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Effect of Pelvic Floor Down-training on Women With Idiopathic Overactive Bladder

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Overactive Bladder

Treatments

Behavioral: Behavioral modification
Other: Pelvic floor down-training

Study type

Interventional

Funder types

Other

Identifiers

NCT06662565
P.T.REC/012/005319

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

30 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Behavioral modification group
Active Comparator group
Description:
They will be treated with behavioral modification for 8 weeks.
Treatment:
Behavioral: Behavioral modification
Pelvic floor down training and behavioral modification group
Experimental group
Description:
They will be treated with the same behavioral modification plus pelvic floor down training three times per week for 24 sessions for 8 weeks.
Treatment:
Other: Pelvic floor down-training
Behavioral: Behavioral modification

Trial contacts and locations

1

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Central trial contact

Samer S. Mahmoud, PHD; Ayatullah F. Abdel Fattah, Master

Data sourced from clinicaltrials.gov

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