The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder

NCT04950556 | Unknown

• 1 other identifier: 2021/06/27
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study is to investigate the effects of pelvic floor muscle training (PFMT) on pelvic floor muscle strength, sexual functions, bladder symptoms and quality of life in women with overactive bladder (OAB).

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• Pelvic floor muscle strength

  The pelvic floor muscle strength of the patients will be evaluated by digital palpation. Change in pelvic floor muscle strength as measured with the Modified Oxford Scale, which ranges from 0 to 5

  change from baseline at 6 weeks

• Sexual Function

  Female sexual function will be assessed using the Female Sexual Function Index. This 19-question questionnaire deals with the subject in a multidimensional way by questioning the states of desire, arousal, lubrication, orgasm, satisfaction and pain. The highest raw score that can be obtained from the questionnaire is 95, and the lowest raw score is 4.

  change from baseline at 6 weeks

Secondary Outcomes (3)

• OAB symptoms

  change from baseline at 6 weeks

• Urinary frequency, nocturia and the number of urinary incontinence

  change from baseline at 6 weeks

• Life quality

  change from baseline at 6 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

Fast and slow contractions will be taught in PFMT. For fast contractions, they will be asked to contract and relax the pelvic floor muscles quickly. For slow contractions, they will be asked to contract the pelvic floor muscles slowly, keep them at maximum contraction and relax slowly. Ten slow contractions in addition to 10 fast contractions will be considered as 1 set of exercises. For the first week, they will be asked to do 5 sets of exercises per day, every day. Then, the number of sets will be increased by 5 each week and the number of sets will reach 30 in the 6th week. PFMT will be applied by the patients as a home program every day of the week for 6 weeks.

Other: Exercise

Control group

OTHER

Waiting list will included in control group.

Other: Control

Interventions

Exercise OTHER

Pelvic floor muscle exercise will be given to the exercise group

Exercise group

Control OTHER

No intervention

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis of overactive bladder
• Being volunteer

You may not qualify if:

• have a neurological disorder
• only those with stress urinary incontinence
• presence of advanced pelvic organ prolapse (stage 3-4)
• Having a mental problem that will prevent cooperation in evaluation and / or applications
• Women with the presence of malignant condition

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Seyda Toprak Celenay

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000; sydtoprak@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Participants will be randomly divided into two groups (control and exercise) for treatment.

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 6, 2021

Record last verified: 2021-06