Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607737296841 Date of Registration: 17/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of neuromodulation and pelvic floor muscle Exercise in the treatment of female sexual dysfunction
Official scientific title Efficacy of neuromodulation and pelvic floor muscle Exercise in the treatment of female sexual dysfunction: A randomized controlled trial
Brief summary describing the background and objectives of the trial Female sexual dysfunction (FSD) is defined as persistent, recurrent problems with sexual response, desire, orgasm or pain, which causes distress or strain on a relationship. Sexual dysfunction often has a large impact on quality of life.Treatment presents difficulties for medical professionals and therapists because of the numerous potential causes and variations of FSD. Different types of peripheral neuromodulation therapies, such as sacral neuromodulation, transcutaneous tibial neuromodulation, and pudendal anogenital neuromodulation that were directed to treat bladder dysfunction, also showed an improvement in sexual function. Transcutaneous tibial nerve stimulation using TENS is a non-invasive electrical stimulation of the tibial nerve using surface electrodes, this nerve shares a metameric region with the somatic and parasympathetic innervation of the pelvic floor, also Pelvic floor muscle training (PFMT) may enhance women's sexual function through a variety of processes. The aim of this research is to study the effect of neuromodulation using transcutaneous tibial nerve stimulation combined with pelvic floor muscle exercise program on patients suffering from disorders of orgasm.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied female sexual dysfunction
Purpose of the trial Rehabilitation
Anticipated trial start date 06/07/2026
Actual trial start date
Anticipated date of last follow up 06/01/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 1.transcutaneous electrical nerve stimulation for tibial nerve. 2.Pelvic Floor Muscle Exercise 12 sessions (3 sessions per week for 4 weeks) of transcutaneous electrical nerve stimulation of the tibial nerve Pelvic Floor Muscle Exercise 10/15min, 3 times daily 4 weeks transcutaneous electrical nerve stimulation of the tibial nerve using -----apparatus. Each session will last for 30 minutes. Four electrodes will be used to stimulate bilateral tibial nerves, the first electrode will be placed cephalic to the internal malleolus; the second electrode on the calcaneus area. The following parameters will be used; frequency: 10 Hz, with a pulse width of 200 μs and intensity will be individually adjusted to each participant. Exercise Regimen: Weeks 1-4: Participants will perform slow-twitch contractions (sustained hold for 5-10 seconds, followed by 10 seconds of rest) for 15 repetitions, three times daily. Then progressed to include fast-twitch contractions (quick, maximal squeezes followed by complete relaxation) for 10 repetitions, integrated with the slow-twitch regimen. Functional Integration: From week 2, participants will be instructed in techniques to incorporate pelvic floor contractions during sexual arousal and activity. 50
Control Group Pelvic Floor Muscle Exercise 10/15min, 3 times daily 4 weeks Exercise Regimen: § Weeks 1-4: Participants will perform slow-twitch contractions (sustained hold for 5-10 seconds, followed by 10 seconds of rest) for 15 repetitions, three times daily. Then progressed to include fast-twitch contractions (quick, maximal squeezes followed by complete relaxation) for 10 repetitions, integrated with the slow-twitch regimen. Functional Integration: From week 2, participants will be instructed in techniques to incorporate pelvic floor contractions during sexual arousal and activity. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged between 18 and 55 years and sexually active. 2. Diagnosed with sexual dysfunction (disorders of orgasm). 3. A score of ≤ 26.55 on the Arabic form of the Female Sexual Function Index (FSFI) total score, confirming sexual dysfunction 1. Females suffering from psychiatric disorders or sexual disorders due to male factor. 2. Presence of severe psychiatric or neurological disorders. 3. Pregnancy, lactation, or planning pregnancy during the study period. 4. Major pelvic organ prolapse (POP-Q stage > II). 5. Known severe pelvic floor hypertonicity. 6. Previous pelvic surgery or radiotherapy within the last 12 months. 7. Active urinary or genital tract infection or diagnosed with bladder dysfunction. 8. Receiving electrical stimulation for bladder or sexual problems, recent use of TENS on their pelvis, back or legs, 9. An implanted pacemaker, defibrillator, spinal cord stimulator, or other nerve stimulator. 10. Patients taking any investigational drug. 11. Malignancy or other chronic medical condition. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/06/2026 Faculty of Medicine Ain shams University Instituianal review board
Ethics Committee Address
Street address City Postal code Country
Ramsis street Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Symptoms improvement: the Female Sexual Function Index (FSFI): A validated 19-item questionnaire covering six domains (desire, arousal, lubrication, orgasm, satisfaction, pain). The total score (range 2-36) is the primary indicator of sexual function, with a higher score indicating better function 4 weeks post intervention
Secondary Outcome Visual Analogue Scale (VAS) for Sexual Satisfaction: A 0-100 mm scale where participants rate their overall sexual satisfaction. · Pelvic Floor Muscle Strength: using the modified Oxford Muscle Grading System (MOS) 4 weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals. Ramsis street Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hala Sabah Ramsis street Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams University Faculty of Medicine Rehabilitation and Physical Medicine department Ramsis street Cairo 11591 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hala Sabah halams@medu.asu.edu.eg 01006720301 Ramsis street
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor Faculty of medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries Samia Rashad drsamiamohamed@med.asu.edu.eg 01005856783 El mahkama street
City Postal code Country Position/Affiliation
Cairo Egypt Associate Proffessor Faculty of medicine Ain Shams univerisity
Role Name Email Phone Street address
Scientific Enquiries .Omnia Abubakr omniabakr@med.asu.edu.eg 01110344643 Helioplis street
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor Faculty of Medicine Ain shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes de identified individual participant data underlying the final results of this study will be made available to qualified researchers upon reasonable request Study Protocol Date will be avaliable beginning 6 months after publication of the main study results and will remain accessible for up to 3 years data requests must be submitted with a methodologically sound research proposal, by email to the primary investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 10/07/2026 our age group is from 18 up to 55 Adult: 18 Year(s)-44 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2026 Correction, it was not clear Primary Outcome, Symptoms improvement: the Female Sexual Function Index (FSFI): A validated 19-item questionnaire covering six domains (desire, arousal, lubrication, orgasm, satisfaction, pain). The total score (range 2-36) is the primary indicator of sexual function, with a higher score indicating better function, 4 weeks Primary Outcome, Symptoms improvement: the Female Sexual Function Index (FSFI): A validated 19-item questionnaire covering six domains (desire, arousal, lubrication, orgasm, satisfaction, pain). The total score (range 2-36) is the primary indicator of sexual function, with a higher score indicating better function, 4 weeks post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/07/2026 Correction, it was not clear Secondary Outcome, Visual Analogue Scale (VAS) for Sexual Satisfaction: A 0-100 mm scale where participants rate their overall sexual satisfaction. · Pelvic Floor Muscle Strength: using the modified Oxford Muscle Grading System (MOS) , 4 weeks Secondary Outcome, Visual Analogue Scale (VAS) for Sexual Satisfaction: A 0-100 mm scale where participants rate their overall sexual satisfaction. · Pelvic Floor Muscle Strength: using the modified Oxford Muscle Grading System (MOS) , 4 weeks post intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/07/2026 correction TRUE, Faculty of Medicine Ain shams University Instituianal review board , Ramsis street, Cairo , 11591, Egypt, , 13 Jun 2026, 20226857539, REC-FMASU@med.asu.edu.eg, 43632_39943_4737.pdf TRUE, Faculty of Medicine Ain shams University Instituianal review board , Ramsis street, Cairo , 11591, Egypt, , 13 Jun 2026, 20226857539, REC-FMASU@med.asu.edu.eg, 43632_39943_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/07/2026 correction TRUE, Faculty of Medicine Ain shams University Instituianal review board , Ramsis street, Cairo , 11591, Egypt, , 13 Jun 2026, 20226857539, REC-FMASU@med.asu.edu.eg, 43632_39943_4737.pdf TRUE, Faculty of Medicine Ain shams University Instituianal review board , Ramsis street, Cairo , 11591, Egypt, , 13 Jun 2026, 20226857539, REC-FMASU@med.asu.edu.eg, 43632_39943_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 10/07/2026 correction Individual, Ramsis street, Cairo, 11591, Egypt, Self Funded, Individual by Hala Sabah , Ramsis street, Cairo, 11591, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 17/07/2026 PACTR Admin Individual by Hala Sabah , Ramsis street, Cairo, 11591, Egypt, Self Funded, Hala Sabah , Ramsis street, Cairo, 11591, Egypt, Self Funded,