The Effect Of Pelvic Floor Muscle Exercises On Sexual Life In Women With Overactive Bladder

NCT07030608 | Completed

• 1 other identifier: 2021/60-11
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled experimental study to determine the effect of pelvic floor muscle exercise on sexual life. The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention ond control groups (n=32). Pelvic Floor Muscle Exercise \*PFME\* was applied to the intervention group for 6 weeks with the Simplex Device accompanied by biofeedback in accordance with the PFME application procedure. The control group received routine care.

Conditions

Sexual Function; Over Active Bladder

Keywords

over active bladder; Pelvic Floor Muscle; sexual function

Outcome Measures

Primary Outcomes (6)

• Over active bladder questionnaire

  This questionnaires evaluates urination frequency, sudden feeling of urgency, nocturia, urge type incontinence symptoms. It consists of 8 questions that patients can rate the severity of their complaints as none (0); very little (1); a little (2); quite a bit (3); a lot (4); and very much (5).

  Change from beginning of the study and after 6th week of exercise program

• pelvic floor muscle contraction strength

  Pelvic floor muscle strength measurement by digital palpation

  Change from beginning of the study and after 6th week of exercise program

• pelvic floor muscle contraction strength

  Pelvic floor muscle strength measurement by Simplex device

  Change from beginning of the study and after 6th week of exercise program

• pelvic floor muscle relaxation strength

  Pelvic floor muscle strength measurement by Simplex device

  Change from beginning of the study and after 6th week of exercise program

• Female Sexual Function Index Scores ≤ 26.55

  The Female Sexual Function Index consists of 19 items that measure six domains of female sexual function: Desire (2 items) Arousal (4 items) Lubrication (4 items) Orgasm (3 items) Satisfaction (3 items) Pain (3 items; includes discomfort during or after vaginal penetration) Each item is scored on a Likert-type scale, typically ranging from 0 or 1 to 5.Total score range: 2.0 to 36.0 Cut-off score: A total FSFI score of ≤26.55 is commonly used to indicate female sexual dysfunction (FSD).

  Change from beginning of the study and after 6th week of exercises program

• Center of Epidemiologic Studies Depression Scale

  The Center of Epidemiologic Studies Depression Scale is designed to assess the frequency and severity of symptoms associated with depression. The original CES-D contains 20 items.Each item is scored on a 4-point Likert scale: 0 = Rarely or none of the time (\<1 day) 1. = Some or a little of the time (1-2 days) 2. = Occasionally or a moderate amount of time (3-4 days) 3. = Most or all of the time (5-7 days) Total scores range from 0 to 60. A score of 16 or higher is generally used as a cut-off to indicate significant levels of depressive symptoms, though this is not a diagnostic tool.

  Change from beginning of the study and after 6th week of exercise program.

Study Arms (2)

Control

NO INTERVENTION

Women in the control group did not receive any intervention or pelvic floor muscle exercise training.

Intervention

EXPERIMENTAL

The intervention group performed a pelvic floor muscle exercise program in addition to the pharmacological treatment routinely provided at the hospital. Pelvic Floor Muscle Exercise Program Week 1: Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day). Week 2: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Week 3: Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day). Weeks 4-24: Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day). After Week 24: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Pelvic Floor Muscle Exercise Program Week 1: Contract the pelvic floor muscles for 6 seconds, then relax for 6 seconds. Repeat 25 times. Perform 3 sessions per day (total of 75 contractions per day). Week 2: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day). Week 3: Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 3 sessions per day (total of 225 contractions per day). Weeks 4-24: Contract for 6 seconds, relax for 6 seconds. Repeat 100 times. Perform 3 sessions per day (total of 300 contractions per day). After Week 24: Contract for 6 seconds, relax for 6 seconds. Repeat 50 times. Perform 3 sessions per day (total of 150 contractions per day).

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between 18 and 70 years of age
• Speaking Turkish
• Being literate
• Having a diagnosis of Overactive Bladder (OAB)
• Currently receiving pharmacological treatment for OAB
• Being willing to participate in the study voluntarily

You may not qualify if:

• Presence of perceptual impairments or psychiatric disorders that interfere with communication
• Diagnosis of a neurological disease
• Presence of neuropathy due to Diabetes Mellitus
• Pelvic organ prolapse at Stage 2 or higher
• History of anti-incontinence surgery
• Being pregnant

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni Üniversitesi

Istanbul, Zeytinburnu, 34051, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study included 64 women admitted to the Erzurum City Hospital, who consented to participate. They were divided into intervention and controls groups (n=32). PFME (Pelvic Floor Muscle Exercise) was applied to the intervention group for 6 weeks with the Simplex Device accompanied by biofeedback in accordance with the PFME application procedure. The control group received routine care.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 22, 2025
• Study Start: December 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)