An interventional study of Exercise in Sexual Function and Over Active Bladder, sponsored by Biruni University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Biruni University · Not applicable, Interventional, and Supportive care
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.
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.
Biruni University is the lead sponsor of 172 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Women in the control group did not receive any intervention or pelvic floor muscle exercise training.
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
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).
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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Change from beginning of the study and after 6th week of exercise program.
Plan to share: No — The investigators did not obtain permission from the participants to share their data with other researchers.
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