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

NCT ID: NCT07030608

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-03-01

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.

Detailed Description

This is a randomized controlled experimental study . The research was carried out in the Erzurum City Hospital. This study, which was conducted to examine the effect of pelvic floor muscle exercises *PFME* on sexual life in women with overactive bladder *OAB* , was conducted with 64 women (32 women: control group, 32 women: intervention group) who applied to the Erzurum City Hospital Urology Polyclinic between December 1, 2021 and December 1, 2024.

Research Hypotheses:

H1: Overactive bladder symptoms are positively affected in women with OAB who perform pelvic floor exercises.

H2: Sexual function is positively affected in women with OAB who perform pelvic floor exercises.

H3: Depression symptoms are positively affected in women with OAB who perform pelvic floor exercises.

H4: Sexual quality of life is positively affected in women with OAB who perform pelvic floor exercises.

H5: Pelvic muscle strength increases in women with OAB who undergo pelvic floor muscle training.

H6: The contraction, relaxation, and percentage of maximum voluntary contraction *MVC* % of pelvic floor muscles improve in women with OAB who undergo pelvic floor muscle training.

Implementation:

The intervention group performed a pelvic floor muscle exercise program in addition to the pharmacological treatment routinely provided at the hospital. Pelvic floor muscle exercises-including identifying the correct muscle, contraction, and relaxation-were taught by the researcher using biofeedback via the Simplex device. The training was reinforced through the use of biofeedback techniques, including a game integrated into the Simplex software, as well as verbal cues provided by the researcher .

To ensure proper continuation of the exercises and to help participants remember them, a handbook prepared by the researcher was provided (Pelvic Floor Muscle Exercise Training Handbook for Women with Overactive Bladder). Participants were asked to complete the Pelvic Floor Muscle Exercise Practice Tracking Form after each exercise session.

Additionally, the women were contacted weekly by the researcher via telephone. They were either invited to the hospital for follow-up or visited at home for evaluation and feedback.

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).

Alternatively (preferred option):

Contract for 6 seconds, relax for 6 seconds. Repeat 75 times. Perform 2 sessions per day (total of 150 contractions per day).

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

Conditions

Sexual Function; Over Active Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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).

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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).

Interventions

Exercise

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Nezihe KIZILKAYA BEJI

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biruni Üniversitesi

Istanbul, Zeytinburnu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/60-11

Identifier Type: -

Identifier Source: org_study_id