike medications or surgery; these exercises are generally safe and easy to incorporate into daily life. However, more studies are needed to evaluate their effectiveness, especially for treating idiopathic OAB in women. Filling this research gap will provide clearer clinical guidance on managing the interplay between OAB, constipation, and pelvic floor hyperactivity. So this study will be the first to investigate the effect of pelvic floor down-training on symptoms of idiopathic OAB in women.

Eligibility criteria: Inclusion Criteria:

* Multiparous woman with idiopathic OAB (2-3 times) who diagnosed by physician and confirmed by the urodynamic study.
* Woman with high rectal resting tone measured by pressure biofeedback.
* Woman diagnosed with constipation according to the Rome IV criteria and Bristol score.
* Ages ranging from 30 to 45 years.
* BMI from 25-29.9 Kg/m2

Exclusion Criteria:

Women will be excluded from the study if they have:

* Severe OAB as measured by the overactive bladder symptom score for severity
* Postmenopausal women (a point in time 12 months after a woman's last period.)
* Any abnormalities around the bladder, such as bladder cancer, bladder calculus, interstitial cystitis, or endometriosis.
* Untreated urinary tract infections.
* Psychological or mental health problems.
* Pregnancy and lactation
* A history of previous pelvic surgery.
* Are receiving any pharmacological treatment at the time of the study.

Primary outcomes:
measure: Rectal resting pressure
timeFrame: 8 weeks
measure: Rectal bearing pressure
timeFrame: 8 weeks
measure: Overactive Bladder Symptom Score (OABSS):
timeFrame: 8 weeks
measure: Assessment of overactive bladder symptoms
timeFrame: 8 weeks
measure: Assessment of quality of life
timeFrame: 8 weeks
measure: Constipation scoring system
timeFrame: 8 weeks
measure: Five-item score for obstructed defecation syndrome (ODS-S)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ayatullah Farouk Abdel Fattah
Study officials:
affiliation: Cairo University
name: Amira N. Abdel Latif, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Doaa A. Osman, professor
role: STUDY_CHAIR
References: